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The dosages of ARICEPT® shown to be effective in controlled clinical trials are 5 mg and 10 mg administered once per day.
The higher dose of 10 mg did not provide a statistically significantly greater clinical benefit than 5 mg. There is a suggestion, however, based upon order of group mean scores and dose trend analyses of data from these clinical trials, that a daily dose of 10 mg of ARICEPT® might provide additional benefit for some patients. Accordingly, whether or not to employ a dose of 10 mg is a matter of prescriber and patient preference.
Evidence from the controlled trials indicates that the 10 mg dose, with a one week titration, is likely to be associated with a higher incidence of cholinergic adverse events than the 5 mg dose. In open label trials using a 6 week titration, the frequency of these same adverse events was similar between the 5 mg and 10 mg dose groups. Therefore, because steady state is not achieved for 15 days and because the incidence of untoward effects may be influenced by the rate of dose escalation, treatment with a dose of 10 mg should not be contemplated until patients have been on a daily dose of 5 mg for 4 to 6 weeks.
Each teaspoon (5 mL) of ARICEPT® Oral Solution contains a 5 mg dose. Patients should be instructed as to how to measure their dose of ARICEPT® Oral Solution in teaspoons.
ARICEPT® Oral Solution should be taken in the evening, just prior to retiring.
ARICEPT® Oral Solution can be taken with or without food.
2.1 Recommended Dosing
Dosage for Adults - one 0.5 mg capsule administered approximately one hour prior to the start of chemotherapy. ALOXI can be taken with or without food.
Regardless of the indication, the starting dose in patients with moderate hepatic impairment should be 5 mg twice daily, followed by adjustment based on therapeutic response and tolerability. Patients with mild hepatic insufficiency do not require dosage reductions. The use of pilocarpine in patients with severe hepatic insufficiency is not recommended. If needed, refer to the Hepatic Insufficiency subsection of the Precautions section of this label for definitions of mild, moderate and severe hepatic impairment.
Head & Neck Cancer Patients: The recommended initial dose of SALAGEN® Tablets is 5 mg taken three times a day. Dosage should be titrated according to therapeutic response and tolerance. The usual dosage range is up to 15-30 mg per day. (Not to exceed 10 mg per dose.) Although early improvement may be realized, at least 12 weeks of uninterrupted therapy with SALAGEN® Tablets may be necessary to assess whether a beneficial response will be achieved. The incidence of the most common adverse events increases with dose. The lowest dose that is tolerated and effective should be used for maintenance.
Sjogren's Syndrome Patients: The recommended dose of SALAGEN® Tablets is 5 mg taken four times a day. Efficacy was established by 6 weeks of use.
Each GLIADEL® Wafer contains 7.7 mg of carmustine, resulting in a dose of 61.6 mg when eight wafers are implanted. It is recommended that eight wafers be placed in the resection cavity if the size and shape of it allows. Should the size and shape not accommodate eight wafers, the maximum number of wafers as allowed should be placed. Since there is no clinical experience, no more than eight wafers should be used per surgical procedure.
Handling and Disposal1-7: Wafers should only be handled by personnel wearing surgical gloves because exposure to carmustine can cause severe burning and hyperpigmentation of the skin. Use of double gloves is recommended and the outer gloves should be discarded into a biohazard waste container after use. A surgical instrument dedicated to the handling of the wafers should be used for wafer implantation. If repeat neurosurgical intervention is indicated, any wafer or wafer remnant should be handled as a potentially cytotoxic agent.
GLIADEL® Wafer should be handled with care. The aluminum foil laminate pouches containing GLIADEL® Wafer should be delivered to the operating room and remain unopened until ready to implant the wafers. The outside surface of the outer foil pouch is not sterile.
Instructions for Opening Pouch Containing GLIADEL® Wafer
Figure 1: To remove the sterile inner pouch from the outer pouch, locate the folded corner and slowly pull in an outward motion.
Figure 2: Do NOT pull in a downward motion rolling knuckles over the pouch. This may exert pressure on the wafer and cause it to break.
Figure 3: Remove the inner pouch by grabbing hold of the crimped edge and pulling upward.
Figure 4: To open the inner pouch, gently hold the crimped edge and cut in an arc-like fashion around the wafer.
Figure 5: To remove the GLIADEL® Wafer, gently grasp the wafer with the aid of forceps and place it onto a designated sterile field.
Once the tumor is resected, tumor pathology is confirmed, and hemostasis is obtained, up to eight GLIADEL® Wafers (polifeprosan 20 with carmustine implant) may be placed to cover as much of the resection cavity as possible. Slight overlapping of the wafers is acceptable. Wafers broken in half may be used, but wafers broken in more than two pieces should be discarded in a biohazard container. Oxidized regenerated cellulose (Surgicel®) may be placed over the wafers to secure them against the cavity surface. After placement of the wafers, the resection cavity should be irrigated and the dura closed in a water tight fashion.
Unopened foil pouches may be kept at ambient room temperature for a maximum of six hours at a time.
HEXALEN® capsules is administered orally. Doses are calculated on the basis of body surface area.
HEXALEN® capsules may be administered either for 14 or 21 consecutive days in a 28 day cycle at a dose of 260 mg/m2/day. The total daily dose should be given as 4 divided oral doses after meals and at bedtime. There is no pharmacokinetic information supporting this dosing regimen and the effect of food on HEXALEN® capsules bioavailability or pharmacokinetics has not been evaluated.
HEXALEN® capsules should be temporarily discontinued (for 14 days or longer) and subsequently restarted at 200 mg/m2/day for any of the following situations: 1) Gastrointestinal intolerance unresponsive to symptomatic measures; 2) White blood count <2000/mm3 or granulocyte count <1000/mm3; 3) Platelet count <75,000/mm3; 4) Progressive neurotoxicity.
