Organon Usa Inc.

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Organon Usa Inc. Drugs

Pregnyl

Pregnyl

For intramuscular use only. The dosage regimen employed in any particular case will depend upon the indication for the use, the age and weight of the patient, and the physician's preference. The following regimens have been advocated by various authorities:

Prepubertal cryptorchidism not due to anatomical obstruction. Therapy is usually instituted in children between the ages of 4 and 9.
4000 USP units 3 times weekly for 3 weeks. 5000 USP units every second day for 4 injections. 15 injections for 500 to 1000 USP units over a period of 6 weeks. 500 USP units 3 times weekly for 4 to 6 weeks. If this course of treatment is not successful, another series is begun 1 month later, giving 1000 USP units per injection.
Selected cases of hypogonadotropic hypogonadism in males.
500 to 1000 USP units 3 times a week for 3 weeks, followed by the same dose twice a week for 3 weeks. 4000 USP units 3 times weekly for 6 to 9 months, following which the dosage may be reduced to 2000 USP units 3 times weekly for an additional 3 months.
Induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure and who has been appropriately pretreated with human menotropins. (See prescribing information for menotropins for dosage and administration for that drug product.)

5000 to 10,000 USP units 1 day following the last dose of menotropins. (A dosage of 10,000 USP units is recommended in the labeling for menotropins.)

Directions for Reconstitution

Two-vial package: Withdraw sterile air from lyophilized vial and inject into diluent vial. Remove 1–10 mL from diluent and add to lyophilized vial; agitate gently until powder is completely dissolved in solution.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

IMPORTANT: USE COMPLETELY AFTER RECONSTITUTION. RECONSTITUTED SOLUTION IS STABLE FOR 60 DAYS WHEN REFRIGERATED.
Nuvaring

Nuvaring

2.1 How to Use NuvaRing

To achieve maximum contraceptive effectiveness, NuvaRing must be used as directed [see Dosing and Administration (2.2)]. One NuvaRing is inserted in the vagina. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.

The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down. The ring is to be compressed and inserted into the vagina. The exact position of NuvaRing inside the vagina is not critical for its function. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks. This means that the ring should be removed three weeks later on the same day of the week as it was inserted and at about the same time.

NuvaRing can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out. The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet).

After a one-week break, during which a withdrawal bleed usually occurs, a new ring is inserted on the same day of the week as it was inserted in the previous cycle. The withdrawal bleed usually starts on Day 2-3 after removal of the ring and may not have finished before the next ring is inserted. In order to maintain contraceptive effectiveness, the new ring must be inserted exactly one week after the previous one was removed even if menstrual bleeding has not finished.

2.2 How to Start Using NuvaRing

IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of NuvaRing.

No Hormonal Contraceptive Use in the Preceding Cycle:

The woman should insert NuvaRing on the first day of her menstrual bleeding. NuvaRing may also be started on Days 2-5 of the woman's cycle, but in this case a barrier method, such as male condoms with spermicide, should be used for the first seven days of NuvaRing use in the first cycle.

Changing From a CHC:

The woman may switch from her previous CHC on any day, but at the latest on the day following the usual hormone-free interval, if she has been using her hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant.

Changing From a Progestin-Only Method (progestin-only pill [POP], Implant, or Injection or a Progestin-Releasing Intrauterine System [IUS]):

The woman may switch from the POP on any day; instruct her to start using NuvaRing on the day after she took her last POP. She should switch from an implant or the IUS on the day of its removal, and from an injectable on the day when the next injection would be due. In all of these cases, the woman should use an additional barrier method such as a male condom with spermicide, for the first seven days.

Use after Abortion or Miscarriage

The woman may start using NuvaRing within the first five days following a complete first trimester abortion or miscarriage, and she does not need to use an additional method of contraception. If use of NuvaRing is not started within five days following a first trimester abortion or miscarriage, the woman should follow the instructions for "No Hormonal Contraceptive Use in the Preceding Cycle." In the meantime, she should be advised to use a non-hormonal contraceptive method.

Start NuvaRing no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism. [See Contraindications (4), and Warnings and Precautions (5.1).]

Following Childbirth

The use of NuvaRing may be initiated no sooner than four weeks postpartum in women who elect not to breastfeed, due to the increased risk of thromboembolism in the postpartum period. [See Contraindications (4), and Warnings and Precautions (5.1).]

Advise women who are breastfeeding not to use NuvaRing but to use other forms of contraception until the child is weaned.

If a woman begins using NuvaRing postpartum, instruct her to use an additional method of contraception, such as male condoms with spermicide, for the first seven days. If she has not yet had a period, consider the possibility of ovulation and conception occurring prior to initiation of NuvaRing.

2.3 Deviations from the Recommended Regimen

To prevent loss of contraceptive efficacy, advise women not to deviate from the recommended regimen. NuvaRing should be left in the vagina for a continuous period of three weeks.

Inadvertent Removal or Expulsion

NuvaRing can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement. NuvaRing should be left in the vagina for a continuous period of three weeks. If the ring is accidentally expelled and is left outside of the vagina for less than three hours, contraceptive efficacy is not reduced. NuvaRing can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within three hours. If NuvaRing is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration.

If NuvaRing is out of the vagina for more than three continuous hours:

During Weeks 1 and 2: Contraceptive efficacy may be reduced. The woman should reinsert the ring as soon as she remembers. A barrier method such as condoms with spermicides must be used until the ring has been used continuously for seven days.

During Week 3: The woman should discard that ring. One of the following two options should be chosen:
Insert a new ring immediately. Inserting a new ring will start the next three-week use period. The woman may not experience a withdrawal bleed from her previous cycle. However, breakthrough spotting or bleeding may occur. Insert a new ring no later than seven days from the time the previous ring was removed or expelled, during which time she may have a withdrawal bleed. This option should only be chosen if the ring was used continuously for at least seven days prior to inadvertent removal/expulsion.
In either case, a barrier method such as condoms with spermicides must be used until the new ring has been used continuously for seven days.

Prolonged Ring-Free Interval

If the ring-free interval has been extended beyond one week, consider the possibility of pregnancy, and an additional method of contraception, such as male condoms with spermicide, MUST be used until NuvaRing has been used continuously for seven days.

Prolonged Use of NuvaRing

If NuvaRing has been left in place for up to one extra week (i.e., up to four weeks total), the woman will remain protected. NuvaRing should be removed and the woman should insert a new ring after a one-week ring-free interval.

If NuvaRing has been left in place for longer than four weeks, instruct the woman to remove the ring, and rule out pregnancy. If pregnancy is ruled out, NuvaRing may be restarted, and an additional method of contraception, such as male condoms with spermicide, MUST be used until a new NuvaRing has been used continuously for seven days.

Ring Breakage

There have been reported cases of NuvaRing disconnecting at the weld joint. This is not expected to affect the contraceptive effectiveness of NuvaRing. In the event of a disconnected ring, vaginal discomfort or expulsion (slipping out) is more likely to occur. If a woman discovers that her NuvaRing has disconnected, she should discard the ring and replace it with a new ring.

2.4 In the Event of a Missed Menstrual Period
If the woman has not adhered to the prescribed regimen (NuvaRing has been out of the vagina for more than three hours or the preceding ring-free interval was extended beyond one week), consider the possibility of pregnancy at the time of the first missed period and discontinue NuvaRing use if pregnancy is confirmed. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. If the woman has retained one NuvaRing for longer than four weeks, rule out pregnancy.
2.5 Use with Other Vaginal Products

NuvaRing may interfere with the correct placement and position of a diaphragm. A diaphragm is therefore not recommended as a back-up method with NuvaRing use.

Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by NuvaRing.
Tice Bcg

Tice Bcg

The dose for the intravesical treatment of carcinoma in situ and for the prophylaxis of recurrent papillary tumors consists of 1 vial of TICE® BCG suspended in 50 mL preservative-free saline.

Do not inject subcutaneously or intravenously.

Preparation of Agent

The preparation of the TICE BCG suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG has been prepared. A separate area for the preparation of the TICE BCG suspension is recommended. All equipment, supplies, and receptacles in contact with TICE BCG should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves and take precautions to avoid contact of BCG with broken skin. If preparation cannot be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin.

Option 1 (Using Syringe Method)

Draw 1 mL of sterile, preservative-free saline (0.9% Sodium Chloride Injection USP) at 4–25°C into a small syringe (e.g., 3 mL) and add to 1 vial of TICE BCG to resuspend. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria. Dispense the cloudy TICE BCG suspension into the top end of a catheter-tip syringe which contains 49 mL of saline diluent, bringing the total volume to 50 mL. To mix, gently rotate the syringe.

Option 2 (Using Reconstitution Accessories)

Reconstitution Accessories may be provided with each TICE BCG product order. Please refer to the Reconstitution Accessories Instructions provided with the accessories for a full description of the product reconstitution procedures using these accessories.

The reconstituted TICE BCG should be kept refrigerated (2–8°C), protected from exposure to direct sunlight, and used within 2 hours. Unused solution should be discarded after 2 hours.

