Emd Serono, Inc.

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Emd Serono, Inc. Drugs

Serophene

Serophene

General Considerations

The workup and treatment of candidates for clomiPHENE citrate therapy should be supervised by physicians experienced in management of gynecologic or endocrine disorders. Patients should be chosen for therapy with clomiPHENE citrate only after careful diagnostic evaluation (see INDICATIONS AND USAGE). The plan of therapy should be outlined in advance. Impediments to achieving the goal of therapy must be excluded or adequately treated before beginning clomiPHENE citrate. The therapeutic objective should be balanced with potential risks and discussed with the patient and others involved in the achievement of a pregnancy.

Ovulation most often occurs from 5 to 10 days after a course of clomiPHENE citrate. Coitus should be timed to coincide with the expected time of ovulation. Appropriate tests to determine ovulation may be useful during this time.

Recommended Dosage

Treatment of the selected patient should begin with a low dose, 50 mg daily (1 tablet) for 5 days. The dose should be increased only in those patients who do not ovulate in response to cyclic 50 mg clomiPHENE citrate. A low dosage or duration of treatment course is particularly recommended if unusual sensitivity to pituitary gonadotropin is suspected, such as in patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome).

The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.

If progestin-induced bleeding is planned, or if spontaneous uterine bleeding occurs prior to therapy, the regimen of 50 mg daily for 5 days should be started on or about the 5th day of the cycle. Therapy may be started at any time in the patient who has had no recent uterine bleeding. When ovulation occurs at this dosage, there is no advantage to increasing the dose in subsequent cycles of treatment.

If ovulation does not appear to occur after the first course of therapy, a second course of 100 mg daily (two 50 mg tablets given as a single daily dose) for 5 days should be given. This course may be started as early as 30 days after the previous one after precautions are taken to exclude the presence of pregnancy. Increasing the dosage or duration of therapy beyond 100 mg/day for 5 days is not recommended.

The majority of patients who are going to ovulate will do so after the first course of therapy. If ovulation does not occur after three courses of therapy, further treatment with clomiPHENE citrate is not recommended and the patient should be reevaluated. If three ovulatory responses occur, but pregnancy has not been achieved, further treatment is not recommended. If menses does not occur after an ovulatory response, the patient should be reevaluated. Long-term cyclic therapy is not recommended beyond a total of about six cycles (see PRECAUTIONS).
Zorbtive

Zorbtive

Zorbtive® should be administered to patients with short bowel syndrome (SBS) at a dose of approximately 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily. Administration for more than 4 weeks has not been adequately studied.

Injections should be administered daily for 4 weeks. Changes to concomitant medications should be avoided. Patients and physicians should monitor for adverse events. Treat moderate fluid retention and arthralgias symptomatically or dose reduce by 50%. Discontinue Zorbtive® for up to 5 days for severe toxicities. Upon resolution of symptoms, resume at 50% of original dose. Permanently discontinue treatment if severe toxicity recurs or does not disappear within 5 days.

Injection sites should be rotated.

Safety and effectiveness in pediatric patients with short bowel syndrome have not been established.

Each vial of Zorbtive® 8.8 mg is reconstituted in 1 to 2 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol). See Table 4 below for expected concentration after reconstitution. Approximately 10% mechanical loss can be associated with reconstitution and administration from multi-dose vials. For patients sensitive to Benzyl Alcohol, see “WARNINGS”.
Table 4: Expected Concentration After Reconstitution (mg/mL) 1 mL 2 mL 8.8 mg 8.8 4.4
To reconstitute Zorbtive®, inject the diluent into the vial of Zorbtive® aiming the liquid against the glass vial wall. Swirl the vial with a gentle rotary motion until contents are dissolved completely. The Zorbtive® solution should be clear immediately after reconstitution. DO NOT INJECT Zorbtive® if the reconstituted product is cloudy immediately after reconstitution or after refrigeration. The reconstituted Zorbtive® 8.8 mg can be refrigerated (2-8oC/36-46oF) for up to 14 days. Occasionally, after refrigeration, small colorless particles may be present in the Zorbtive® 8.8 mg solution. This is not unusual for proteins like Zorbtive®. Allow refrigerated solution to come to room temperature prior to administration. A standard insulin-type subcutaneous syringe is recommended for administration.

STABILITY AND STORAGE

Before Reconstitution: Vials of Zorbtive® and diluent should be stored at room temperature, (15-30°C/59-86°F). Expiration dates are stated on product labels.

After Reconstitution with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol. The reconstituted solution should be stored under refrigeration (2-8oC/36-46oF) for up to 14 days. Avoid freezing reconstituted vials of Zorbtive®.
Egrifta

Egrifta

2.1 Dosing Information

The recommended dose of EGRIFTA® is 2 mg injected subcutaneously once a day.

The recommended injection site is the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.

2.2 Reconstitution Instructions

Instructions for reconstituting EGRIFTA® are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the EGRIFTA® medication box and in the injection box.

If not used immediately, the reconstituted EGRIFTA® solution should be discarded. Do not freeze or refrigerate the reconstituted EGRIFTA® solution.