If neurologic symptoms fail to stabilize on the reduced dose schedule, HEXALEN® capsules should be discontinued indefinitely.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published (2-9). There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.
2.1 Recommended Dose
The recommended daily dose of LENVIMA is 24 mg (two 10 mg capsules and one 4 mg capsule) orally taken once daily with or without food [see Clinical Pharmacology (12.3)]. Continue LENVIMA until disease progression or until unacceptable toxicity occurs.
Take LENVIMA at the same time each day. If a dose is missed and cannot be taken within 12 hours, skip that dose and take the next dose at the usual time of administration.
Severe Renal or Hepatic Impairment
The recommended dose of LENVIMA is 14 mg taken orally once daily in patients with severe renal impairment (creatinine clearance [CLcr] less than 30 mL/min calculated by the Cockroft-Gault equation) or severe hepatic impairment (Child-Pugh C) [see Warning and Precaution (5.3), Use in Specific Populations (8.6, 8.7)].
2.2 Dose Modifications
HypertensionAssess blood pressure prior to and periodically during treatment. Initiate or adjust medical management to control blood pressure prior to and during treatment. Withhold LENVIMA for Grade 3 hypertension that persists despite optimal antihypertensive therapy; resume at a reduced dose (see Table 1) when hypertension is controlled at less than or equal to Grade 2. Discontinue LENVIMA for life-threatening hypertension.
Cardiac dysfunction or hemorrhageDiscontinue for a Grade 4 event. Withhold LENVIMA for development of Grade 3 event until improved to Grade 0 or 1 or baseline. Either resume at a reduced dose (see Table 1) or discontinue LENVIMA depending on the severity and persistence of the adverse event.
Arterial thrombotic eventDiscontinue LENVIMA following an arterial thrombotic event.
Renal failure and impairment or hepatotoxicityWithhold LENVIMA for development of Grade 3 or 4 renal failure/impairment or hepatotoxicity until resolved to Grade 0 to 1 or baseline. Either resume at a reduced dose (see Table 1) or discontinue LENVIMA depending on the severity and persistence of renal impairment or hepatotoxicity. Discontinue LENVIMA for hepatic failure.
ProteinuriaWithhold LENVIMA for ≥2 grams of proteinuria/24 hours. Resume at a reduced dose (see Table 1) when proteinuria is <2 gm/24 hours. Discontinue LENVIMA for nephrotic syndrome.
Gastrointestinal perforation or fistula formationDiscontinue LENVIMA in patients who develop gastrointestinal perforation or life-threatening fistula.
QT prolongationWithhold LENVIMA for the development of Grade 3 or greater QT interval prolongation. Resume LENVIMA at a reduced dose (see Table 1) when QT prolongation resolves to Grade 0 or 1 or baseline.
Reversible posterior leukoencephalopathy syndrome (RPLS)Withhold for RPLS until fully resolved. Upon resolution, resume at a reduced dose or discontinue LENVIMA depending on the severity and persistence of neurologic symptoms.
Manage other adverse reactions according to the instructions in Table 1. Based on the absence of clinical experience, there are no recommendations on resumption of dosing in patients with Grade 4 clinical adverse reactions that resolve.Table 1 Recommended Dose Modifications for Persistent and Intolerable Grade 2 or Grade 3 Adverse Reactions or Grade 4 Laboratory Abnormalitiesa Adverse Reaction Modification Adjusted Doseb First occurrence Interrupt until resolved to Grade 0-1 or baseline 20 mg (two 10 mg capsules) orally once daily Second occurrencec Interrupt until resolved to Grade 0-1 or baseline 14 mg (one 10 mg capsule plus one 4 mg capsule) orally once daily Third occurrencec Interrupt until resolved to Grade 0-1 or baseline 10 mg (one 10 mg capsule) orally once daily a Initiate medical management for nausea, vomiting, or diarrhea prior to interruption or dose reduction of LENVIMAb Reduce dose in succession based on the previous dose level (24 mg, 20 mg, or 14 mg per day)c Refers to the same or a different adverse reaction that requires dose modification
2.1 Dosing GuidelinesAdminister LUSEDRA intravenously as a bolus injection. Use supplemental oxygen for all patients undergoing sedation with LUSEDRA. Individualize the dosage of LUSEDRA and titrate to the level of sedation required for the procedure. In adults aged 18 to <65 years who are healthy or have mild systemic disease as categorized by the American Society of Anesthesiologists (ASA P1 or P2), the standard dosing regimen of LUSEDRA should be followed [see Standard Dosing Regimen for Sedation (2.2)]. In adults who are ≥ 65 years of age or who have severe systemic disease (ASA P3 or P4), the modified dosing regimen should be followed [see Modified Dosing Regimen for Sedation in Patients ≥ 65 years or Those with Severe Systemic Disease (2.3)]. Administer supplemental doses of LUSEDRA based on the patient's level of sedation and the level of sedation required for the procedure. Give supplemental doses only when patients can demonstrate purposeful movement in response to verbal or light tactile stimulation and no more frequently than every 4 minutes. Use only the minimum dosage required to facilitate the procedure. Consider the potential for worsened cardiorespiratory depression prior to using LUSEDRA concomitantly with other drugs that have the same potential (e.g., sedative-hypnotics or narcotic analgesics) [see Warnings and Precautions (5.2, 5.3)]. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg intravenously) was administered five minutes prior to the initial dose of LUSEDRA.
2.2 Standard Dosing Regimen for Sedation
In adults aged 18 to <65 years who are healthy or have mild systemic disease (ASA P1 or P2)1, the standard dosing regimen of LUSEDRA is an initial intravenous bolus of 6.5 mg/kg followed by supplemental doses of 1.6 mg/kg intravenously (25% of initial dosage) as needed to achieve the desired level of sedation as shown in Table 1.