Note: DO NOT filter the contents of the TICE BCG vial. Precautions should be taken to avoid exposing the TICE BCG to direct sunlight. Bacteriostatic solutions must be avoided. In addition, use only sterile, preservative-free saline, 0.9% Sodium Chloride Injection USP as diluent.

Treatment and Schedule

Allow 7 to 14 days to elapse after bladder biopsy before TICE BCG is administered. Patients should not drink fluids for 4 hours before treatment and should empty their bladder prior to TICE BCG administration. The reconstituted TICE BCG is instilled into the bladder by gravity flow via the catheter. DO NOT depress plunger and force the flow of the TICE BCG. The TICE BCG is retained in the bladder 2 hours and then voided. Patients unable to retain the suspension for 2 hours should be allowed to void sooner, if necessary.

While the BCG is retained in the bladder, the patient ideally should be repositioned from left side to right side and also should lie upon the back and the abdomen, changing these positions every 15 minutes to maximize bladder surface exposure to the agent.

A standard treatment schedule consists of 1 intravesical instillation per week for 6 weeks. This schedule may be repeated once if tumor remission has not been achieved and if the clinical circumstances warrant. Thereafter, intravesical TICE BCG administration should continue at approximately monthly intervals for at least 6 to 12 months. There are no data to support the interchangeability of BCG LIVE products.
Follistim Aq

Follistim Aq

2.1 General Dosing Information
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is not clear and colorless or has particles in it, the solution should not be used. Do not add any other medicines into the Follistim AQ Cartridge. Follistim AQ Cartridge with the pen injector device delivers on average an 18% higher amount of follitropin beta when compared to reconstituted Follistim delivered with a conventional syringe and needle. When administering Follistim AQ Cartridge, a lower starting dose and lower dose adjustments (as compared to reconstituted Follistim) should be considered. For that purpose the following Dose Conversion Table is provided: Table 1: Follistim AQ Cartridge Administered Subcutaneously With the Follistim Pen Dose Conversion Table* Lyophilized recombinant FSH dosing withampules or vials, using conventional syringe Follistim AQ Cartridgedosing with the Follistim Pen * Each value represents an 18% difference rounded to the nearest 25 IU increment. 75 IU 50 IU 150 IU 125 IU 225 IU 175 IU 300 IU 250 IU 375 IU 300 IU 450 IU 375 IU
2.2 Recommended Dosing in Anovulatory Women Undergoing Ovulation Induction

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
A starting daily dose of 50 international units of Follistim AQ Cartridge is administered [see Dosage and Administration (2.1)] subcutaneously daily for at least the first 7 days. Subsequent dosage adjustments are made at weekly intervals based upon ovarian response. If an increase in dose is indicated by the ovarian response, the increase should be made by 25 or 50 international units of Follistim AQ Cartridge at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate ovarian response.The following should be considered when planning the woman's individualized dose: Appropriate Follistim AQ Cartridge dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. The maximum, individualized, daily dose of Follistim AQ Cartridge is 250 international units. Treatment should continue until ultrasonic visualizations and/or serum estradiol determinations approximate the pre-ovulatory conditions seen in normal individuals. When pre-ovulatory conditions are reached, 5,000 to 10,000 international units of hCG are used to induce final oocyte maturation and ovulation.The administration of hCG must be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Follistim AQ Cartridge therapy [see Warnings and Precautions (5.1, 5.2, 5.10)]. The woman and her partner should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent [see Warnings and Precautions (5.10)]. During treatment with Follistim AQ Cartridge and during a two-week post-treatment period, the woman should be assessed at least every other day for signs of excessive ovarian stimulation.It is recommended that Follistim AQ Cartridge administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs. Most OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days post-ovulation.
2.3 Recommended Dosing in Normal Ovulatory Women Undergoing Controlled Ovarian Stimulation as Part of an In Vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI) Cycle

The dosing scheme follows a stepwise approach and is individualized for each woman.
A starting dose of 200 international units (actual cartridge doses) of Follistim AQ Cartridge is administered [see Dosage and Administration (2.1)] subcutaneously daily for at least the first 7 days of treatment. Subsequent to the first 7 days of treatment, the dose can be adjusted down or up based upon the woman's ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Dosage reduction in high responders can be considered from the 6th day of treatment onward according to individual response.The following should be considered when planning the woman's individualized dose: For most normal responding women, the daily starting dose can be continued until pre-ovulatory conditions are achieved (seven to twelve days). For low or poor responding women, the daily dose should be increased according to the ovarian response. The maximum, individualized, daily dose of Follistim AQ Cartridge is 500 international units. For high responding women [those at particular risk of abnormal ovarian enlargement and/or ovarian hyperstimulation syndrome (OHSS)], decrease or temporarily stop the daily dose, or discontinue the cycle according to individual response [see Warnings and Precautions (5.1, 5.2, 5.10)]. When a sufficient number of follicles of adequate size are present, dosing of Follistim AQ Cartridge is stopped and final maturation of the oocytes is induced by administering hCG at a dose of 5,000 to 10,000 international units. The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Follistim AQ Cartridge therapy [see Warnings and Precautions (5.1, 5.2, 5.10)]. Oocyte (egg) retrieval should be performed 34 to 36 hours following the administration of hCG.
2.4 Recommended Dosing for Induction of Spermatogenesis in Men
Pretreatment with hCG is required prior to concomitant therapy with Follistim AQ Cartridge and hCG. An initial dosage of 1,500 international units of hCG should be administered at twice weekly intervals to normalize serum testosterone levels. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the hCG dose can be increased to 3,000 international units twice weekly [see Clinical Studies (14.3)]. After normal serum testosterone levels have been reached, Follistim AQ Cartridge should be administered by subcutaneous injection concomitantly with hCG treatment. Follistim is given at a dosage of 450 international units per week, as either 225 international units twice weekly or 150 international units three times per week, in combination with the same hCG dose used to normalize testosterone levels. Based on delivery of a higher dose of follitropin beta with the Follistim AQ Cartridge and pen injector [see Dosage and Administration (2.1)], a lower dose of Follistim AQ Cartridge may be considered.The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months.
Ganirelix Acetate

Ganirelix Acetate

After initiating FSH therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Ganirelix Acetate should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome).

Directions for Using Ganirelix Acetate Injection
Ganirelix Acetate Injection is supplied in a sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only. Wash hands thoroughly with soap and water. The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding. With syringe held upward, remove needle cover. Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection. The needle should be inserted at the base of the pinched-up skin at an angle of 45–90° to the skin surface. When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes. Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. Use the sterile, prefilled syringe only once and dispose of it properly.
Nexplanon

Nexplanon

The efficacy of NEXPLANON does not depend on daily, weekly or monthly administration.

All healthcare providers should receive instruction and training prior to performing insertion and/or removal of NEXPLANON.

A single NEXPLANON implant is inserted subdermally in the upper arm. To reduce the risk of neural or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. The implant should be inserted subdermally just under the skin, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localization and/or removal can be difficult or impossible [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. NEXPLANON must be inserted by the expiration date stated on the packaging. NEXPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

2.1 Initiating Contraception with NEXPLANON

IMPORTANT: Rule out pregnancy before inserting the implant.

Timing of insertion depends on the woman's recent contraceptive history, as follows:

• No preceding hormonal contraceptive use in the past month

NEXPLANON should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

• Switching contraceptive method to NEXPLANON

Combination hormonal contraceptives:

NEXPLANON should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of removal of the vaginal ring or transdermal patch. At the latest, NEXPLANON should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive.

If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

Progestin-only contraceptives:

There are several types of progestin-only methods. NEXPLANON should be inserted as follows:
Injectable Contraceptives: Insert NEXPLANON on the day the next injection is due. Minipill: A woman may switch to NEXPLANON on any day of the month. NEXPLANON should be inserted within 24 hours after taking the last tablet. Contraceptive implant or intrauterine system (IUS): Insert NEXPLANON on the same day the previous contraceptive implant or IUS is removed.
If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

• Following abortion or miscarriage
First Trimester: NEXPLANON should be inserted within 5 days following a first trimester abortion or miscarriage. Second Trimester: Insert NEXPLANON between 21 to 28 days following second trimester abortion or miscarriage.
If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.

• Postpartum
Not Breastfeeding: NEXPLANON should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. Breastfeeding: NEXPLANON should be inserted after the fourth postpartum week [see Use in Specific Populations (8.3)]. The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
2.2 Insertion of NEXPLANON

The basis for successful use and subsequent removal of NEXPLANON is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Both the healthcare provider and the woman should be able to feel the implant under the skin after placement.

All healthcare providers performing insertions and/or removals of NEXPLANON should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of NEXPLANON will be sent upon request free of charge [1-877-467-5266].

Preparation

Prior to inserting NEXPLANON carefully read the instructions for insertion as well as the full prescribing information.

Before insertion of NEXPLANON, the healthcare provider should confirm that:
The woman is not pregnant nor has any other contraindication for the use of NEXPLANON [see Contraindications (4)]. The woman has had a medical history and physical examination, including a gynecologic examination, performed. The woman understands the benefits and risks of NEXPLANON. The woman has received a copy of the Patient Labeling included in packaging. The woman has reviewed and completed a consent form to be maintained with the woman's chart. The woman does not have allergies to the antiseptic and anesthetic to be used during insertion.
Insert NEXPLANON under aseptic conditions.