Reconstituted EGRIFTA® solution should always be inspected visually for particulate matter and discoloration prior to administration. EGRIFTA® must be injected only if the solution is clear, colorless and without particulate matter.
Stay Awake

Stay Awake

2.1 Dosing Information

The recommended dose of REBIF is either 22 mcg or 44 mcg injected subcutaneously three times per week. REBIF should be administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days (e.g., Monday, Wednesday, and Friday) at least 48 hours apart each week.

Generally, patients should be started at 20% of the prescribed dose three times per week and increased over a 4-week period to the targeted dose, either 22 mcg three times per week (see Table 1) or 44 mcg three times per week (see Table 2). Patients prescribed a targeted dose of 22 mcg three times per week should use the prefilled syringes for titration.

A Titration Pack containing 6 doses of 8.8 mcg (0.2 mL) and 6 doses of 22 mcg (0.5 mL) is available for use during the titration period in both REBIF prefilled syringes and REBIF Rebidose autoinjectors.
Table 1: Titration Schedule for a 22 mcg Prescribed Dose* Week of Use Dose Syringe to Use Amount of syringe * Use only prefilled syringes, not autoinjectors, to titrate to the 22 mcg Prescribed Dose Week 1 Titration 4.4 mcg 8.8 mcg syringe Use half of syringe Week 2 Titration 4.4 mcg 8.8 mcg syringe Use half of syringe Week 3 Titration 11 mcg 22 mcg syringe Use half of syringe Week 4 Titration 11 mcg 22 mcg syringe Use half of syringe Week 5 and after 22 mcg 22 mcg syringe or autoinjector Use full syringe or autoinjector Table 2: Titration Schedule for a 44 mcg Prescribed Dose* Week of Use Dose Syringe or Autoinjector to Use Amount of syringe or autoinjector * Prefilled syringes or autoinjectors can be used to titrate to the 44 mcg Prescribed Dose Week 1 Titration 8.8 mcg 8.8 mcg syringe or autoinjector Use full syringe or autoinjector Week 2 Titration 8.8 mcg 8.8 mcg syringe or autoinjector Use full syringe or autoinjector Week 3 Titration 22 mcg 22 mcg syringe or autoinjector Use full syringe or autoinjector Week 4 Titration 22 mcg 22 mcg syringe or autoinjector Use full syringe or autoinjector Week 5 and after 44 mcg 44 mcg syringe or autoinjector Use full syringe or autoinjector
Decreased peripheral blood counts or elevated liver function tests may necessitate dose reduction or discontinuation of REBIF administration until toxicity is resolved [see Warnings and Precautions (5.2, 5.5) and Adverse Reactions (6)].

2.2 Important Administration Instructions

REBIF is intended for use under the guidance and supervision of a physician. It is recommended that physicians or qualified medical personnel train patients in the proper technique for self-administering subcutaneous injections using the prefilled syringe or injection device approved for use with REBIF. Injection depth of the REBIF Rebidose autoinjector is fixed at 8 mm; the health care provider should determine the injection technique.

The initial injection should be performed under the supervision of an appropriately qualified health care provider.

Appropriate instruction for self-injection or injection by another person should be provided to the patient or their caregiver, including careful review of the REBIF Medication Guide and the REBIF Rebidose autoinjector Instructions for Use that accompanies the product. Users should demonstrate competency in all aspects of the injection prior to independent use. If a patient is to self-administer REBIF, the physical and cognitive ability of that patient to self-administer and properly dispose of prefilled syringes or the REBIF Rebidose autoinjectors should be assessed. Patients with severe neurological deficits should not self-administer injections without assistance from a trained caregiver.

Advise patients and caregivers to:
visually inspect REBIF for particulate matter and discoloration prior to administration use aseptic technique when administering REBIF rotate site of injection with each dose to minimize the likelihood of severe injection site reactions or necrosis [see Warnings and Precautions, (5.4)] use a puncture-resistant container for safe disposal of used needles, prefilled syringes and REBIF Rebidose autoinjectors do not re-use needles, syringes or REBIF Rebidose autoinjectors
2.3 Premedication for Flu-like Symptoms

Concurrent use of analgesics and/or antipyretics may help ameliorate flu-like symptoms associated with REBIF use on treatment days.
Luveris

Luveris

For Subcutaneous Use Only

Dosage

It is recommended that 75 IU Luveris® be concomitantly administered subcutaneously with 75 IU to 150 IU Gonal-f® as two separate injections in the initial treatment cycle. Concomitant administration of Luveris® with Gonal-f® was studied in the clinical trials for Luveris®. The safety and effectiveness of concomitant administration of Luveris® with any other preparation of recombinant human FSH or urinary human FSH is unknown. Luveris® and Gonal-f® should be administered daily until adequate follicular development is indicated by ovary ultrasonography and serum estradiol. Treatment duration should not normally exceed 14 days unless signs of imminent follicular development are present.

To complete follicular development and effect ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) should be given one day after the last dose of Luveris® and Gonal-f®. Treatment with hCG should be withheld if the ovaries are abnormally enlarged or if excessive estradiol production has occurred. If the ovaries are abnormally enlarged or abdominal pain occurs, treatment with Luveris® and Gonal-f® should be discontinued and hCG should not be administered, and the patient should be advised not to have intercourse; this may reduce the chances of developing Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chances of multiple gestation. A follow-up visit should be conducted in the luteal phase.