The dosage of LUSEDRA is limited by lower and upper weight bounds of 60 kg and 90 kg. Adults who weigh >90 kg should be dosed as if they weigh 90 kg. No initial dose should exceed 16.5 mL; no supplemental dose should exceed 4 mL. Adults who weigh <60 kg should be dosed as if they weigh 60 kg. Dosages lower than those specified for the lower weight limit may be used to achieve lesser levels of sedation. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered five minutes prior to the initial dose of LUSEDRA.Table 1. Standard Dosing Regimen, Adults 18 to <65 Years of Age Who are Healthy or Have Mild Systemic Disease (ASA P1 or P2) Initial Dose Supplemental Dose No more frequently than every 4 min. Weight (kg) mg mL mg mL Note: Doses in this table are rounded to the nearest half-milliliter volume to facilitate practical measurement; hence, they may differ slightly from the dose recommended on the basis of mg/kg. ≤60 385 11 105 3 61 to 63 402.5 11.5 105 3 64 to 65 420 12 105 3 66 to 68 437.5 12.5 105 3 69 to 71 455 13 105 3 72 to 74 472.5 13.5 122.5 3.5 75 to 76 490 14 122.5 3.5 77 to 79 507.5 14.5 122.5 3.5 80 to 82 525 15 140 4 83 to 84 542.5 15.5 140 4 85 to 87 560 16 140 4 88 to 89 577.5 16.5 140 4 ≥90 577.5 16.5 140 4
2.3 Modified Dosing Regimen for Sedation in Patients ≥65 years or Those with Severe Systemic Disease (ASA P3 or P4)
Adults ≥65 years of age or those with severe systemic disease (ASA P3 or P4)1 should receive initial and supplemental intravenous dosages of 75% of the standard dosing regimen, as presented in Table 2. LUSEDRA is administered intravenously as a bolus injection. In clinical studies, an opioid premedication (fentanyl citrate 50 mcg IV) was administered five minutes prior to the initial dose of LUSEDRA.Table 2. Modified Dosing Regimen, Ages ≥ 65 Years Or Those with Severe Systemic Disease (ASA P3 or P4) Initial Dose Supplemental Dose No more frequently than every 4 min. Weight (kg) mg mL mg mL Note: Doses in this table are rounded to the nearest half-milliliter volume to facilitate practical measurement; hence, they may differ slightly from the dose recommended on the basis of mg/kg. ≤60 297.5 8.5 70 2 61 to 62 297.5 8.5 70 2 63 to 64 315 9 87.5 2.5 65 to 66 315 9 87.5 2.5 67 to 69 332.5 9.5 87.5 2.5 70 to 73 350 10 87.5 2.5 74 to 77 367.5 10.5 87.5 2.5 78 to 80 385 11 105 3 81 to 84 402.5 11.5 105 3 85 to 87 420 12 105 3 88 to 89 437.5 12.5 105 3 ≥90 437.5 12.5 105 3
LUSEDRA is provided as a ready to use formulation intended for single-patient use only. Prepare LUSEDRA following strict aseptic techniques. Draw LUSEDRA into sterile syringes immediately after vials are opened. Discard any unused portion at the end of the procedure.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if there is evidence of particulate matter or discoloration.
LUSEDRA has been shown to be compatible with the following fluids:5% Dextrose Injection, USP 5% Dextrose and 0.2% Sodium Chloride, USP 5% Dextrose and 0.45% Sodium Chloride Injection, USP 0.9% Sodium Chloride Injection, USP Lactated Ringer's Injection, USP Lactated Ringer's and 5% Dextrose Injection, USP 0.45% Sodium Chloride Injection, USP 5% Dextrose, 0.45% NaCl and 20 mEq KCl, USP
Do not mix LUSEDRA with other drugs or fluids prior to administration. LUSEDRA is not physically compatible with midazolam HCl or meperidine HCl, and compatibility with other agents has not been adequately evaluated.
Administer LUSEDRA through a secure, freely flowing, peripheral intravenous line using commonly available intravenous administration sets. Flush the infusion line with normal saline before and after administration of LUSEDRA.
LUSEDRA is not light sensitive. LUSEDRA does not need to be filtered before use.
The recommended initial dose of Targretin capsules is 300 mg/m2/day. (See Table 4.) Targretin capsules should be taken as a single oral daily dose with a meal. See CONTRAINDICATIONS: Pregnancy: Category X section for precautions to prevent pregnancy and birth defects in women of child-bearing potential.Table 4. Targretin Capsule Initial Dose Calculation According to Body Surface Area Initial Dose Level (300 mg/m2/day) Number of 75 mg Targretin Capsules Body Surface Area (m2) Total Daily Dose (mg/day) 0.88 - 1.12 300 4 1.13 - 1.37 375 5 1.38 - 1.62 450 6 1.63 - 1.87 525 7 1.88 - 2.12 600 8 2.13 - 2.37 675 9 2.38 - 2.62 750 10
Dose Modification Guidelines: The 300 mg/m2/day dose level of Targretin capsules may be adjusted to 200 mg/m2/day then to 100 mg/m2/day, or temporarily suspended, if necessitated by toxicity. When toxicity is controlled, doses may be carefully readjusted upward. If there is no tumor response after eight weeks of treatment and if the initial dose of 300 mg/m2/day is well tolerated, the dose may be escalated to 400 mg/m2/day with careful monitoring.
Duration of Therapy: In clinical trials in CTCL, Targretin capsules were administered for up to 97 weeks.
Targretin capsules should be continued as long as the patient is deriving benefit.
ZONEGRAN (zonisamide) is recommended as adjunctive therapy for the treatment of partial seizures in adults. Safety and efficacy in pediatric patients below the age of 16 have not been established. ZONEGRAN should be administered once or twice daily, using 25 mg or 100 mg capsules. ZONEGRAN is given orally and can be taken with or without food. Capsules should be swallowed whole.