The following equipment is needed for the implant insertion:
An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional) Local anesthetic, needles, and syringe Sterile gauze, adhesive bandage, pressure bandage
Insertion Procedure

Step 1. Have the woman lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head (Figure 1).

Figure 1

Step 2. Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissue (Figure 2). The implant should be inserted subdermally just under the skin [see Warnings and Precautions (5.1)].

Step 3. Make two marks with a sterile marker: first, mark the spot where the etonogestrel implant will be inserted, and second, mark a spot a few centimeters proximal to the first mark (Figure 2). This second mark will later serve as a direction guide during insertion.

Figure 2

Step 4. Clean the insertion site with an antiseptic solution.

Step 5. Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 mL of 1% lidocaine just under the skin along the planned insertion tunnel).

Step 6. Remove the sterile preloaded disposable NEXPLANON applicator carrying the implant from its blister. The applicator should not be used if sterility is in question.

Step 7. Hold the applicator just above the needle at the textured surface area. Remove the transparent protection cap by sliding it horizontally in the direction of the arrow away from the needle (Figure 3). If the cap does not come off easily, the applicator should not be used. You can see the white colored implant by looking into the tip of the needle. Do not touch the purple slider until you have fully inserted the needle subdermally, as it will retract the needle and prematurely release the implant from the applicator.

Figure 3

Step 8. With your free hand, stretch the skin around the insertion site with thumb and index finger (Figure 4).

Figure 4

Step 9. Puncture the skin with the tip of the needle slightly angled less than 30° (Figure 5).

Figure 5

Step 10. Lower the applicator to a horizontal position. While lifting the skin with the tip of the needle (Figure 6), slide the needle to its full length. You may feel slight resistance but do not exert excessive force. If the needle is not inserted to its full length, the implant will not be inserted properly.

You can best see movement of the needle, and that it is inserted just under the skin, if you are seated and are looking at the applicator from the side and NOT from above. In this position, you can clearly see the insertion site and the movement of the needle just under the skin.

Figure 6

Step 11. Keep the applicator in the same position with the needle inserted to its full length. If needed, you may use your free hand to keep the applicator in the same position during the following procedure. Unlock the purple slider by pushing it slightly down. Move the slider fully back until it stops (Figure 7). The implant is now in its final subdermal position, and the needle is locked inside the body of the applicator. The applicator can now be removed. If the applicator is not kept in the same position during this procedure or if the purple slider is not completely moved to the back, the implant will not be inserted properly.

Figure 7

Step 12. Always verify the presence of the implant in the woman's arm immediately after insertion by palpation. By palpating both ends of the implant, you should be able to confirm the presence of the 4 cm rod (Figure 8). See section below "If the rod is not palpable".

Figure 8

Step 13. Place a small adhesive bandage over the insertion site. Request that the woman palpate the implant.

Step 14. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage over the insertion site after 3 to 5 days.

Step 15. Complete the USER CARD and give it to the woman to keep. Also, complete the PATIENT CHART LABEL and affix it to the woman's medical record.

Step 16. The applicator is for single use only and should be disposed in accordance with the Center for Disease Control and Prevention guidelines for handling of hazardous waste.

If the rod is not palpable:

If you cannot feel the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply:
Check the applicator. The needle should be fully retracted and only the purple tip of the obturator should be visible. Use other methods to confirm the presence of the implant. Given the radiopaque nature of the implant, suitable methods for localization are two-dimensional X-ray and X-ray computerized tomography (CT scan). Ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI) may be used. If these methods fail, call 1-877-467-5266 for information on the procedure for measuring etonogestrel blood levels.
Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method, such as condoms.

Once the non-palpable implant has been located, removal is recommended [see Warnings and Precautions (5.1)].

2.3 Removal of NEXPLANON

Preparation

Before initiating the removal procedure, the healthcare provider should carefully read the instructions for removal and consult the USER CARD and/or the PATIENT CHART LABEL for the location of the implant. The exact location of the implant in the arm should be verified by palpation. [See Dosage and Administration (2.3), Localization and Removal of a Non-Palpable Implant.]

Procedure for Removal of an Implant that is Palpable

Before removal of the implant, the healthcare provider should confirm that:
The woman does not have allergies to the antiseptic or anesthetic to be used.
Remove the implant under aseptic conditions.

The following equipment is needed for removal of the implant:
An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional) Local anesthetic, needles, and syringe Sterile scalpel, forceps (straight and curved mosquito) Skin closure, sterile gauze, adhesive bandage and pressure bandages
Removal Procedure

Step 1. Clean the site where the incision will be made and apply an antiseptic. Locate the implant by palpation and mark the distal end (end closest to the elbow), for example, with a sterile marker (Figure 9).

Figure 9

Step 2. Anesthetize the arm, for example, with 0.5 to 1 mL 1% lidocaine at the marked site where the incision will be made (Figure 10). Be sure to inject the local anesthetic under the implant to keep it close to the skin surface.

Figure 10

Step 3. Push down the proximal end of the implant (Figure 11) to stabilize it; a bulge may appear indicating the distal end of the implant. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow.

Figure 11

Step 4. Gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and gently remove the implant (Figure 12).

Figure 12

Step 5. If the implant is encapsulated, make an incision into the tissue sheath and then remove the implant with the forceps (Figures 13 and 14).
Figure 13 Figure 14
Step 6. If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision (Figure 15). Flip the forceps over into your other hand (Figure 16).
Figure 15 Figure 16
Step 7. With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant (Figure 17). The implant can then be removed.

Figure 17

Step 8. Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. There have been reports of broken implants while in the patient's arm. In some cases, difficult removal of the broken implant has been reported. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 2.3. [See Dosage and Administration (2.3).] If the woman would like to continue using NEXPLANON, a new implant may be inserted immediately after the old implant is removed using the same incision [see Dosage and Administration (2.4)].

Step 9. After removing the implant, close the incision with a steri-strip and apply an adhesive bandage.

Step 10. Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage in 3 to 5 days.

Localization and Removal of a Non-Palpable Implant

There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position, but may lead to the implant not being palpable at the location in which it was placed. An implant that has been deeply inserted or has migrated may not be palpable and therefore imaging procedures, as described below, may be required for localization.

A non-palpable implant should always be located prior to attempting removal. Given the radiopaque nature of the implant, suitable methods for localization include two-dimensional X-ray and X-ray computer tomography (CT). Ultrasound scanning (USS) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI) may be used. Once the implant has been localized in the arm, the implant should be removed according to the instructions in Dosage and Administration (2.3), Procedure for Removal of an Implant that is Palpable, and the use of ultrasound guidance during the removal should be considered.

If the implant cannot be found in the arm after comprehensive localization attempts, consider applying imaging techniques to the chest as rare events of migration to the pulmonary vasculature have been reported. If the implant is located in the chest, surgical or endovascular procedures may be needed for removal; healthcare providers familiar with the anatomy of the chest should be consulted.

If at any time these imaging methods fail to locate the implant, etonogestrel blood level determination can be used for verification of the presence of the implant. For details on etonogestrel blood level determination, call 1-877-467-5266 for further instructions.

If the implant migrates within the arm, removal may require a minor surgical procedure with a larger incision or a surgical procedure in an operating room. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm.

Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.

2.4 Replacing NEXPLANON

Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 2.2 Insertion of NEXPLANON.

The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. If the same incision is being used to insert a new implant, anesthetize the insertion site [for example, 2 mL lidocaine (1%)] applying it just under the skin along the 'insertion canal.'

Follow the subsequent steps in the insertion instructions [see Dosage and Administration (2.2)].
Implanon

Implanon

The efficacy of IMPLANON does not depend on daily, weekly or monthly administration.

All healthcare providers should receive instruction and training prior to performing insertion and/or removal of IMPLANON.

A single IMPLANON implant is inserted subdermally in the upper arm. To reduce the risk of neural or vascular injury, the implant should be inserted at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus. The implant should be inserted subdermally just under the skin, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissues. An implant inserted more deeply than subdermally (deep insertion) may not be palpable and the localization and/or removal can be difficult or impossible [see Dosage and Administration (2.3) and Warnings and Precautions (5.1)]. IMPLANON must be inserted by the expiration date stated on the packaging. IMPLANON is a long-acting (up to 3 years), reversible, hormonal contraceptive method. The implant must be removed by the end of the third year and may be replaced by a new implant at the time of removal, if continued contraceptive protection is desired.

2.1 Initiating Contraception with IMPLANON

IMPORTANT: Rule out pregnancy before inserting the implant.