Doses administered in subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses of Gonal-f® greater than 225 IU per day are not routinely recommended. As in the initial cycle, hCG must be given to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of developing Ovarian Hyperstimulation Syndrome.

The couple should be encouraged to have intercourse daily, beginning on the day prior to hCG administration until ovulation becomes apparent in the indices used for the determination of progestational activity.

In light of the indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not prescribe Luveris®.

Administration:

Dissolve the contents of one vial of Luveris® in 1 mL Sterile Water for Injection, USP. Gonal-f® should be reconstituted and administered as directed in the prescriber labeling for this product. Administer entire contents of each vial SUBCUTANEOUSLY as separate injections. For single use. Use immediately after reconstitution. Any unused reconstituted material should be discarded. Mix gently. Do not shake.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

Directions for Administration of Luveris®:

Luveris® and Gonal-f® may be self-administered by the patient. Follow the directions below for reconstituting and injecting as separate injections of Luveris® and Gonal-f®. Gonal-f® should be reconstituted and administered as directed in the prescriber labeling for this product. Any unused reconstituted material should be discarded.

Step 1: Prepare the vials

Wash your hands thoroughly with soap and water.

Begin by opening the carton of Luveris®. Remove the plastic flip-tops from the vial of Luveris® powder and the vial of diluent provided with Luveris®. After removing the plastic flip-tops with your thumb, wipe the rubber stoppers with alcohol. The rubber stoppers should not be touched after they are wiped.

Step 2: Withdraw the Water into the Syringe

Carefully remove the needle cover. Do not touch the needle or allow the needle to touch any surface. After removing the needle cover, draw air into the syringe by slowly pulling back the plunger to the 1 cc mark. Place the vial of diluent on a hard, flat surface. Carefully insert the needle through the rubber stopper into the vial with the sterile water (diluent).

Gently inject the air into the vial (the injected air creates pressure, which makes withdrawing the solution easier). Without removing the needle, turn the vial upside down and withdraw all of the water into the syringe, making sure the tip of the needle remains in the water. Remove the needle from the vial.

Step 3: Inject the Water into the Luveris® Vial

Place the vial containing the Luveris® powder on a hard, fl at surface. Insert the needle through the rubber stopper into the vial. Keep the syringe in a straight, upright position as you insert it through the center of the rubber stopper, or it may be difficult to depress the plunger. After inserting the needle, slowly inject the sterile water (diluent) by depressing the plunger on the syringe into the vial of Luveris® powder.

Step 4: Gently Dissolve the Luveris® Powder

Leaving the needle in the vial, gently rotate the vial between your fingers until all of the powder is dissolved. Do not shake. Check that the solution is clear and colorless. Do not use if the solution is cloudy, discolored, or contains particles.

Step 5: Withdraw the Luveris® solution from the Vial

Without removing the needle, turn the vial upside down and withdraw all of the Luveris® solution into the syringe. Make sure the tip of the needle remains in the solution by slowly backing the needle out of the vial to withdraw as much of the solution as possible. Next, remove the needle from the vial.

Step 6: Replace needle and remove air bubbles in the syringe

Recap the syringe needle and twist the cap and needle off of syringe. Twist a new needle onto the end of the syringe and carefully remove the cap of the needle. To remove any air bubbles in the syringe, point the needle up and gently tap the syringe. When all the bubbles float to the top, slightly push the plunger until a small drop or two of solution begins to appear from the tip of the needle.

Step 7: Recap the syringe needle

Recap the syringe needle. Do not touch the needle or allow the needle to touch any surface. Carefully lay the syringe down on a flat, clean surface.

Step 8: Carefully clean the injection site

Suitable injection sites on the stomach (a few inches above or below the navel) will be advised by your fertility specialist. Occasionally your fertility specialist may suggest an alternative site. Make yourself comfortable by sitting or lying down. Carefully clean the injection site with an alcohol wipe and allow it to air-dry.

Step 9: Administer your injection

Remove the needle cap from the syringe needle. Hold the syringe like a pencil. With your other hand, pinch the skin together. Using a dart-like motion, insert the needle at a 45° to 90° angle (just under the skin) into the pad of tissue as shown or as directed by your doctor, nurse, or pharmacist. Do not inject into a vein.

Release the hand pinching the skin and depress the plunger in a slow, steady motion until all the medication is injected.

Step 10: Gently withdraw the needle

Withdraw the needle.

Step 11: Storage and clean up

Discard the used needle and syringe into your safety container. Place gauze over the injection site. If any bleeding occurs, apply gentle pressure. If bleeding does not stop within a few minutes, place a clean piece of gauze over the injection site and cover it with an adhesive bandage. Remember that your injection materials must be kept sterile and cannot be reused.
Egrifta

Egrifta

2.1 General Dosing Information

The recommended dose of EGRIFTA® is 2 mg injected subcutaneously once a day.

The recommended injection site is the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.

2.2 Reconstitution Procedure

EGRIFTA® must be reconstituted with the diluent provided with the product.

Reconstitute the 2 mg vial of EGRIFTA® with 2.1 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake.