Adults over Age 16:
The prescriber should be aware that, because of the long half-life of zonisamide, up to two weeks may be required to achieve steady state levels upon reaching a stable dose or following dosage adjustment. Although the regimen described below is one that has been shown to be tolerated, the prescriber may wish to prolong the duration of treatment at the lower doses in order to fully assess the effects of zonisamide at steady state, noting that many of the side effects of zonisamide are more frequent at doses of 300 mg per day and above. Although there is some evidence of greater response at doses above 100-200 mg/day, the increase appears small and formal dose-response studies have not been conducted.
The initial dose of ZONEGRAN should be 100 mg daily. After two weeks, the dose may be increased to 200 mg/day for at least two weeks. It can be increased to 300 mg/day and 400 mg/day, with the dose stable for at least two weeks to achieve steady state at each level. Evidence from controlled trials suggests that ZONEGRAN doses of 100-600 mg/day are effective, but there is no suggestion of increasing response above 400 mg/day (see CLINICAL PHARMACOLOGY, Clinical Studies subsection). There is little experience with doses greater than 600 mg/day.
Patients with Renal or Hepatic Disease:
Because zonisamide is metabolized in the liver and excreted by the kidneys, patients with renal or hepatic disease should be treated with caution, and might require slower titration and more frequent monitoring (see CLINICAL PHARMACOLOGY and PRECAUTIONS).
Panretin® gel should initially be applied two (2) times a day to cutaneous KS lesions. The application frequency can be gradually increased to three (3) or four (4) times a day according to individual lesion tolerance. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside.
Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry for three to five minutes before covering with clothing. Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel on or near mucosal surfaces of the body.
A response of KS lesions may be seen as soon as two weeks after initiation of therapy but most patients require longer application. With continued application, further benefit may be attained. Some patients have required over 14 weeks to respond. In clinical trials, Panretin® gel was applied for up to 96 weeks. Panretin® gel should be continued as long as the patient is deriving benefit.
Occlusive dressings should not be used with Panretin® gel.
Targretin® gel should be initially applied once every other day for the first week. The application frequency should be increased at weekly intervals to once daily, then twice daily, then three times daily and finally four times daily according to individual lesion tolerance. Generally, patients were able to maintain a dosing frequency of two to four times per day. Most responses were seen at dosing frequencies of two times per day and higher. If application site toxicity occurs, the application frequency can be reduced. Should severe irritation occur, application of drug can be temporarily discontinued for a few days until the symptoms subside. See CONTRAINDICATIONS: Pregnancy: Category X.
Sufficient gel should be applied to cover the lesion with a generous coating. The gel should be allowed to dry before covering with clothing. Because unaffected skin may become irritated, application of the gel to normal skin surrounding the lesions should be avoided. In addition, do not apply the gel near mucosal surfaces of the body.
A response may be seen as soon as four weeks after initiation of therapy but most patients require longer application. With continued application, further benefit may be attained. The longest onset time for the first response among the responders was 392 days based on the Composite Assessment of Index Lesion Severity in the multicenter study. In clinical trials, Targretin® gel was applied for up to 172 weeks.
Targretin® gel should be continued as long as the patient is deriving benefit.
Occlusive dressings should not be used with Targretin® gel.
Targretin® gel is a topical therapy and is not intended for systemic use.Targretin® gel has not been studied in combination with other CTCL therapies.
2.1 Dosing Schedule and AdministrationPremedicate with an antihistamine and acetaminophen prior to each Ontak infusion. Administer at 9 or 18 mcg/kg/day by intravenous infusion over 30-60 minutes for 5 consecutive days every 21 days for 8 cycles. Do not administer as a bolus injection. Withhold administration of Ontak if serum albumin levels are less than 3.0 g/dL. Discontinue for adverse infusion reactions.
2.2 Preparation and AdministrationThaw vials in the refrigerator at 2 to 8°C (36 to 46°F) for not more than 24 hours or at room temperature for 1 to 2 hours. Bring Ontak to room temperature, before preparing the dose. Mix the solution in the vial by gentle swirling; do not shake. Visually inspect for particulate matter and discoloration prior to administration, whenever solution and container permit. Use only if the solution is clear, colorless and without visible particulate matter. After thawing, a haze may be visible which should clear when the solution is at room temperature. Do not refreeze Ontak after thawing. Prepare and hold diluted Ontak in plastic syringes or soft plastic IV bags. Do not use glass containers. Maintain concentration of Ontak at 15 mcg/mL or higher. during all steps in the preparation of the solution for IV infusion. Withdraw the calculated dose from the vial(s) and inject it into an empty IV infusion bag. Do not add more than 9 mL of sterile saline without preservative to the IV bag for each 1 mL of Ontak. Do not mix Ontak with other drugs. Do not administer Ontak through an in-line filter. Administer prepared solutions of Ontak within 6 hours, using a syringe pump or IV infusion bag. Discard unused portions of Ontak immediately.
2.1 Dosing in Mild to Moderate Alzheimer’s Disease
The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ARICEPT in patients with mild to moderate Alzheimer’s disease is 10 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks.
2.2 Dosing in Moderate to Severe Alzheimer’s Disease
The recommended starting dosage of ARICEPT is 5 mg administered once per day in the evening, just prior to retiring. The maximum recommended dosage of ARICEPT in patients with moderate to severe Alzheimer’s disease is 23 mg per day. A dose of 10 mg should not be administered until patients have been on a daily dose of 5 mg for 4 to 6 weeks. A dose of 23 mg per day should not be administered until patients have been on a daily dose of 10 mg for at least 3 months.