Timing of insertion depends on the woman's recent contraceptive history, as follows:
No preceding hormonal contraceptive use in the past month IMPLANON should be inserted between Day 1 (first day of menstrual bleeding) and Day 5 of the menstrual cycle, even if the woman is still bleeding. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. Switching contraceptive method to IMPLANON Combination hormonal contraceptives: IMPLANON should preferably be inserted on the day after the last active tablet of the previous combined oral contraceptive or on the day of the removal of the vaginal ring or transdermal patch. At the latest, IMPLANON should be inserted on the day following the usual tablet-free, ring-free, patch-free or placebo tablet interval of the previous combined hormonal contraceptive. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. Progestin-only contraceptives: There are several types of progestin-only methods. IMPLANON should be inserted as follows: Injectable Contraceptives: Insert IMPLANON on the day the next injection is due. Minipill: A woman may switch to IMPLANON on any day of the month. IMPLANON should be inserted within 24 hours after taking the last tablet. Contraceptive implant or intrauterine system (IUS): Insert IMPLANON on the same day as the previous contraceptive implant or IUS is removed. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. Following abortion or miscarriage First Trimester: IMPLANON should be inserted within 5 days following a first trimester abortion or miscarriage. Second Trimester: Insert IMPLANON between 21 to 28 days following second trimester abortion or miscarriage. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. Postpartum Not Breastfeeding: IMPLANON should be inserted between 21 to 28 days postpartum. If inserted as recommended, back-up contraception is not necessary. If deviating from the recommended timing of insertion, the woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded. Breastfeeding: IMPLANON should be inserted after the fourth postpartum week [see Use in Specific Populations (8.3)]. The woman should be advised to use a barrier method until 7 days after insertion. If intercourse has already occurred, pregnancy should be excluded.
2.2 Insertion of IMPLANON

The basis for successful use and subsequent removal of IMPLANON is a correct and carefully performed subdermal insertion of the single, rod-shaped implant in accordance with the instructions. Both the healthcare provider and the woman should be able to feel the implant under the skin after placement.

All healthcare providers performing insertions and/or removals of IMPLANON should receive instructions and training prior to inserting or removing the implant. Information concerning the insertion and removal of IMPLANON will be sent upon request free of charge [1-877-IMPLANON (1-877-467-5266)].

Preparation

Prior to inserting IMPLANON carefully read the instructions for insertion as well as the full prescribing information.

Before insertion of IMPLANON, the healthcare provider should confirm that:
The woman is not pregnant nor has any other contraindication for the use of IMPLANON [see Contraindications (4)]. The woman has had a medical history and physical examination, including a gynecologic examination, performed. The woman understands the benefits and risks of IMPLANON. The woman has received a copy of the Patient Labeling included in packaging. The woman has reviewed and completed a consent form to be maintained with the woman's chart. The woman does not have allergies to the antiseptic and anesthetic to be used during insertion.
Insert IMPLANON under aseptic conditions.

The following equipment is needed for the implant insertion:
An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional) Local anesthetic, needles, and syringe Sterile gauze, adhesive bandage, pressure bandage
An applicator and its parts are shown below (Figures 1a and 1b).
Figure 1a (Not to scale) Figure 1b Grooved tip of obturator (enlarged)
The procedure used for IMPLANON insertion is opposite from that of an injection. The obturator keeps IMPLANON in place while the cannula is retracted. The obturator must remain fixed in place while the cannula with needle is retracted from the arm. Do not push the obturator.

Insertion Procedure
Step 1.    Have the woman lie on her back on the examination table with her non-dominant arm flexed at the elbow and externally rotated so that her wrist is parallel to her ear or her hand is positioned next to her head ( Figure 2).
Figure 2

Step 2.    Identify the insertion site, which is at the inner side of the non-dominant upper arm about 8-10 cm (3-4 inches) above the medial epicondyle of the humerus, avoiding the sulcus (groove) between the biceps and triceps muscles and the large blood vessels and nerves that lie there in the neurovascular bundle deeper in the subcutaneous tissue (Figure 3). The implant should be inserted subdermally just under the skin [see Warnings and Precautions (5.1)].
Step 3.    Make two marks with a sterile marker: first, mark the spot where the etonogestrel implant will be inserted, and second, mark a spot a few centimeters proximal to the first mark ( Figure 3). This second mark will later serve as a direction guide during insertion.
Figure 3
Step 4.    Clean the insertion site with an antiseptic solution. Step 5.    Anesthetize the insertion area (for example, with anesthetic spray or by injecting 2 mL of 1% lidocaine just under the skin along the planned insertion tunnel). Step 6.    Remove the sterile pre-loaded disposable IMPLANON applicator carrying the implant from its blister. Keep the IMPLANON needle and rod sterile. The applicator should not be used if sterility is in question. If contamination occurs, use a new package of IMPLANON with a new sterile applicator. Step 7.    Keep the shield on the needle and look for the IMPLANON rod, seen as a white cylinder inside the needle tip. Step 8.    If you don't see the IMPLANON rod, tap the top of the needle shield against a firm surface to bring the implant into the needle tip. Step 9.    Following visual confirmation, lower the IMPLANON rod back into the needle by tapping it back into the needle tip. Then remove the needle shield, while holding the applicator upright. Step 10.     Note that IMPLANON can fall out of the needle. Therefore, after you remove the needle shield, keep the applicator in the upright position until the moment of insertion Step 11.    With your free hand, stretch the skin around the insertion site with thumb and index finger ( Figure 4).
Figure 4
Step 12.    At a slight angle (not greater than 20°), insert only the tip of the needle with the beveled side up into the insertion site ( Figure 5).
Figure 5
Step 13.    Lower the applicator to a horizontal position. Lift the skin up with the tip of the needle, but keep the needle in the subdermal connective tissue ( Figure 6).
Figure 6
Step 14.    While "tenting" (lifting) the skin, gently insert the needle to its full length. Keep the needle parallel to the surface of the skin during insertion ( Figure 7).
Figure 7

Step 15.    If IMPLANON is placed deeply, the removal process can be difficult or impossible. If the needle is not inserted to its full length, the implant may protrude from the insertion site and fall out.
Step 16.    Break the seal of the applicator by pressing the obturator support ( Figure 8).
Figure 8
Step 17.    Turn the obturator 90° in either direction with respect to the needle ( Figure 9).
Figure 9
Step 18.    While holding the obturator fixed in place on the arm, fully retract the cannula ( Figure 10). Note: This procedure is opposite from an injection. Do not push the obturator. By holding the obturator fixed in place on the arm and fully retracting the cannula, the implant will be left in its correct subdermal position. Do not simultaneously retract the obturator and cannula from the patient's arm. Figure 10 In this figure, the right hand is holding the obturator in place while the left hand is retracting the cannula. Step 19.    Confirm that the implant has been inserted by checking the tip of the needle for the absence of the implant. After insertion of the implant, the grooved tip of the obturator will be visible inside the needle ( Figure 11).
Figure 11

Step 20.    Always verify the presence of the implant in the woman's arm immediately after insertion by palpation. By palpating both ends of the implant, you should be able to confirm the presence of the 4-cm rod (Figure 12). See section below "If the rod is not palpable".

Figure 12

Step 21.    Place a small adhesive bandage over the insertion site. Request that the woman palpate the implant.

Step 22.    Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage over the insertion site in 3 to 5 days.

Step 23.    Complete the USER CARD and give it to the woman to keep. Also, complete the PATIENT CHART LABEL and affix it to the woman's medical record.

Step 24.    The applicator is for single use only and should be disposed in accordance with the Center for Disease Control and Prevention guidelines for handling of hazardous waste.

If the rod is not palpable:

If you cannot feel the implant or are in doubt of its presence, the implant may not have been inserted or it may have been inserted deeply:
Check the tip of the needle for the absence of the implant. After insertion of the implant, the grooved tip of the obturator will be visible inside the needle. Use other methods to confirm the presence of the implant. Suitable methods to locate are: ultrasound (US) with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging (MRI). Please note that the IMPLANON rod is not radiopaque and cannot be seen by X-ray or CT scan. If ultrasound and MRI fail, call 1-877-IMPLANON (1-877-467-5266) for information on the procedure for measuring etonogestrel blood levels.
Until the presence of the implant has been verified, the woman should be advised to use a non-hormonal contraceptive method, such as condoms.

Once the non-palpable implant has been located, removal is recommended [see Warnings and Precautions (5.1)].

2.3 Removal of IMPLANON

Preparation

Before initiating the removal procedure, the healthcare provider should carefully read the instructions for removal and consult the USER CARD and/or the PATIENT CHART LABEL for the location of the implant. The exact location of the implant in the arm should be verified by palpation. [See Dosage and Administration (2.3), Localization and Removal of a Non-Palpable Implant.]

Procedure for Removal of an Implant that is Palpable

A non-palpable implant should always be first located prior to removal. Suitable methods for localization include ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging.

Before removal of the implant, the healthcare provider should confirm that:
The woman does not have allergies to the antiseptic or anesthetic to be used.
Remove the implant under aseptic conditions.