Detailed instructions for reconstituting EGRIFTA® are provided in the INSTRUCTIONS FOR USE leaflet enclosed in the boxes containing EGRIFTA® and diluent.

Administer EGRIFTA® immediately following reconstitution and throw away any unused EGRIFTA® solution. If not used immediately, the reconstituted EGRIFTA® solution should be discarded. Do not freeze or refrigerate the reconstituted EGRIFTA® solution.

2.3 Administration

Reconstituted EGRIFTA® solution should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. EGRIFTA® must be injected only if the solution is clear, colorless and without particulate matter.

EGRIFTA® should be injected subcutaneously into the skin on the abdomen. Injection sites should be rotated to different areas of the abdomen. Do not inject into scar tissue, bruises or the navel.
Gonal-f

Gonal-f

Each Gonal-f® Multi-Dose Vial delivers 450 IU or 1050 IU follitropin alfa, respectively.

Dosage

Infertile Patients with oligo-anovulation

The dose of Gonal-f® (follitropin alfa for injection) to stimulate development of the follicle must be individualized for each patient.

The lowest dose consistent with the expectation of good results should be used. Over the course of treatment, doses of Gonal-f® may range up to 300 IU per day depending on the individual patient response. Gonal-f® should be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. A response is generally evident after 5 to 7 days. Subsequent monitoring intervals should be based on individual patient response.

It is recommended that the initial dose of the first cycle be 75 IU of Gonal-f® per day, ADMINISTERED SUBCUTANEOUSLY. An incremental adjustment in dose of up to 37.5 IU may be considered after 14 days. Further dose increases of the same magnitude could be made, if necessary, every seven days. Treatment duration should not exceed 35 days unless an E2 rise indicates imminent follicular development. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, chorionic gonadotropin, hCG, (5,000 USP units) should be given 1 day after the last dose of Gonal-f®. Chorionic gonadotropin should be withheld if the serum estradiol is greater than 2,000 pg/mL. If the ovaries are abnormally enlarged or abdominal pain occurs, Gonal-f® treatment should be discontinued, hCG should not be administered, and the patient should be advised not to have intercourse; this may reduce the chance of development of the Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chance of multiple gestation. A follow-up visit should be conducted in the luteal phase.

The initial dose administered in the subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses larger than 300 IU of FSH per day are not routinely recommended. As in the initial cycle, 5,000 USP units of hCG must be given 1 day after the last dose of Gonal-f® to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of development of the Ovarian Hyperstimulation Syndrome.

The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. Care should be taken to ensure insemination. In light of the indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not use Gonal-f®.

Assisted Reproductive Technologies

As in the treatment of patients with oligo-anovulatory infertility, the dose of Gonal-f® to stimulate development of the follicle must be individualized for each patient. For Assisted Reproductive Technologies, therapy with Gonal-f® should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of 150 IU per day, until sufficient follicular development is attained. In most cases, therapy should not exceed ten days.

In patients undergoing ART, whose endogenous gonadotropin levels are suppressed, Gonal-f® should be initiated at a dose of 225 IU per day. Treatment should be continued until adequate follicular development is indicated as determined by ultrasound in combination with measurement of serum estradiol levels. Adjustments to dose may be considered after five days based on the patient's response; subsequently dosage should be adjusted no more frequently than every 3-5 days and by no more than 75-150 IU additionally at each adjustment. Doses greater than 450 IU per day are not recommended. Once adequate follicular development is evident, hCG (5,000 to 10,000 USP units) should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.

Male Patients with Hypogonadotropic Hypogonadism

The dose of Gonal-f® (follitropin alfa for injection) to induce spermatogenesis must be individualized for each patient. Gonal-f® must be given in conjunction with hCG. Prior to concomitant therapy with Gonal-f® and hCG, pretreatment with hCG alone (1,000 to 2,250 USP units two to three times per week) is required. Treatment should continue for a period sufficient to achieve serum testosterone levels within the normal range. Such pretreatment may require 3 to 6 months and the dose of hCG may need to be increased to achieve normal serum testosterone levels. After normal serum testosterone levels are reached, the recommended dose of Gonal-f® is 150 IU administered subcutaneously three times a week and the recommended dose of hCG is 1,000 USP units (or the dose required to maintain serum testosterone levels within the normal range) three times a week. The lowest dose of Gonal-f® which induces spermatogenesis should be utilized. If azoospermia persists, the dose of Gonal-f® may be increased to a maximum dose of 300 IU three times per week. Gonal-f® may need to be administered for up to 18 months to achieve adequate spermatogenesis.

Administration

Multi-Dose 450 IU Vial

Dissolve the contents of one Multi-Dose vial (450 IU) with 1 mL Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP. Resulting concentration will be 600 IU/mL. Following reconstitution as directed, product will deliver the equivalent of six 75 IU doses.

Multi-Dose 1050 IU Vial

Dissolve the contents of one Multi-Dose vial (1050 IU) with 2 mL Bacteriostatic Water for Injection (0.9% benzyl alcohol), USP. Resulting concentration will be 600 IU/mL. Following reconstitution as directed, product will deliver the equivalent of fourteen 75 IU doses.