2.3 Administration Information
ARICEPT should be taken in the evening, just prior to retiring. ARICEPT can be taken with or without food.
The ARICEPT 23 mg tablet should not be split, crushed, or chewed.
Allow ARICEPT ODT to dissolve on the tongue and follow with water.
2.1 Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily for four to eight weeks [see Indications and Usage (1.1)]. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered.
2.2 Maintenance of Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily. Controlled studies do not extend beyond 12 months [see Indications and Usage (1.2)].
2.3 Treatment of Symptomatic GERD in Adults
The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily for 4 weeks [see Indications and Usage (1.3)]. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
2.4 Healing of Duodenal Ulcers in Adults
The recommended adult oral dose is one ACIPHEX 20 mg Delayed-Release tablet to be taken once daily after the morning meal for a period up to four weeks [see Indications and Usage (1.5)]. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
2.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence in AdultsTABLE 1 THREE DRUG REGIMENa All three medications should be taken twice daily with the morning and evening meals.aIt is important that patients comply with the full 7-day regimen [see Clinical Studies (14.5)]. ACIPHEXDelayed-ReleaseTablet 20 mg Twice Daily for 7 Days Amoxicillin 1000 mg Twice Daily for 7 Days Clarithromycin 500 mg Twice Daily for 7 Days
2.6 Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
The dosage of ACIPHEX in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with ACIPHEX for up to one year.
2.7 Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
The recommended oral dose for adolescents 12 years of age and older is one 20 mg Delayed-Release Tablet once daily for up to 8 weeks [see Use in Specific Populations (8.4) and Clinical Studies (14.7)].
2.8 Treatment of GERD in Pediatric Patients 1 to 11 Years of Age
The recommended dosage of ACIPHEX Sprinkle for pediatric patients 1 to 11 years of age by body weight is:Less than 15 kg: 5 mg once daily for up to 12 weeks with the option to increase to 10 mg if inadequate response [see Clinical Studies (14.7)]. 15 kg or more: 10 mg once daily for up to 12 weeks [see Clinical Studies (14.7)].
2.9 Elderly, Renal, and Hepatic Impaired Patients
No dosage adjustment is necessary in elderly patients, in patients with renal disease, or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
2.10 Administration RecommendationsTABLE 2 ADMINSTRATION RECOMMENDATIONS Formulation Population Instructions Delayed-Release Tablet Adults and adolescents 12 years of age and older Swallow tablets whole. Do not chew, crush or split tablets.Tablets can be taken with or without food. Delayed-Release Capsule Pediatric patients 1 to 11 years of age The dose should be taken 30 minutes before a meal.The granules should not be chewed or crushed. Open capsule and sprinkle entire contents on a small amount of soft food (e.g. applesauce, fruit or vegetable based baby food, or yogurt) or empty contents into a small amount of liquid (e.g. infant formula, apple juice, or pediatric electrolyte solution). The whole dose should be taken within 15 minutes of preparation.Food or liquid should be at or below room temperature. Do not store mixture for future use.
FRAGMIN is administered by subcutaneous injection. It must not be administered by intramuscular injection.
FRAGMIN Injection should not be mixed with other injections or infusions unless specific compatibility data are available that support such mixing.
Routine coagulation tests such as Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) are relatively insensitive measures of FRAGMIN activity and, therefore, unsuitable for monitoring the anticoagulant effect of FRAGMIN. [see Warnings and Precautions (5)].
2.1 Adult Dosage
Prophylaxis of Ischemic Complications in Unstable Angina and Non-Q-Wave Myocardial Infarction: In patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose of FRAGMIN Injection is 120 IU/kg of body weight, but not more than 10,000 IU, subcutaneously every 12 hours with concurrent oral aspirin (75 to 165 mg once daily) therapy. Treatment should be continued until the patient is clinically stabilized. The usual duration of administration is 5 to 8 days. Concurrent aspirin therapy is recommended except when contraindicated.
Table 1 lists the volume of FRAGMIN, based on the 9.5 mL multiple-dose vial (10,000 IU/mL), to be administered for a range of patient weights.Table 1 Volume of FRAGMIN to be Administered by Patient Weight, Based on 9.5 mL Vial (10,000 IU/mL) Patientweight (lb) < 110 110 to 131 132 to 153 154 to 175 176 to 197 ≥ 198 Patientweight (kg) < 50 50 to 59 60 to 69 70 to 79 80 to 89 ≥ 90 Volume ofFRAGMIN (mL) 0.55 0.65 0.75 0.90 1.0 1.0
Prophylaxis of Venous Thromboembolism Following Hip Replacement Surgery: Table 2 presents the dosing options for patients undergoing hip replacement surgery. The usual duration of administration is 5 to 10 days after surgery; up to 14 days of treatment with FRAGMIN have been well tolerated in clinical trials.Table 2 Dosing Options for Patients Undergoing Hip Replacement Surgery Timing of First Dose of FRAGMIN Dose of FRAGMIN to be Given Subcutaneously 10 to 14 HoursBefore Surgery Within 2 HoursBefore Surgery 4 to 8 HoursAfter Surgery1 PostoperativePeriod2 Postoperative Start --- --- 2500 IU3 5000 IU once daily Preoperative Start - Day of Surgery --- 2500 IU 2500 IU3 5000 IU once daily Preoperative Start - Evening Before Surgery4 5000 IU --- 5000 IU 5000 IU once daily
1 Or later, if hemostasis has not been achieved.2 Up to 14 days of treatment was well tolerated in controlled clinical trials, where the usual duration of treatment was 5 to 10 days postoperatively.3 Allow a minimum of 6 hours between this dose and the dose to be given on Postoperative Day 1. Adjust the timing of the dose on Postoperative Day 1 accordingly.4 Allow approximately 24 hours between doses.