The following equipment is needed for removal of the implant:
An examination table for the woman to lie on Sterile surgical drapes, sterile gloves, antiseptic solution, sterile marker (optional) Local anesthetic, needles, and syringe Sterile scalpel, forceps (straight and curved mosquito) Skin closure, sterile gauze, adhesive bandage and pressure bandages
Removal Procedure
Step 1.    Clean the site where the incision will be made and apply an antiseptic. Locate the implant by palpation and mark the distal end (end closest to the elbow), for example, with a sterile marker ( Figure 13).
Figure 13
Step 2.    Anesthetize the arm, for example, with 0.5 to 1 mL 1% lidocaine at the marked site where the incision will be made ( Figure 14). Be sure to inject the local anesthetic under the implant to keep it close to the skin surface.
Figure 14
Step 3.    Push down the proximal end of the implant ( Figure 15) to stabilize it; a bulge may appear indicating the distal end of the implant. Starting at the distal tip of the implant, make a longitudinal incision of 2 mm towards the elbow.
Figure 15
Step 4.    Gently push the implant towards the incision until the tip is visible. Grasp the implant with forceps (preferably curved mosquito forceps) and gently remove the implant ( Figure 16).
Figure 16
Step 5.    If the implant is encapsulated, make an incision into the tissue sheath and then remove the implant with the forceps ( Figures 17 and 18). Figure 17 Figure 18 Step 6.    If the tip of the implant does not become visible in the incision, gently insert a forceps into the incision ( Figure 19). Flip the forceps over into your other hand ( Figure 20). Figure 19 Figure 20 Step 7.    With a second pair of forceps carefully dissect the tissue around the implant and grasp the implant ( Figure 21). The implant can then be removed.
Figure 21

Step 8.    Confirm that the entire implant, which is 4 cm long, has been removed by measuring its length. There have been reports of broken implants while in the patient's arm. In some cases, difficult removal of the broken implant has been reported. If a partial implant (less than 4 cm) is removed, the remaining piece should be removed by following the instructions in section 2.3. [See Dosage and Administration (2.3).] If the woman would like to continue using IMPLANON, a new implant may be inserted immediately after the old implant is removed using the same incision [see Dosage and Administration (2.4)].
Step 9.    After removing the implant, close the incision with a steri-strip and apply an adhesive bandage. Step 10.    Apply a pressure bandage with sterile gauze to minimize bruising. The woman may remove the pressure bandage in 24 hours and the small bandage in 3 to 5 days.
Localization and Removal of a Non-Palpable Implant

There have been occasional reports of migration of the implant; usually this involves minor movement relative to the original position [see Warnings and Precautions (5.1)], but may lead to the implant not being palpable in the location in which it was placed. An implant that has been deeply inserted or has migrated may not be palpable and therefore imaging procedures, as described below, may be required for localization.

A non-palpable implant should always be located prior to attempting removal. Suitable methods for localization include ultrasound with a high-frequency linear array transducer (10 MHz or greater) or magnetic resonance imaging. Once the implant has been localized in the arm, the implant should be removed according to the instructions in Dosage and Administration (2.3), Procedure for Removal of an Implant that is Palpable, and the use of ultrasound guidance during the removal should be considered.

If the implant cannot be found in the arm after comprehensive localization attempts, consult a radiologist familiar with applying advanced imaging techniques to the chest, as rare events of migration to the pulmonary vasculature have been reported. If the implant is located in the chest, surgical or endovascular procedures may be needed for removal; healthcare providers familiar with the anatomy of the chest should be consulted.

If at any time these imaging methods fail to locate the implant, etonogestrel blood level determination can be used for verification of the presence of the implant. For details on etonogestrel blood level determination, call 1-877-IMPLANON (1-877-467-5266) for further instructions.

If the implant migrates within the arm, removal may require a minor surgical procedure with a larger incision or a surgical procedure in an operating room. Removal of deeply inserted implants should be conducted with caution in order to prevent injury to deeper neural or vascular structures in the arm and be performed by healthcare providers familiar with the anatomy of the arm.

Exploratory surgery without knowledge of the exact location of the implant is strongly discouraged.

2.4 Replacing IMPLANON

Immediate replacement can be done after removal of the previous implant and is similar to the insertion procedure described in section 2.2 Insertion of IMPLANON.

The new implant may be inserted in the same arm, and through the same incision from which the previous implant was removed. If the same incision is being used to insert a new implant, anesthetize the insertion site [for example, 2 mL lidocaine (1%)] applying it just under the skin along the 'insertion canal.'

Follow the subsequent steps in the insertion instructions [see Dosage and Administration (2.2)].
Remeron

Remeron

Initial Treatment

The recommended starting dose for REMERON (mirtazapine) Tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of REMERON in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for REMERON has not been adequately explored, patients not responding to the initial 15-mg dose may benefit from dose increases up to a maximum of 45 mg/day. REMERON has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should not be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.

Elderly and Patients with Renal or Hepatic Impairment

The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment (see PRECAUTIONS and CLINICAL PHARMACOLOGY).

Maintenance/Extended Treatment

It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of REMERON (mirtazapine) Tablets has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of REMERON needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with REMERON (mirtazapine) Tablets. Conversely, at least 14 days should be allowed after stopping REMERON before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of REMERON With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start REMERON in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with REMERON may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, REMERON should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with REMERON may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with REMERON is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

Discontinuation of Remeron Treatment

Symptoms associated with the discontinuation or dose reduction of REMERON Tablets have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction. A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response (see PRECAUTIONS and ADVERSE REACTIONS).

Information for Patients

Patients should be advised that taking REMERON can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Remeronsoltab

Remeronsoltab

Initial Treatment

The recommended starting dose for REMERONSolTab (mirtazapine) Orally Disintegrating Tablets is 15 mg/day, administered in a single dose, preferably in the evening prior to sleep. In the controlled clinical trials establishing the efficacy of REMERON in the treatment of major depressive disorder, the effective dose range was generally 15 to 45 mg/day. While the relationship between dose and satisfactory response in the treatment of major depressive disorder for REMERON has not been adequately explored, patients not responding to the initial 15-mg dose may benefit from dose increases up to a maximum of 45 mg/day. REMERON has an elimination half-life of approximately 20 to 40 hours; therefore, dose changes should not be made at intervals of less than 1 to 2 weeks in order to allow sufficient time for evaluation of the therapeutic response to a given dose.

Administration of REMERONSolTab (mirtazapine) Orally Disintegrating Tablets

Patients should be instructed to open tablet blister pack with dry hands and place the tablet on the tongue. The tablet should be used immediately after removal from its blister; once removed, it cannot be stored. REMERONSolTab (mirtazapine) Orally Disintegrating Tablets will disintegrate rapidly on the tongue and can be swallowed with saliva. No water is needed for taking the tablet. Patients should not attempt to split the tablet.

Elderly and Patients with Renal or Hepatic Impairment

The clearance of mirtazapine is reduced in elderly patients and in patients with moderate to severe renal or hepatic impairment. Consequently, the prescriber should be aware that plasma mirtazapine levels may be increased in these patient groups, compared to levels observed in younger adults without renal or hepatic impairment (see PRECAUTIONS and CLINICAL PHARMACOLOGY).

Maintenance/Extended Treatment

It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacological therapy beyond response to the acute episode. Systematic evaluation of REMERON (mirtazapine) Tablets has demonstrated that its efficacy in major depressive disorder is maintained for periods of up to 40 weeks following 8 to 12 weeks of initial treatment at a dose of 15 to 45 mg/day (see CLINICAL PHARMACOLOGY). Based on these limited data, it is unknown whether or not the dose of REMERON needed for maintenance treatment is identical to the dose needed to achieve an initial response. Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment.

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with REMERONSolTab Orally Disintegrating Tablets. Conversely, at least 14 days should be allowed after stopping REMERONSolTab before starting an MAOI intended to treat psychiatric disorders (see CONTRAINDICATIONS).

Use of REMERONSolTab With Other MAOIs, Such as Linezolid or Methylene Blue

Do not start REMERONSolTab in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see CONTRAINDICATIONS).

In some cases, a patient already receiving therapy with REMERONSolTab may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, REMERONSolTab should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with REMERONSolTab may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see WARNINGS).

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with REMERONSolTab is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see WARNINGS).

Discontinuation of Remeron Treatment

Symptoms associated with the discontinuation or dose reduction of REMERONSolTab Orally Disintegrating Tablets have been reported. Patients should be monitored for these and other symptoms when discontinuing treatment or during dosage reduction. A gradual reduction in the dose over several weeks, rather than abrupt cessation, is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, dose titration should be managed on the basis of the patient's clinical response (see PRECAUTIONS and ADVERSE REACTIONS).

Information for Patients

Patients should be advised that taking REMERONSolTab can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle-closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible.
Zemuron

Zemuron

ZEMURON is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. Doses of ZEMURON injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered.

The dosage information which follows is derived from studies based upon units of drug per unit of body weight. It is intended to serve as an initial guide to clinicians familiar with other neuromuscular blocking agents to acquire experience with ZEMURON.

In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration (2.5), Warnings and Precautions (5.9, 5.12), Drug Interactions (7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.10), and Use in Specific Populations (8.6)].

2.1 Dose for Tracheal Intubation

The recommended initial dose of ZEMURON, regardless of anesthetic technique, is 0.6 mg/kg. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1 (0.4-6) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 3 minutes. This dose may be expected to provide 31 (15-85) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Under halothane, isoflurane, and enflurane anesthesia, some extension of the period of clinical relaxation should be expected [see Drug Interactions (7.3)].

A lower dose of ZEMURON (0.45 mg/kg) may be used. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1.3 (0.8-6.2) minute(s), and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 4 minutes. This dose may be expected to provide 22 (12-31) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Patients receiving this low dose of 0.45 mg/kg who achieve less than 90% block (about 16% of these patients) may have a more rapid time to 25% recovery, 12 to 15 minutes.