Patients should be instructed to use the accompanying syringes, calibrated in FSH units (IU FSH) for administration. The 27-gauge injection syringe (see figure below) has unit dose markings from 37.5 IU to 600 IU FSH for use with Gonal-f® Multi-Dose. Patients should be instructed to take a specific dose of Gonal-f® Multi-Dose. The doctor, nurse, or pharmacist should show the patient how to locate the syringe marking that corresponds to the prescribed dose.

Patient Instructions for Use for Gonal-f® Multi-Dose Vial

Step 1: Mixing (reconstituting) Gonal-f® Multi-Dose Vial
Wash your hands with soap and water. Using your thumb, flip off the plastic cap of the Gonal-f® Multi-Dose vial. Wipe the top of the vial stopper with an alcohol swab. Carefully twist the needle cap off the syringe labeled 'Bacteriostatic Water for Injection, USP'. Do not touch the needle or allow the needle to touch any surface. Position the needle of the syringe of water in a straight, upright position over the marked center circle of the rubber stopper on the vial of Gonal-f® Multi-Dose powder. Keep the needle in a straight, upright position as you insert it through the center circle, or it may be difficult to depress the plunger. Slowly inject the water into the vial by depressing the syringe plunger. When all the water has been injected into the vial, withdraw the needle and safely dispose of it immediately in your needle container. Do not use this needle to inject your dose. Do not shake the vial. If bubbles appear, wait a few moments for the bubbles to settle. The liquid drug should be clear.
Step 2: Preparing the Dose
Wipe the rubber stopper of the vial of Gonal-f® Multi-Dose liquid with an alcohol wipe. Carefully pull the cap from the needle. Do not touch the needle or allow the needle to touch any surface. Firmly hold the vial of Gonal-f® Multi-Dose liquid on a flat surface, insert the needle through the marked center circle of the rubber stopper. Keeping the needle in the vial, lift the vial and turn it upside down with the needle pointing toward the ceiling. With the needle tip in the liquid, slowly pull back the plunger until the syringe fills to slightly more than the mark for your prescribed dose. Next, keeping the needle in the vial, slowly adjust the plunger to your prescribed dose – this will clear away any air bubbles. Check that you have the plunger set at your prescribed dose. Remove the syringe needle from the vial. Inject the prescribed dose as directed by the doctor.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Gonal-f Rff Pen

Gonal-f Rff Pen

The Gonal-f® RFF Pen delivery system delivers at least 300 IU, 450 IU, or 900 IU, equivalent to a maximum of four 75 IU injections, six 75 IU injections or twelve 75 IU injections, respectively. The minimum dose that can be set is 37.5 IU; the maximum dose that can be set is 300 IU (for 300 IU delivery system) or 450 IU (for 450 IU and 900 IU delivery system).

Dosage

Infertile Patients with Oligo-Anovulation

The dose of Gonal-f® RFF Pen (follitropin alfa injection) to stimulate development of the follicle must be individualized for each patient.

The lowest dose consistent with the expectation of good results should be used. Over the course of treatment, doses of Gonal-f® RFF Pen may range up to 300 IU per day depending on the individual patient response. Gonal-f® RFF Pen should be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. A response is generally evident after 5 to 7 days. Subsequent monitoring intervals should be based on individual patient response.

It is recommended that the initial dose of the first cycle be 75 IU of Gonal-f® RFF Pen per day, administered subcutaneously. An incremental adjustment in dose of up to 37.5 IU may be considered after 14 days. Further dose increases of the same magnitude could be made, if necessary, every seven days. Treatment duration should not exceed 35 days unless an E2 rise indicates imminent follicular development. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, chorionic gonadotropin, hCG, should be given after the last dose of Gonal-f® RFF Pen. Chorionic gonadotropin should be withheld if the serum estradiol is greater than 2,000 pg/mL. If the ovaries are abnormally enlarged or abdominal pain occurs, Gonal-f® RFF Pen treatment should be discontinued, hCG should not be administered, and the patient should be advised not to have intercourse; this may reduce the chance of development of the Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chance of multiple gestation. A follow-up visit should be conducted in the luteal phase.

The initial dose administered in the subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses larger than 300 IU of FSH per day are not routinely recommended. As in the initial cycle, hCG must be given after the last dose of Gonal-f® RFF Pen to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of development of the Ovarian Hyperstimulation Syndrome.

The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. Care should be taken to ensure insemination. In light of the indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/ she should not use Gonal-f® RFF Pen.

Assisted Reproductive Technologies

As in the treatment of patients with oligo-anovulatory infertility, the dose of Gonal-f® RFF Pen to stimulate development of the follicle must be individualized for each patient. For Assisted Reproductive Technologies, therapy with Gonal-f® RFF Pen should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of 150 IU per day administered subcutaneously, until sufficient follicular development is attained. In most cases, therapy should not exceed ten days.

In patients undergoing ART under 35 years old, whose endogenous gonadotropin levels are suppressed, Gonal-f® RFF Pen should be initiated at a dose of 150 IU per day. In patients 35 years old and older whose endogenous gonadotropin levels are suppressed, Gonal-f® RFF Pen should be initiated at a dose of 225 IU per day. Treatment should be continued until adequate follicular development is indicated as determined by ultrasound in combination with measurement of serum estradiol levels. Adjustments to dose may be considered after five days based on the patient's response; subsequently dosage should be adjusted no more frequently than every 3-5 days and by no more than 75-150 IU additionally at each adjustment. Doses greater than 450 IU per day are not recommended. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.