Abdominal Surgery: In patients undergoing abdominal surgery with a risk of thromboembolic complications, the recommended dose of FRAGMIN is 2500 IU administered by subcutaneous injection once daily, starting 1 to 2 hours prior to surgery and repeated once daily postoperatively. The usual duration of administration is 5 to 10 days.
In patients undergoing abdominal surgery associated with a high risk of thromboembolic complications, such as malignant disorder, the recommended dose of FRAGMIN is 5000 IU subcutaneously the evening before surgery, then once daily postoperatively. The usual duration of administration is 5 to 10 days. Alternatively, in patients with malignancy, 2500 IU of FRAGMIN can be administered subcutaneously 1 to 2 hours before surgery followed by 2500 IU subcutaneously 12 hours later, and then 5000 IU once daily postoperatively. The usual duration of administration is 5 to 10 days.
Medical Patients During Acute Illness: In medical patients with severely restricted mobility during acute illness, the recommended dose of FRAGMIN is 5000 IU administered by subcutaneous injection once daily. In clinical trials, the usual duration of administration was 12 to 14 days.
Extended Treatment of Symptomatic Venous Thromboembolism in Patients with Cancer: In patients with cancer and symptomatic venous thromboembolism, the recommended dosing of FRAGMIN is as follows: for the first 30 days of treatment administer FRAGMIN 200 IU/kg total body weight subcutaneously once daily. The total daily dose should not exceed 18,000 IU. Table 3 lists the dose of FRAGMIN to be administered once daily during the first month for a range of patient weights.
Month 1Table 3 Dose of FRAGMIN to be Administered Subcutaneously by Patient Weight during the First Month Body Weight (lbs) Body Weight (kg) FRAGMIN Dose (IU)(prefilled syringe)once daily ≤ 124 ≤ 56 10,000 125 to 150 57 to 68 12,500 151 to 181 69 to 82 15,000 182 to 216 83 to 98 18,000 ≥ 217 ≥ 99 18,000
Months 2 to 6
Administer FRAGMIN at a dose of approximately 150 IU/kg, subcutaneously once daily during Months 2 through 6. The total daily dose should not exceed 18,000 IU. Table 4 lists the dose of FRAGMIN to be administered once daily for a range of patient weights during months 2-6.Table 4 Dose of FRAGMIN to be Administered Subcutaneously by Patient Weight during Months 2-6 Body Weight (lbs) Body Weight (kg) FRAGMIN Dose (IU)(prefilled syringe)once daily ≤ 124 ≤ 56 7,500 125 to 150 57 to 68 10,000 151 to 181 69 to 82 12,500 182 to 216 83 to 98 15,000 ≥ 217 ≥ 99 18,000
Safety and efficacy beyond six months have not been evaluated in patients with cancer and acute symptomatic VTE [see Warnings and Precaution (5) and Adverse Reactions (6.1)].
2.2 Dose Reductions for Thrombocytopenia in Patients with Cancer and Acute Symptomatic VTE
In patients receiving FRAGMIN who experience platelet counts between 50,000 and 100,000/mm3, reduce the daily dose of FRAGMIN by 2,500 IU until the platelet count recovers to ≥ 100,000/mm3. In patients receiving FRAGMIN who experience platelet counts < 50,000/mm3, discontinue FRAGMIN until the platelet count recovers above 50,000/mm3.
2.3 Dose Reductions for Renal Insufficiency in Extended Treatment of Acute Symptomatic Venous Thromboembolism in Patients with Cancer
In patients with severely impaired renal function (CrCl < 30 mL/min), monitor anti-Xa levels to determine the appropriate FRAGMIN dose. Target anti-Xa range is 0.5-1.5 IU/mL. When monitoring anti-Xa in these patients, perform sampling 4-6 hrs after FRAGMIN dosing and only after the patient has received 3-4 doses.
Subcutaneous injection technique: Patients should be sitting or lying down and FRAGMIN administered by deep subcutaneous injection. FRAGMIN may be injected in a U-shape area around the navel, the upper outer side of the thigh or the upper outer quadrangle of the buttock. The injection site should be varied daily. When the area around the navel or the thigh is used, using the thumb and forefinger, you must lift up a fold of skin while giving the injection. The entire length of the needle should be inserted at a 45 to 90 degree angle.
Inspect FRAGMIN prefilled syringes and vials visually for particulate matter and discoloration prior to administration
After first penetration of the rubber stopper, store the multiple-dose vials at room temperature for up to 2 weeks. Discard any unused solution after 2 weeks.
Instructions for using the prefilled single-dose syringes preassembled with needle guard devices
Fixed dose syringes: To ensure delivery of the full dose, do not expel the air bubble from the prefilled syringe before injection. Hold the syringe assembly by the open sides of the device. Remove the needle shield. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose has been given. The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.
Graduated syringes: Hold the syringe assembly by the open sides of the device. Remove the needle shield. With the needle pointing up, prepare the syringe by expelling the air bubble and then continuing to push the plunger to the desired dose or volume, discarding the extra solution in an appropriate manner. Insert the needle into the injection area as instructed above. Depress the plunger of the syringe while holding the finger flange until the entire dose remaining in the syringe has been given. The needle guard will not be activated unless the entire dose has been given. Remove needle from the patient. Let go of the plunger and allow syringe to move up inside the device until the entire needle is guarded. Discard the syringe assembly in approved containers.
2.1 Dosage Information
Pediatric patients (1 year to less than 17 years)
The recommended starting daily dose of BANZEL in pediatric patients with Lennox-Gastaut Syndrome is approximately 10 mg/kg administered in two equally divided doses. The dose should be increased by approximately 10 mg/kg increments every other day until a maximum daily dose of 45 mg/kg, not to exceed 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than the target doses are effective.