A large bolus dose of 0.9 or 1.2 mg/kg can be administered under opioid/nitrous oxide/oxygen anesthesia without adverse effects to the cardiovascular system [see Clinical Pharmacology (12.2)].

2.2 Rapid Sequence Intubation

In appropriately premedicated and adequately anesthetized patients, ZEMURON 0.6 to 1.2 mg/kg will provide excellent or good intubating conditions in most patients in less than 2 minutes [see Clinical Studies (14.1)].

2.3 Maintenance Dosing

Maintenance doses of 0.1, 0.15, and 0.2 mg/kg ZEMURON, administered at 25% recovery of control T1 (defined as 3 twitches of train-of-four), provide a median (range) of 12 (2-31), 17 (6-50), and 24 (7-69) minutes of clinical duration under opioid/nitrous oxide/oxygen anesthesia [see Clinical Pharmacology (12.2)]. In all cases, dosing should be guided based on the clinical duration following initial dose or prior maintenance dose and not administered until recovery of neuromuscular function is evident. A clinically insignificant cumulation of effect with repetitive maintenance dosing has been observed [see Clinical Pharmacology (12.2)].

2.4 Use by Continuous Infusion

Infusion at an initial rate of 10 to 12 mcg/kg/min of ZEMURON should be initiated only after early evidence of spontaneous recovery from an intubating dose. Due to rapid redistribution [see Clinical Pharmacology (12.3)] and the associated rapid spontaneous recovery, initiation of the infusion after substantial return of neuromuscular function (more than 10% of control T1) may necessitate additional bolus doses to maintain adequate block for surgery.

Upon reaching the desired level of neuromuscular block, the infusion of ZEMURON must be individualized for each patient. The rate of administration should be adjusted according to the patient's twitch response as monitored with the use of a peripheral nerve stimulator. In clinical trials, infusion rates have ranged from 4 to 16 mcg/kg/min.

Inhalation anesthetics, particularly enflurane and isoflurane, may enhance the neuromuscular blocking action of nondepolarizing muscle relaxants. In the presence of steady-state concentrations of enflurane or isoflurane, it may be necessary to reduce the rate of infusion by 30% to 50%, at 45 to 60 minutes after the intubating dose.

Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of ZEMURON infusion may be expected to proceed at rates comparable to that following comparable total doses administered by repetitive bolus injections [see Clinical Pharmacology (12.2)].

Infusion solutions of ZEMURON can be prepared by mixing ZEMURON with an appropriate infusion solution such as 5% glucose in water or lactated Ringers [see Dosage and Administration (2.6)]. These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.

Infusion rates of ZEMURON can be individualized for each patient using the following tables for 3 different concentrations of ZEMURON solution as guidelines:
Table 1: Infusion Rates Using ZEMURON Injection (0.5 mg/mL)* Patient Weight Drug Delivery Rate (mcg/kg/min) (kg) (lbs) 4 5 6 7 8 9 10 12 14 16 Infusion Delivery Rate (mL/hr) * 50 mg ZEMURON in 100 mL solution. 10 22 4.8 6 7.2 8.4 9.6 10.8 12 14.4 16.8 19.2 15 33 7.2 9 10.8 12.6 14.4 16.2 18 21.6 25.2 28.8 20 44 9.6 12 14.4 16.8 19.2 21.6 24 28.8 33.6 38.4 25 55 12 15 18 21 24 27 30 36 42 48 35 77 16.8 21 25.2 29.4 33.6 37.8 42 50.4 58.8 67.2 50 110 24 30 36 42 48 54 60 72 84 96 60 132 28.8 36 43.2 50.4 57.6 64.8 72 86.4 100.8 115.2 70 154 33.6 42 50.4 58.8 67.2 75.6 84 100.8 117.6 134.4 80 176 38.4 48 57.6 67.2 76.8 86.4 96 115.2 134.4 153.6 90 198 43.2 54 64.8 75.6 86.4 97.2 108 129.6 151.2 172.8 100 220 48 60 72 84 96 108 120 144 168 192 Table 2: Infusion Rates Using ZEMURON Injection (1 mg/mL)* Patient Weight Drug Delivery Rate (mcg/kg/min) (kg) (lbs) 4 5 6 7 8 9 10 12 14 16 Infusion Delivery Rate (mL/hr) * 100 mg ZEMURON in 100 mL solution. 10 22 2.4 3 3.6 4.2 4.8 5.4 6 7.2 8.4 9.6 15 33 3.6 4.5 5.4 6.3 7.2 8.1 9 10.8 12.6 14.4 20 44 4.8 6 7.2 8.4 9.6 10.8 12 14.4 16.8 19.2 25 55 6 7.5 9 10.5 12 13.5 15 18 21 24 35 77 8.4 10.5 12.6 14.7 16.8 18.9 21 25.2 29.4 33.6 50 110 12 15 18 21 24 27 30 36 42 48 60 132 14.4 18 21.6 25.2 28.8 32.4 36 43.2 50.4 57.6 70 154 16.8 21 25.2 29.4 33.6 37.8 42 50.4 58.8 67.2 80 176 19.2 24 28.8 33.6 38.4 43.2 48 57.6 67.2 76.8 90 198 21.6 27 32.4 37.8 43.2 48.6 54 64.8 75.6 86.4 100 220 24 30 36 42 48 54 60 72 84 96 Table 3: Infusion Rates Using ZEMURON Injection (5 mg/mL)* Patient Weight Drug Delivery Rate (mcg/kg/min) (kg) (lbs) 4 5 6 7 8 9 10 12 14 16 Infusion Delivery Rate (mL/hr) * 500 mg ZEMURON in 100 mL solution. 10 22 0.5 0.6 0.7 0.8 1 1.1 1.2 1.4 1.7 1.9 15 33 0.7 0.9 1.1 1.3 1.4 1.6 1.8 2.2 2.5 2.9 20 44 1 1.2 1.4 1.7 1.9 2.2 2.4 2.9 3.4 3.8 25 55 1.2 1.5 1.8 2.1 2.4 2.7 3 3.6 4.2 4.8 35 77 1.7 2.1 2.5 2.9 3.4 3.8 4.2 5 5.9 6.7 50 110 2.4 3 3.6 4.2 4.8 5.4 6 7.2 8.4 9.6 60 132 2.9 3.6 4.3 5 5.8 6.5 7.2 8.6 10.1 11.5 70 154 3.4 4.2 5 5.9 6.7 7.6 8.4 10.1 11.8 13.4 80 176 3.8 4.8 5.8 6.7 7.7 8.6 9.6 11.5 13.4 15.4 90 198 4.3 5.4 6.5 7.6 8.6 9.7 10.8 13 15.1 17.3 100 220 4.8 6 7.2 8.4 9.6 10.8 12 14.4 16.8 19.2
2.5 Dosage in Specific Populations

Pediatric Patients: The recommended initial intubation dose of ZEMURON is 0.6 mg/kg; however, a lower dose of 0.45 mg/kg may be used depending on anesthetic technique and the age of the patient.

For sevoflurane (induction) ZEMURON doses of 0.45 mg/kg and 0.6 mg/kg in general produce excellent to good intubating conditions within 75 seconds. When halothane is used, a 0.6 mg/kg dose of ZEMURON resulted in excellent to good intubating conditions within 60 seconds.

The time to maximum block for an intubating dose was shortest in infants (28 days up to 3 months) and longest in neonates (birth to less than 28 days). The duration of clinical relaxation following an intubating dose is shortest in children (greater than 2 years up to 11 years) and longest in infants.

When sevoflurane is used for induction and isoflurane/nitrous oxide for maintenance of general anesthesia, maintenance dosing of ZEMURON can be administered as bolus doses of 0.15 mg/kg at reappearance of T3 in all pediatric age groups. Maintenance dosing can also be administered at the reappearance of T2 at a rate of 7 to 10 mcg/kg/min, with the lowest dose requirement for neonates (birth to less than 28 days) and the highest dose requirement for children (greater than 2 years up to 11 years).

When halothane is used for general anesthesia, patients ranging from 3 months old through adolescence can be administered ZEMURON maintenance doses of 0.075 to 0.125 mg/kg upon return of T1 to 0.25% to provide clinical relaxation for 7 to 10 minutes. Alternatively, a continuous infusion of ZEMURON initiated at a rate of 12 mcg/kg/min upon return of T1 to 10% (one twitch present in train-of-four) may also be used to maintain neuromuscular blockade in pediatric patients.

Additional information for administration to pediatric patients of all age groups is presented elsewhere in the label [see Clinical Pharmacology (12.2)].

The infusion of ZEMURON must be individualized for each patient. The rate of administration should be adjusted according to the patient's twitch response as monitored with the use of a peripheral nerve stimulator. Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of ZEMURON infusion may be expected to proceed at rates comparable to that following similar total exposure to single bolus doses [see Clinical Pharmacology (12.2)].

ZEMURON is not recommended for rapid sequence intubation in pediatric patients.