Administration

Administer subcutaneously in the abdomen as described in the 'Patient's Information Leaflet' provided for patients prescribed Gonal-f® RFF Pen.
Gonal-f Rff

Gonal-f Rff

Each Gonal-f® RFF single-dose vial delivers 75 IU follitropin alfa.

Dosage

Infertile Patients with oligo-anovulation

The dose of Gonal-f® RFF (follitropin alfa for injection) to stimulate development of the follicle must be individualized for each patient.

The lowest dose consistent with the expectation of good results should be used. Over the course of treatment, doses of Gonal-f® RFF may range up to 300 IU per day depending on the individual patient response. Gonal-f® RFF should be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. A response is generally evident after 5 to 7 days. Subsequent monitoring intervals should be based on individual patient response.

It is recommended that the initial dose of the first cycle be 75 IU of Gonal-f® RFF per day, ADMINISTERED SUBCUTANEOUSLY. An incremental adjustment in dose of up to 37.5 IU may be considered after 14 days. Further dose increases of the same magnitude could be made, if necessary, every seven days. Treatment duration should not exceed 35 days unless an E2 rise indicates imminent follicular development. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, chorionic gonadotropin, hCG, should be given after the last dose of Gonal-f® RFF. Chorionic gonadotropin should be withheld if the serum estradiol is greater than 2,000 pg/mL. If the ovaries are abnormally enlarged or abdominal pain occurs, Gonal-f® RFF treatment should be discontinued, hCG should not be administered, and the patient should be advised not to have intercourse; this may reduce the chance of development of the Ovarian Hyperstimulation Syndrome and, should spontaneous ovulation occur, reduce the chance of multiple gestation. A follow-up visit should be conducted in the luteal phase.

The initial dose administered in the subsequent cycles should be individualized for each patient based on her response in the preceding cycle. Doses larger than 300 IU of FSH per day are not routinely recommended. As in the initial cycle, hCG must be given after the last dose of Gonal-f® RFF to complete follicular development and induce ovulation. The precautions described above should be followed to minimize the chance of development of the Ovarian Hyperstimulation Syndrome.

The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. Care should be taken to ensure insemination. In light of the indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not use Gonal-f® RFF.

Assisted Reproductive Technologies

As in the treatment of patients with oligo-anovulatory infertility, the dose of Gonal-f® RFF to stimulate development of the follicle must be individualized for each patient. For Assisted Reproductive Technologies, therapy with Gonal-f® RFF should be initiated in the early follicular phase (cycle day 2 or 3) at a dose of 150 IU per day, until sufficient follicular development is attained. In most cases, therapy should not exceed ten days. In patients undergoing ART under 35 years old, whose endogenous gonadotropin levels are suppressed, Gonal-f® RFF should be initiated at a dose of 150 IU per day. In patients 35 years old and older whose endogenous gonadotropin levels are suppressed, Gonal-f® RFF should be initiated at a dose of 225 IU per day. Treatment should be continued until adequate follicular development is indicated as determined by ultrasound in combination with measurement of serum estradiol levels. Adjustments to dose may be considered after five days based on the patient's response; subsequently dosage should be adjusted no more frequently than every 3-5 days and by no more than 75-150 IU additionally at each adjustment. Doses greater than 450 IU per day are not recommended. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.

Administration

Dissolve the contents of one or more single-dose vials of Gonal-f® RFF in 1.0 mL of Sterile Water for Injection, USP (concentration should not exceed 450 IU/mL) and ADMINISTER SUBCUTANEOUSLY immediately. Any unused reconstituted material should be discarded.
Cetrotide

Cetrotide

Ovarian stimulation therapy with gonadotropins (FSH, hMG) is started on cycle Day 2 or 3. The dose of gonadotropins should be adjusted according to individual response. Cetrotide® (cetrorelix acetate for injection) 0.25 mg may be administered subcutaneously once daily during the early- to mid-follicular phase.

Cetrotide® 0.25 mg is administered on either stimulation day 5 (morning or evening) or day 6 (morning) and continued daily until the day of hCG administration.

When assessment by ultrasound shows a sufficient number of follicles of adequate size, hCG is administered to induce ovulation and final maturation of the oocytes. No hCG should be administered if the ovaries show an excessive response to the treatment with gonadotropins to reduce the chance of developing ovarian hyperstimulation syndrome (OHSS).

Administration

Cetrotide® 0.25 mg can be administered by the patient herself after appropriate instructions by her doctor.

