Data from FDA - Curated by Toby Galbraith - Last updated 02 September 2017

Indication(s)

INDICATIONS AND USAGE Megestrol acetate oral suspension is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).

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Advisory information

contraindications
CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
Special warnings and precautions
PRECAUTIONS General Therapy with megestrol acetate oral suspension for weight loss should only be instituted after treatable causes of weight loss are sought and addressed. These treatable causes include possible malignancies, systemic infections, gastrointestinal disorders affecting absorption, endocrine disease, and renal or psychiatric diseases. Effects on HIV viral replication have not been determined. Use with caution in patients with a history of thromboembolic disease. Use in Diabetics Exacerbation of preexisting diabetes with increased insulin requirements has been reported in association with the use of megestrol acetate. Information for Patients Patients using megestrol acetate should receive the following instructions: 1) This medication is to be used as directed by the physician. 2) Report any adverse reaction experiences while taking this medication. 3) Use contraception while taking this medication if you are a woman capable of becoming pregnant. 4) Notify your physician if you become pregnant while taking this medication. Drug Interactions Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied. Animal Toxicology Long-term treatment with megestrol acetate may increase the risk of respiratory infections. A trend toward increased frequency of respiratory infections, decreased lymphocyte counts, and increased neutrophil counts was observed in a 2-year chronic toxicity/carcinogenicity study of megestrol acetate conducted in rats. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis Data on carcinogenesis were obtained from studies conducted in dogs, monkeys, and rats treated with megestrol acetate at doses 53.2, 26.6, and 1.3 times lower than the proposed dose (13.3 mg/kg/day) for humans. No males were used in the dog and monkey studies. In female beagles, megestrol acetate (0.01, 0.1, or 0.25 mg/kg/day) administered for up to 7 years induced both benign and malignant tumors of the breast. In female monkeys, no tumors were found following 10 years of treatment with 0.01, 0.1, or 0.5 mg/kg/day megestrol acetate. Pituitary tumors were observed in female rats treated with 3.9 or 10 mg/kg/day of megestrol acetate for 2 years. The relationship of these tumors in rats and dogs to humans is unknown but should be considered in assessing the risk-to-benefit ratio when prescribing megestrol acetate oral suspension and in surveillance of patients on therapy. (See WARNINGS .) Mutagenesis No mutagenesis data are currently available. Impairment of Fertility Perinatal/postnatal (segment III) toxicity studies were performed in rats at doses (0.05–12.5 mg/kg) less than that indicated for humans (13.3 mg/kg); in these low dose studies, the reproductive capability of male offspring of megestrol acetate-treated females was impaired. Similar results were obtained in dogs. Pregnant rats treated with megestrol acetate showed a reduction in fetal weight and number of live births, and feminization of male fetuses. No toxicity data are currently available on male reproduction (spermatogenesis). Pregnancy Pregnancy Category X. (See WARNINGS and PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility : Impairment of Fertility.) No adequate animal teratology information is available at clinically relevant doses. Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate oral suspension is required. Use in Women Breakthrough bleeding was observed in all 10 female patients participating in the clinical trials. Megestrol acetate is a progesterone derivative, which may induce vaginal bleeding in women. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of megestrol acetate oral suspension in the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with AIDS did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Megestrol acetate is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Adverse reactions
ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Clinical Adverse Events Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. These adverse events should be considered by the physician when prescribing megestrol acetate oral suspension. ADVERSE EVENTS % of Patients Reporting Megestrol Acetate, mg/day No. of Patients Trial 1 (N=236) Placebo 0 100 400 800 N=34 N=68 N=69 N=65 Trial 2 (N=87) Placebo 0 800 N=38 N=49 Open Label Trial 1200 N=176 Diarrhea Impotence Rash Flatulence Hypertension Asthenia Insomnia Nausea Anemia Fever Libido Decreased Dyspepsia Hyperglycemia Headache Pain Vomiting Pneumonia Urinary Frequency 15 13 8 15 3 4 6 14 9 9 4 12 9 0 1 9 0 0 0 8 3 2 3 6 0 3 4 6 9 4 0 5 6 3 3 5 3 6 4 5 3 4 0 5 0 0 3 3 3 0 6 3 6 10 1 3 6 0 0 2 9 3 0 2 6 2 0 2 0 0 1 2 8 6 NaN4 3 2 3 10 NaN0 8 4 NaN0 3 4 NaN0 3 2 NaN2 5 4 NaN0 3 0 5 6 3 6 3 0 5 2 10 7 6 6 4 5 1 5 0 1 1 2 3 3 4 4 1 1 Adverse events which occurred in 1% to 3% of all patients enrolled in the two clinical efficacy trials with at least one follow-up visit during the first 12 weeks of the study are listed below by body system. Adverse events occurring less than 1% are not included. There were no significant differences between incidence of these events in patients treated with megestrol acetate and patients treated with placebo. Body as a Whole: abdominal pain, chest pain, infection, moniliasis and sarcoma Cardiovascular System: cardiomyopathy and palpitation Digestive System: constipation, dry mouth, hepatomegaly, increased salivation and oral moniliasis Hemic and Lymphatic System: leukopenia Metabolic and Nutritional: LDH increased, edema and peripheral edema Nervous System: paresthesia, confusion, convulsion, depression, neuropathy, hypesthesia and abnormal thinking Respiratory System: dyspnea, cough, pharyngitis and lung disorder Skin and Appendages: alopecia, herpes, pruritus, vesiculobullous rash, sweating and skin disorder Special Senses: amblyopia Urogenital System: albuminuria, urinary incontinence, urinary tract infection and gynecomastia Postmarketing Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis and pulmonary embolism, and glucose intolerance (see WARNINGS and PRECAUTIONS ).

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION The recommended adult initial dosage of megestrol acetate oral suspension is 800 mg/day (20 mL/day). Shake container well before using. In clinical trials evaluating different dose schedules, daily doses of 400 and 800 mg/day were found to be clinically effective. A plastic dosage cup with 10 mL and 20 mL markings is provided for convenience in the 240 mL carton.
Pregnancy and lactation
Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate oral suspension is required. Use in Women Breakthrough bleeding was observed in all 10 female patients participating in the clinical trials. Megestrol acetate is a progesterone derivative, which may induce vaginal bleeding in women.

Interactions

Drug Interactions Pharmacokinetic studies show that there are no significant alterations in pharmacokinetic parameters of zidovudine or rifabutin to warrant dosage adjustment when megestrol acetate is administered with these drugs. The effects of zidovudine or rifabutin on the pharmacokinetics of megestrol acetate were not studied.

More information

Category Value
Authorisation number ANDA203960
Agency product number TJ2M0FR8ES
Orphan designation No
Product NDC 50383-859
Date Last Revised 09-06-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 860225
Marketing authorisation holder Hi-Tech Pharmacal Co., Inc.