Adults (17 years and older)
The recommended starting daily dose of BANZEL in adults with Lennox-Gastaut Syndrome is 400 to 800 mg per day administered in two equally divided doses. The dose should be increased by 400-800 mg every other day until a maximum daily dose of 3200 mg, administered in two equally divided doses, is reached. It is not known whether doses lower than 3200 mg are effective.
2.2 Administration Information
Administer BANZEL with food. BANZEL film-coated tablets can be administered whole, as half tablets or crushed.
BANZEL oral suspension should be shaken well before every administration. The provided adapter and calibrated oral dosing syringe should be used to administer the oral suspension. The adapter which is supplied in the product carton should be inserted firmly into the neck of the bottle before use and remain in place for the duration of the usage of the bottle. The dosing syringe should be inserted into the adapter and the dose withdrawn from the inverted bottle. The cap should be replaced after each use. The cap fits properly when the adapter is in place [see Patient Counseling Information (17)].
2.3 Dosing in Patients Undergoing Hemodialysis
Hemodialysis may reduce exposure to a limited (about 30%) extent. Accordingly, adjusting the BANZEL dose during the dialysis process should be considered [see Clinical Pharmacology (12.3)].
2.4 Dosing in Patients with Hepatic Disease
Use of BANZEL in patients with hepatic impairment has not been studied. Therefore, use in patients with severe hepatic impairment is not recommended. Caution should be exercised in treating patients with mild to moderate hepatic impairment [see Use in Specific Populations (8.7)].
2.5 Dosing in Patients Taking Valproate
Patients taking valproate should begin BANZEL at a dose lower than 10 mg/kg per day in pediatric patients or 400 mg per day in adults [see Drug Interactions (7.2)].
Vida Mia Hand Sanitizer Aloe Vera
The recommended dose of BELVIQ is 10 mg administered orally twice daily. Do not exceed recommended dose [see Warnings and Precautions (5.4) and Patient Counseling Information (17)].
BELVIQ can be taken with or without food.
Response to therapy should be evaluated by week 12. If a patient has not lost at least 5% of baseline body weight, discontinue BELVIQ, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment [see Clinical Studies (14)].
BMI is calculated by dividing weight (in kg) by height (in meters) squared.
A BMI chart for height in inches and weight in pounds is provided below:
Table 1. BMI Conversion Chart
Hydrocodone Bitartrate And Ibuprofen
2.1 Recommended Dose
The recommended dose of HALAVEN is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
The recommended dose of HALAVEN in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use in Specific Populations (8.6)].
The recommended dose of HALAVEN in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [see Use in Specific Populations (8.6)].
2.2 Dose Modification
Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.
Recommended dose delays
• The Day 8 dose may be delayed for a maximum of 1 week. ¯ If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose. ¯ If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate the next cycle no sooner than 2 weeks later.
Recommended dose reductionsIf a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Table 1. Do not re-escalate HALAVEN dose after it has been reduced. Table 1 Recommended Dose Reductions Event Description Recommended HALAVEN Dose Permanently reduce the 1.4 mg/m2 HALAVEN dose for any of the following: ANC <500/mm3 for >7 days ANC <1,000 /mm3 with fever or infection Platelets <25,000/mm3 1.1 mg/m2 Platelets <50,000/mm3 requiring transfusion Non-hematologic Grade 3 or 4 toxicities Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2 0.7 mg/m2 Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2 Discontinue HALAVEN ANC = absolute neutrophil count. Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
2.3 Instructions for Preparation and Administration
Aseptically withdraw the required amount of HALAVEN from the single-use vial and administer undiluted or diluted in 100 mL of 0.9% Sodium Chloride Injection, USP.
Do not dilute in or administer through an intravenous line containing solutions with dextrose. Do not administer in the same intravenous line concurrent with the other medicinal products.
Store undiluted HALAVEN in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration (40°F or/ 4°C). Store diluted solutions of HALAVEN for up to 4 hours at room temperature or up to 24 hours under refrigeration.
Discard unused portions of the vial.
2.1 Dosage for Partial-Onset Seizures
In patients not receiving concomitant enzyme-inducing antiepileptic drugs (AEDs), the recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by increments of 2 mg once daily no more frequently than at weekly intervals.
The recommended maintenance dose range is 8 mg to 12 mg once daily in the absence of enzyme-inducing AEDs, although some patients may respond to a dose of 4 mg daily. A dose of 12 mg once daily resulted in somewhat greater reductions in seizure rates than the dose of 8 mg once daily, but with a substantial increase in adverse reactions. Individual dosing should be adjusted based on clinical response and tolerability [see Clinical Studies (14)].
2.2 Dosage for Primary Generalized Tonic-Clonic Seizures
In patients not receiving concomitant enzyme-inducing AEDs, the recommended starting dosage of FYCOMPA is 2 mg once daily taken orally at bedtime. Increase dosage by increments of 2 mg once daily no more frequently than at weekly intervals.
In patients not taking enzyme-inducing AEDs, the recommended maintenance dose is 8 mg once daily taken at bedtime. Patients who are tolerating FYCOMPA well at 8 mg once daily and require further control of seizures may benefit from a dose increase up to 12 mg once daily if tolerated. Individual dosing should be adjusted based on clinical response and tolerability [see Clinical Studies (14)].
2.3 Dosing in the Presence of Concomitant Enzyme-Inducing Antiepileptic Drugs (AEDs)
Enzyme-inducing AEDs, including phenytoin, carbamazepine, and oxcarbazepine, cause a 50-67% reduction in FYCOMPA plasma levels [see Drug Interactions (7.2), Clinical Pharmacology (12.3)]. In patients receiving concomitant enzyme-inducing AEDs, the recommended starting dosage of FYCOMPA is 4 mg once daily taken orally at bedtime.