Directions for using Cetrotide® 0.25 mg with the enclosed needles and pre-filled syringe:
Wash hands thoroughly with soap and water. Flip off the plastic cover of the vial and wipe the aluminum ring and the rubber stopper with an alcohol swab. Twist the injection needle with the yellow mark (20 gauge) on the pre-filled syringe. Push the needle through the center of the rubber stopper of the vial and slowly inject the solvent into the vial. Leaving the syringe in the vial, gently swirl the vial until the solution is clear and without residues. Avoid forming bubbles. Draw the total contents of the vial into the syringe. If necessary, invert the vial and pull back the needle as far as needed to withdraw the entire contents of the vial. Replace the needle with the yellow mark by the injection needle with the grey mark (27 gauge). Invert the syringe and push the plunger until all air bubbles have been expelled. Choose an injection site in the lower abdominal area, preferably around, but staying at least one inch away from the navel. Choose a different injection site each day to minimize local irritation. Use the second alcohol swab to clean the skin at the injection site and allow alcohol to dry. Gently pinch up the skin surrounding the site of injection. Inject the prescribed dose as directed by your doctor, nurse or pharmacist. Use the syringe and needles only once. Dispose of the syringe and needles properly after use. If available, use a medical waste container for disposal.
Saizen

Saizen

For subcutaneous injection.

Saizen® therapy should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency or adult patients with either childhood-onset or adult-onset growth hormone deficiency.

2.1 Pediatric Growth Hormone Deficiency (GHD)

Saizen® dosage and administration schedule should be individualized for each patient. The recommended weekly dosage is 0.18 mg/kg of body weight by subcutaneous injection. It should be divided into equal doses given either on 3 alternate days, 6 times per week or daily.

Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and evaluation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human growth hormone.

Treatment with Saizen® of growth failure due to growth hormone deficiency should be discontinued when the epiphyses are fused.

2.2 Adult Growth Hormone Deficiency (GHD)

Either of two approaches to Saizen® dosing may be followed: a weight-based regimen or a non-weight-based regimen.

Weight-based

Based on the dosing utilized in the original pivotal study described herein, the recommended dosage at the start of therapy is not more than 0.005 mg/kg given as a daily subcutaneous injection. The dosage may be increased to not more than 0.01 mg/kg/day after 4 weeks according to individual patient requirements. Clinical response, side effects, and determination of age-and gender-adjusted serum insulin-like growth factor (IGF-1) levels may be used as guidance in dose titration.

Non-weight-based

Alternatively, taking into account more recent literature, a starting dose of approximately 0.2 mg/day (range, 0.15-0.30 mg/day) may be used without consideration of body weight. This dose can be increased gradually every 1 to 2 months by increments of approximately 0.1 to 0.2 mg/day, according to individual patient requirements based on the clinical response and serum IGF-1 concentrations. During therapy, the dose should be decreased if required by the occurrence of adverse reactions and/or serum IGF-1 levels above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person.

A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen. In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women.

2.3 Preparation and Administration

Vials

To prevent possible contamination, wipe the rubber vial stopper with an antiseptic solution before puncturing it with the needle. It is recommended that Saizen® be administered using sterile, disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be drawn from the vial with reasonable accuracy.

After determining the appropriate patient dose, reconstitute each vial of Saizen® as follows: 5 mg vial with 1 to 3 mL of Bacteriostatic Water for Injection, USP (Benzyl Alcohol preserved); 8.8 mg vial with 2-3 mL of Bacteriostatic Water for Injection, USP (Benzyl Alcohol preserved). Approximately 10% mechanical loss can be associated with reconstitution and multidose administration.

If sensitivity to the diluent occurs, Saizen® may be reconstituted with Sterile Water for Injection, USP. When Saizen® is reconstituted in this manner, the reconstituted solution should be used immediately and any unused solution should be discarded [see Warnings and Precautions (5.15)].

To reconstitute Saizen®, inject the diluent into the vial of Saizen® aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. SAIZEN MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

click.easy® cartridges

For drug preparation instructions for Saizen® click.easy® cartridges, please refer to the instructions for use provided with click.easy® reconstitution device.
Gonal-f Rff Redi-ject

Gonal-f Rff Redi-ject

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. Gonal-f® RFF Redi-ject™ is a pre-filled disposable auto-injection device intended for multiple dose use. Gonal-f® RFF Redi-ject™ can be set in 12.5 International Units increments. Administer Gonal-f® RFF Redi-ject™ subcutaneously in the abdomen as described in Instructions for Use Do not attempt to mix any other medications inside of the device with Gonal-f® RFF Redi-ject™. Instruct women to remove the Gonal-f® RFF Redi-ject™ from the refrigerator at least 30 minutes prior to use in order to allow Gonal-f® RFF Redi-ject™ to warm to room temperature and avoid the discomfort of a cold injection.
2.2 Recommended Dosing for Ovulation Induction

The dosing scheme is stepwise and is individualized for each woman [see Clinical Studies (14.1)]. Starting doses less than 37.5 International Units have not been studied in clinical trials and are not recommended.
A starting daily dose of 75 International Units of Gonal-f® RFF Redi-ject™ is administered subcutaneously daily for 14 days in the first cycle of use.
In subsequent cycles of treatment, the starting dose (and dosage adjustments) of Gonal-f® RFF Redi-ject™ should be determined based on the history of the ovarian response to Gonal-f® RFF Redi-ject™.
The following should be considered when planning the woman's individualized dose: - Appropriate Gonal-f ® RFF Redi-ject™ dose adjustment(s) should be used to prevent multiple follicular growth and cycle cancellation. - The maximum, individualized, daily dose of Gonal-f ® RFF Redi-ject™ is 300 International Units per day. - In general, do not exceed 35 days of treatment. If indicated by the ovarian response after the initial 14 days, make an incremental adjustment in dose, up to 37.5 International Units. If indicated by the ovarian response, make additional incremental adjustments in dose, up to 37.5 International Units, every 7 days. Treatment should continue until follicular growth and/or serum estradiol levels indicate an adequate ovarian response. When pre-ovulatory conditions are reached, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.
Withhold hCG in cases where the ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS) on the last day of Gonal-f® RFF Redi-ject™ therapy [see Warnings and Precautions (5.2, 5.3, 5.11)].
Encourage the woman and her partner to have intercourse daily, beginning on the day prior to the administration of hCG and until ovulation becomes apparent.
Discourage intercourse when the risk for OHSS is increased [see Warnings and Precautions (5.2, 5.3)].