Geriatric Patients: Geriatric patients (65 years or older) exhibited a slightly prolonged median (range) clinical duration of 46 (22-73), 62 (49-75), and 94 (64-138) minutes under opioid/nitrous oxide/oxygen anesthesia following doses of 0.6, 0.9, and 1.2 mg/kg, respectively. No differences in duration of neuromuscular blockade following maintenance doses of ZEMURON were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.2) and Clinical Studies (14.2)]. [See also Warnings and Precautions (5.4).]

Patients with Renal or Hepatic Impairment: No differences from patients with normal hepatic and kidney function were observed for onset time at a dose of 0.6 mg/kg ZEMURON. When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1.5 times longer in patients with hepatic disease. Patients with renal failure may have a greater variation in duration of effect [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].

Obese Patients: In obese patients, the initial dose of ZEMURON 0.6 mg/kg should be based upon the patient's actual body weight [see Clinical Studies (14.1)].

An analysis across all US controlled clinical studies indicates that the pharmacodynamics of ZEMURON are not different between obese and nonobese patients when dosed based upon their actual body weight.

Patients with Reduced Plasma Cholinesterase Activity: Rocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity.

Patients with Prolonged Circulation Time: Because higher doses of ZEMURON produce a longer duration of action, the initial dosage should usually not be increased in these patients to reduce onset time; instead, in these situations, when feasible, more time should be allowed for the drug to achieve onset of effect [see Warnings and Precautions (5.7)].

Patients with Drugs or Conditions Causing Potentiation of Neuromuscular Block: The neuromuscular blocking action of ZEMURON is potentiated by isoflurane and enflurane anesthesia. Potentiation is minimal when administration of the recommended dose of ZEMURON occurs prior to the administration of these potent inhalation agents. The median clinical duration of a dose of 0.57 to 0.85 mg/kg was 34, 38, and 42 minutes under opioid/nitrous oxide/oxygen, enflurane and isoflurane maintenance anesthesia, respectively. During 1 to 2 hours of infusion, the infusion rate of ZEMURON required to maintain about 95% block was decreased by as much as 40% under enflurane and isoflurane anesthesia [see Drug Interactions (7.3)].

2.6 Preparation for Administration of ZEMURON

Diluent Compatibility: ZEMURON is compatible in solution with:
0.9% NaCl solution sterile water for injection 5% glucose in water lactated Ringers 5% glucose in saline
ZEMURON is compatible in the above solutions at concentrations up to 5 mg/mL for 24 hours at room temperature in plastic bags, glass bottles, and plastic syringe pumps.

Drug Admixture Incompatibility: ZEMURON is physically incompatible when mixed with the following drugs:
amphotericin hydrocortisone sodium succinate amoxicillin insulin azathioprine Intralipid cefazolin ketorolac cloxacillin lorazepam dexamethasone methohexital diazepam methylprednisolone erythromycin thiopental famotidine trimethoprim furosemide vancomycin
If ZEMURON is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of ZEMURON and drugs for which incompatibility with ZEMURON has been demonstrated or for which compatibility with ZEMURON has not been established.

Infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.

ZEMURON should not be mixed with alkaline solutions [see Warnings and Precautions (5.10)].

Visual Inspection: Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit. Do not use solution if particulate matter is present.
Cyclessa

Cyclessa

To achieve maximum contraceptive effectiveness, CYCLESSA® Tablets (desogestrel and ethinyl estradiol tablets USP) must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. CYCLESSA® may be initiated using either a Sunday start or a Day 1 start.

NOTE: Seven different "day label strips" are provided to accommodate the selected start regimen. The patient should place the self-adhesive "day label strip" that corresponds to her starting day on the blister card above the first row of tablets.

DURING THE FIRST CYCLE OF USE

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of CYCLESSA® should be considered. A woman can begin to take CYCLESSA® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, CYCLESSA® should be started on the same day that a new pack of the previous oral contraceptive would have been started.

SUNDAY START

When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking CYCLESSA® Tablets (desogestrel and ethinyl estradiol tablets USP).

Using a Sunday start, tablets are taken daily without interruption as follows: The first light yellow tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first light yellow tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the blister card. One light yellow tablet is taken daily for 7 days, followed by 1 orange tablet daily for 7 days, 1 red tablet daily for 7 days, and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green (inactive) tablet. [If switching from a Sunday Start oral contraceptive, the first CYCLESSA® tablet should be taken on the second Sunday after the last tablet of a 21 day oral contraceptive regimen or should be taken on the first Sunday after the last inactive tablet of a 28 day regimen.]

If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive red (active) tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should keep taking 1 active tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

DAY 1 START

Counting the first day of menstruation as "Day 1", the first light yellow tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One light yellow tablet daily for 7 days, then 1 orange tablet daily for 7 days, followed by 1 red tablet daily for 7 days and then 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green (inactive) tablet. [If switching directly from another oral contraceptive, the first light yellow tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]

If a patient misses 1 active tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive active tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive red tablets in the third week or misses 3 or more active tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS

If Spotting or Breakthrough Bleeding Occurs

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of CYCLESSA® in the Event of a Missed Menstrual Period
If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and CYCLESSA® use should be discontinued if pregnancy is confirmed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. CYCLESSA® should be discontinued if pregnancy is confirmed.
Use of CYCLESSA® Postpartum

The use of CYCLESSA® for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers").

If the patient starts on CYCLESSA® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a light yellow tablet has been taken daily for 7 consecutive days.
Desogen

Desogen

To achieve maximum contraceptive effectiveness, DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) must be taken exactly as directed, at the same time every day, and at intervals not exceeding 24 hours. DESOGEN® may be initiated using either a Sunday start or a Day 1 start.

NOTE: Seven different "day label strips" are provided to accommodate the selected start regimen. The patient should place the self-adhesive "day label strip" that corresponds to her starting day on the blister card above the first row of tablets.

DURING THE FIRST CYCLE OF USE

IMPORTANT: The possibility of ovulation and conception prior to initiation of use of DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) should be considered. A woman can begin to take DESOGEN® either on the first Sunday after the onset of her menstrual period (Sunday Start) or on the first day of her menstrual period (Day 1 Start). When switching from another oral contraceptive, DESOGEN® should be started on the same day that a new pack of the previous oral contraceptive would have been started.

SUNDAY START

When initiating a Sunday start regimen, another method of contraception, such as condoms or spermicide, should be used for the first 7 consecutive days of taking DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP).

Using a Sunday start, tablets are taken daily without interruption as follows: The first white tablet should be taken on the first Sunday after menstruation begins (if menstruation begins on Sunday, the first white tablet is taken on that day). Tablets are then taken sequentially following the arrows marked on the blister card. One white tablet is taken daily for 21 days, followed by 1 green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day (Sunday) after taking the last green (inactive) tablet. [If switching from a different Sunday Start oral contraceptive, the first DESOGEN® tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]

If a patient misses 1 white (active) tablet in Weeks 1, 2, or 3, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should keep taking 1 white tablet daily until the next Sunday. On Sunday the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

DAY 1 START

Counting the first day of menstruation as "Day 1", the first white tablet should be taken on the first day of menstrual bleeding. Tablets are then taken sequentially without interruption as follows: One white tablet daily for 21 days, then one green (inactive) tablet daily for 7 days. For all subsequent cycles, the patient then begins a new 28-tablet regimen on the next day after taking the last green (inactive) tablet. [If switching directly from another oral contraceptive, the first white tablet should be taken on the same day that a new pack of the previous oral contraceptive would have been started.]

If a patient misses 1 white tablet, she should take the missed tablet as soon as she remembers. If the patient misses 2 consecutive white tablets in Week 1 or Week 2, the patient should take 2 tablets the day she remembers and 2 tablets the next day; thereafter, the patient should resume taking 1 tablet daily until she finishes the cycle pack. The patient should be instructed to use a back-up method of birth control (such as condoms or spermicide) if she has intercourse in the 7 days after she restarts her pills. If the patient misses 2 consecutive white tablets in the third week or misses 3 or more white tablets in a row at any time during the cycle, the patient should throw out the rest of that cycle pack and start a new cycle pack that same day. The patient should be instructed to use a back-up method of birth control if she has intercourse in the 7 days after restarting her pills.

Complete instructions to facilitate patient counseling on proper pill usage can be found in Detailed or Brief Patient Labeling ("How to Take the Pill" section).

ADDITIONAL INSTRUCTIONS FOR BOTH SUNDAY AND DAY 1 STARTS

If Spotting or Breakthrough Bleeding Occurs

Breakthrough bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing oral contraceptives. In breakthrough bleeding, as in all cases of irregular bleeding from the vagina, non-functional causes should be considered. In undiagnosed persistent or recurrent abnormal bleeding from the vagina, adequate diagnostic measures are indicated to rule out pregnancy or malignancy. If both pregnancy and pathology have been excluded, time or a change to another preparation may solve the problem. Changing to an oral contraceptive with a higher estrogen content, while potentially useful in minimizing menstrual irregularity, should be done only if necessary since this may increase the risk of thromboembolic disease.