Increase dosage by increments of 2 mg once daily no more frequently than at weekly intervals. A maintenance dose has not been established in clinical trials. The highest dose studied in patients on concomitant enzyme-inducing AEDs was 12 mg once daily. Individual dosing should be adjusted based on clinical response and tolerability.
When enzyme-inducing AEDs are introduced or withdrawn from a patient’s treatment regimen, the patient should be closely monitored for clinical response and tolerability. Dose adjustment of FYCOMPA may be necessary.
2.4 Dosage Adjustment in Patients with Hepatic Impairment
In patients with mild and moderate hepatic impairment, the starting dose of FYCOMPA is 2 mg once daily. Increase dosage by increments of 2 mg once daily no more frequently than every 2 weeks. The maximum recommended daily dose is 6 mg for patients with mild hepatic impairment and 4 mg for patients with moderate hepatic impairment. FYCOMPA is not recommended for use in patients with severe hepatic impairment [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.5 Dosage Information for Patients with Renal Impairment
FYCOMPA can be used in patients with moderate renal impairment with close monitoring. A slower titration may be considered, based on clinical response and tolerability. FYCOMPA is not recommended in patients with severe renal impairment or patients undergoing hemodialysis [see Use in Specific Populations (8.7), Clinical Pharmacology (12.3)].
2.6 Dosage Information for Elderly Patients
In elderly patients, increase dosage no more frequently than every 2 weeks during titration [see Use in Specific Populations (8.5)].
There are two regimens for Dacogen administration. With either regimen it is recommended that patients be treated for a minimum of 4 cycles; however, a complete or partial response may take longer than 4 cycles.
Complete blood counts and platelet counts should be performed as needed to monitor response and toxicity, but at a minimum, prior to each cycle. Liver chemistries and serum creatinine should be obtained prior to initiation of treatment.
2.1 Treatment Regimen – Option 1
Dacogen is administered at a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days. This cycle should be repeated every 6 weeks. Patients may be premedicated with standard anti-emetic therapy.
If hematologic recovery (ANC ≥ 1,000/μL and platelets ≥ 50,000/μL) from a previous Dacogen treatment cycle requires more than 6 weeks, then the next cycle of Dacogen therapy should be delayed and dosing temporarily reduced by following this algorithm:Recovery requiring more than 6, but less than 8 weeks − Dacogen dosing to be delayed for up to 2 weeks and the dose temporarily reduced to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy. Recovery requiring more than 8, but less than 10 weeks − Patient should be assessed for disease progression (by bone marrow aspirates); in the absence of progression, the Dacogen dose should be delayed up to 2 more weeks and the dose reduced to 11 mg/m2 every 8 hours (33 mg/m2/day, 99 mg/m2/cycle) upon restarting therapy, then maintained or increased in subsequent cycles as clinically indicated.
2.2 Treatment Regimen – Option 2
Dacogen is administered at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily for 5 days. This cycle should be repeated every 4 weeks. Patients may be premedicated with standard anti-emetic therapy.
If myelosuppression is present, subsequent treatment cycles of Dacogen should be delayed until there is hematologic recovery (ANC ≥ 1,000/μL platelets ≥ 50,000/μL ).
2.3 Patients with Non-hematologic Toxicity
Following the first cycle of Dacogen treatment, if any of the following non-hematologic toxicities are present, Dacogen treatment should not be restarted until the toxicity is resolved: 1) serum creatinine ≥ 2 mg/dL; 2) SGPT, total bilirubin ≥ 2 times ULN; 3) and active or uncontrolled infection.
2.4 Instructions for Intravenous Administration
Dacogen is a cytotoxic drug and caution should be exercised when handling and preparing Dacogen. Procedures for proper handling and disposal of antineoplastic drugs should be applied. Several guidances on this subject have been published.1-4.
Dacogen should be aseptically reconstituted with 10 mL of Sterile Water for Injection (USP); upon reconstitution, each mL contains approximately 5.0 mg of decitabine at pH 6.7-7.3. Immediately after reconstitution, the solution should be further diluted with 0.9% Sodium Chloride Injection or 5% Dextrose Injection to a final drug concentration of 0.1 - 1.0 mg/mL. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold (2˚C - 8˚C) infusion fluids and stored at 2˚C - 8˚C (36˚F - 46˚F) for up to a maximum of 4 hours until administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if there is evidence of particulate matter or discoloration.
2.1 Recommended Dosing
Chemotherapy-Induced Nausea and VomitingAge Dose* Infusion Time Adults 0.25 mg x 1
Infuse over 30 seconds beginning approx. 30 min before the start of chemo
Pediatrics(1 month to less than 17 years)
20 micrograms per kilogram (max 1.5 mg) x 1
Infuse over 15 minutes beginning approx. 30 min before the start of chemo*Note different dosing units in pediatrics
Postoperative Nausea and VomitingDosage for Adults - a single 0.075 mg intravenous dose administered over 10 seconds immediately before the induction of anesthesia.
2.2 Instructions for Intravenous Administration
ALOXI is supplied ready for intravenous administration at a concentration of 0.05 mg/mL (50 mcg/ mL). ALOXI should not be mixed with other drugs. The infusion line should be flushed with normal saline before and after administration of ALOXI. Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.
Highly Emetogenic Chemotherapy, including Cisplatin Based Chemotherapy
The recommended dosage in adults is one capsule of AKYNZEO administered approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1 and 8 mg orally once daily on days 2 to 4 [see Clinical Studies (14),Table 5].
Anthracyclines and Cyclophosphamide Based Chemotherapy and Chemotherapy Not Considered Highly Emetogenic
The recommended dosage in adults is one capsule of AKYNZEO approximately 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy on day 1. Administration of dexamethasone on days 2 to 4 is not necessary [see Clinical Studies (14), Table 7].
AKYNZEO can be taken with or without food.
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