2.3 Recommended Dosing for Assisted Reproductive Technology

The dosing scheme follows a stepwise approach and is individualized for each woman.
Beginning on cycle day 2 or 3, a starting dose of 150 International Units of Gonal-f® RFF Redi-ject™ is administered subcutaneously daily until sufficient follicular development, as determined by ultrasound in combination with measurement of serum estradiol levels, is attained. In most cases, therapy should not exceed 10 days. In women under 35 years of age whose endogenous gonadotropin levels are suppressed, initiate Gonal-f® RFF Redi-ject™ administration at a dose of 150 International Units per day. In women 35 years of age and older whose endogenous gonadotropin levels are suppressed, initiate Gonal-f® RFF Redi-ject™ administration at a dose of 225 International Units per day. Adjust the dose after 5 days based on the woman's ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels. Do not make additional dosage adjustments more frequently than every 3-5 days or by more than 75-150 International Units at each adjustment. Continue treatment until adequate follicular development is evident, and then administer hCG. The administration of hCG should be withheld in cases where the ovarian monitoring suggests an increased risk of OHSS on the last day of Gonal-f® RFF Redi-ject™ therapy [see Warnings and Precautions (5.2, 5.3, 5.11)]. Doses greater than 450 International Units per day are not recommended.
Motion Sickness

Motion Sickness

Serostim® is administered by subcutaneous injection.

Serostim® therapy should be carried out under the regular guidance of a physician who is experienced in the diagnosis and management of HIV infection.

2.1 HIV-associated wasting or cachexia

The usual starting dose of Serostim® is 0.1 mg/kg subcutaneously once daily (up to a total dose of 6 mg). Serostim® should be administered subcutaneously once daily at bedtime according to the following body weight-based dosage recommendations:
Weight Range Dose * Based on an approximate daily dosage of 0.1 mg/kg. >55kg (>121 lb) 6 mg* SC daily 45-55 kg (99-121 lb) 5 mg* SC daily 35-45 kg (75-99 lb) 4 mg* SC daily <35 kg (<75 lb) 0.1 mg/kg SC daily
Treatment with Serostim® 0.1 mg/kg every other day was associated with fewer side effects, and resulted in a similar improvement in work output, as compared with Serostim® 0.1 mg/kg daily. Therefore, a starting dose of Serostim® 0.1 mg/kg every other day should be considered in patients at increased risk for adverse effects related to recombinant human growth hormone therapy (i.e., glucose intolerance). In general, dose reductions (i.e., reducing the total daily dose or the number of doses per week) should be considered for side effects potentially related to recombinant human growth hormone therapy.

Most of the effect of Serostim® on work output and lean body mass was apparent after 12 weeks of treatment. The effect was maintained during an additional 12 weeks of therapy. There are no safety or efficacy data available from controlled studies in which patients were treated with Serostim® continuously for more than 48 weeks. There are no safety or efficacy data available from trials in which patients with HIV wasting or cachexia were treated intermittently with Serostim®.

2.2 Preparation and Administration

Each vial of Serostim® 5 mg or 6 mg is reconstituted with 0.5 to 1 mL Sterile Water for Injection, USP.

Each vial of Serostim® 4 mg is reconstituted in 0.5 to 1 mL of Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved). For patients sensitive to Benzyl Alcohol, Serostim® may be reconstituted with Sterile Water for Injection, USP [see Pediatric Use (8.4)].

When Serostim® is reconstituted with Sterile Water for Injection, USP, the reconstituted solution should be used immediately and any unused portion should be discarded.

When Serostim® is reconstituted with Bacteriostatic Water for Injection, USP (0.9% Benzyl Alcohol preserved) the reconstituted solution may be refrigerated (2-8°C/36-46°F) for up to 14 days.

Approximately 10% mechanical loss can be associated with reconstitution and administration from multi-dose vials.

To reconstitute Serostim®, inject the diluent into the vial of Serostim® aiming the liquid against the glass vial wall. Swirl the vial with a GENTLE rotary motion until contents are dissolved completely. DO NOT SHAKE. Parenteral drug products should always be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. SEROSTIM® MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. Use it only if it is clear and colorless.

Serostim® can be administered using (1) a standard sterile, disposable syringe and needle, (2) a compatible Serostim® needle-free injection device or (3) a compatible Serostim® needle injection device. For proper use, refer to the Instructions for Use provided with the administration device.

Injection sites, which may be located on the thigh, upper arm, abdomen or buttock, should be rotated to avoid local irritation.

Emd Serono, Inc.

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