Use of DESOGEN® in the Event of a Missed Menstrual Period
If the patient has not adhered to the prescribed schedule, the possibility of pregnancy should be considered at the time of the first missed period and DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) use should be discontinued if pregnancy is confirmed. If the patient has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out. DESOGEN® should be discontinued if pregnancy is confirmed.
Use of DESOGEN® Postpartum

The use of DESOGEN® Tablets (desogestrel and ethinyl estradiol tablets USP) for contraception may be initiated 4 to 6 weeks postpartum in women who elect not to breast-feed. When the tablets are administered during the postpartum period, the increased risk of thromboembolic disease associated with the postpartum period must be considered (see CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See also PRECAUTIONS for "Nursing Mothers").

If the patient starts on DESOGEN® postpartum, and has not yet had a period, she should be instructed to use another method of contraception until a white tablet has been taken daily for 7 consecutive days.
Follistim Aq

Follistim Aq

2.1 General Dosing
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If the solution is not clear and colorless or has particles in it, the solution should not be used. Do not mix Follistim AQ with any other medicines in the same vial or in the same syringe.
2.2 Recommended Dosing for Ovulation Induction

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)].
A starting daily dose of 75 international units of Follistim AQ is administered for at least the first 7 days. Subsequent dosage adjustments are made at weekly intervals based upon ovarian response. If an increase in dose is indicated by the ovarian response, the increase should be made by 25 or 50 international units of Follistim AQ at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate ovarian response.
The following should be considered when planning the woman's individualized dose:
Appropriate Follistim AQ dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. The maximum, individualized, daily dose of Follistim AQ is 300 international units. Treatment should continue until ultrasonic visualizations and/or serum estradiol determinations approximate the pre-ovulatory conditions seen in normal individuals. When pre-ovulatory conditions are reached, 5000 to 10,000 international units of hCG are used to induce final oocyte maturation and ovulation.The administration of hCG must be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Follistim AQ therapy [see Warnings and Precautions (5.1, 5.2, 5.10)]. The woman and her partner should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent [see Warnings and Precautions (5.10)]. During treatment with Follistim AQ and during a two-week post-treatment period, the woman should be assessed at least every other day for signs of excessive ovarian stimulation.
It is recommended that Follistim AQ administration be stopped if the ovarian monitoring suggests an increased risk of OHSS or abdominal pain occurs. Most OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days post-ovulation.

2.3 Recommended Dosing for ART

The dosing scheme follows a stepwise approach and is individualized for each woman.
A starting dose of 150 to 225 international units of Follistim AQ is administered subcutaneously or intramuscularly daily for at least the first 4 days of treatment. Subsequent dosing beyond the first 4 days of treatment is adjusted based upon the woman's ovarian response as determined by ultrasound evaluation of follicular growth and serum estradiol levels.The following should be considered when planning the woman's individualized dose: For most normal responding women, the daily starting dose can be continued until pre-ovulatory conditions are achieved (six to twelve days). For low or poor responding women, the daily dose should be increased according to the ovarian response. The maximum, individualized, daily dose of Follistim AQ is 600 international units. For high responding women [those at particular risk of abnormal ovarian enlargement and/or ovarian hyperstimulation syndrome (OHSS)], decrease or temporarily stop the daily dose, or discontinue the cycle according to individual response [see Warnings and Precautions (5.1, 5.2, 5.10)]. When a sufficient number of follicles of adequate size are present, dosing of Follistim AQ is stopped and final maturation of the oocytes is induced by administering hCG at a dose of 5000 to 10,000 international units. The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Follistim AQ therapy [see Warnings and Precautions (5.1, 5.2, 5.10)]. Oocyte (egg) retrieval should be performed 34 to 36 hours following the administration of hCG.
2.4 Recommended Dosing for Induction of Spermatogenesis in Men
Pretreatment with hCG is required prior to concomitant therapy with Follistim AQ and hCG. An initial dosage of 1500 international units of hCG should be administered at twice weekly intervals to normalize serum testosterone levels. If serum testosterone levels have not normalized after 8 weeks of hCG treatment, the hCG dose can be increased to 3000 international units twice weekly [see Clinical Studies (14.3)]. After normal serum testosterone levels have been reached, Follistim AQ should be administered by subcutaneous injection concomitantly with hCG treatment. Follistim AQ should be given at a dosage of 450 international units per week, as either 225 international units twice weekly or 150 international units three times per week, in combination with the same hCG dose used to normalize testosterone levels.
The concomitant therapy should be continued for at least 3 to 4 months before any improvement in spermatogenesis can be expected. If a man has not responded after this period, the combination therapy may be continued. Treatment response has been noted at up to 12 months.
Bcg Vaccine

Bcg Vaccine

Preparation of Agent

The preparation of the BCG VACCINE suspension should be done using aseptic technique. To avoid cross-contamination, parenteral drugs should not be prepared in areas where BCG VACCINE has been prepared. A separate area for the preparation of the BCG VACCINE suspension is recommended. All equipment, supplies and receptacles in contact with BCG VACCINE should be handled and disposed of as biohazardous. The pharmacist or individual responsible for mixing the agent should wear gloves, and take precautions to avoid contact of BCG with broken skin. If preparation cannot be performed in a biocontainment hood, then a mask and gown should be worn to avoid inhalation of BCG organisms and inadvertent exposure to broken skin.

Using aseptic methods, 1 mL of Sterile Water for Injection, USP at 4-25°C (39-77°F), is added to one vial of vaccine (see Pediatric Dose below for pediatric use). Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria.

Persons administering vaccines should take necessary precautions to minimize risk for spreading disease. Hands should be washed before each new patient is seen. Syringes and needles used for applications must be sterile and preferably disposable to minimize the risk of contamination. A separate needle and syringe should be used for each application. Disposable needles and the multiple puncture device should be discarded as biohazardous waste in labeled, puncture-proof containers to prevent inadvertent needlestick injury or reuse.{22} After use, any unused vaccine and all materials exposed to the product should be immediately placed in a biohazard container and disposed of in an appropriate manner.

Reconstituted vaccine should be kept refrigerated, protected from exposure to direct sunlight, and used within 2 hours. Freezing of the reconstituted product is not recommended.

Note: DO NOT filter the contents of the BCG VACCINE vial. Precautions should be taken to avoid exposing the BCG VACCINE to direct sunlight. Bacteriostatic solutions must be avoided. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Reconstitution should result in a uniform suspension of the bacilli.

Treatment and Schedule

BCG vaccination is reserved for persons who have a reaction of less than 5mm induration after skin testing with 5 TU of PPD tuberculin. The preferred method of skin testing is the Mantoux tuberculin skin-test using 0.1 mL of 5 tuberculin units (TU) of PPD.{3} It is recommended that a Mantoux skin-test be performed prior to BCG vaccination to demonstrate the absence of tuberculous infection.

The vaccine is to be administered after fully explaining the risks and benefits to the vaccinee, parent, or guardian. BCG vaccination should not be given to individuals previously infected with M. tuberculosis. The vaccine is administered percutaneously utilizing a sterile multiple puncture device. The multiple puncture device consists of a plastic holder for a thin, wafer-like stainless steel plate 7/8" by 1 1/8", from which 36 points protrude. After the vaccine is prepared, the skin site is cleansed with an alcohol or acetone sponge and allowed to dry thoroughly.
1. Administer the vaccine in the deltoid region (Figure 1). Position the arm to maintain a horizontal surface where the vaccine is to be placed.
Figure 1
2. Drop the immunizing dose of 0.2–0.3 mL of BCG VACCINE from the syringe and needle onto the cleansed surface of the skin (Figure 2) and spread over a 1" by 2" area using the edge of the multiple puncture device (Figure 3).
Figure 2

Figure 3
3. Grasp the arm firmly from underneath, tensing the skin. Center the multiple puncture device over the vaccine and apply firm downward pressure such that the device points are well buried in the skin (Figure 4).
Figure 4
4. Maintain pressure for 5 seconds. Do not "rock" the device. Release the pressure underneath the arm and remove the device. In a successful procedure the points puncture the skin. If the points do not puncture the skin, the procedure must be repeated. 5. After successful puncture, spread vaccine as evenly as possible over the puncture area with the edge of the device. An additional 1–2 drops of BCG VACCINE may be added to ensure a very wet vaccination site. 6. Use the multiple puncture device once and discard in a standard biohazardous sharps container. 7. Loosely cover the site and keep dry for 24 hours. 8. Advise the patient that the vaccine contains live organisms. Although the vaccine will not survive in a dry state for long, infection of others is possible.
Tuberculin reactivity resulting from BCG vaccination should be documented. A vaccinated person should be tuberculin skin tested 2–3 months after BCG administration, and the test results, in millimeters of induration, should be recorded in the person's medical record.{9} Vaccination should be repeated for those who remain tuberculin negative to 5 TU of tuberculin after 2–3 months.

Pediatric Dose

Do not administer INTRAVENOUSLY, SUBCUTANEOUSLY, INTRAMUSCULARLY, OR INTRADERMALLY. Administer the vaccine in the deltoid region.

In infants less than 1 month old, the dosage of BCG VACCINE should be reduced by one-half, by using 2 mL of Sterile Water for Injection, USP at 4-25°C (39-77°F) when reconstituting. If a vaccinated infant remains tuberculin negative to 5 TU on skin testing, and if indications for vaccination persist, the infant should receive a full dose after 1 year of age.

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