Data from FDA - Curated by Marshall Pearce - Last updated 06 November 2017

Indication(s)

INDICATIONS AND USAGE Megestrol Acetate Tablets are indicated for the palliative treatment of advanced carcinoma of the breast or endometrium (i.e., recurrent, inoperable, or metastatic disease). It should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy.

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Advisory information

contraindications
CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation.
Special warnings and precautions
PRECAUTIONS General Close surveillance is indicated for any patient treated for recurrent or metastatic cancer. 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 the 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. Laboratory Tests Breast malignancies in which estrogen and/or progesterone receptors are positive are more likely to respond to megestrol acetate. Carcinogenesis, Mutagenesis, and Impairment of Fertility Administration of megestrol acetate to female dogs for up to 7 years is associated with an increased incidence of both benign and malignant tumors of the breast. Comparable studies in rats and studies in monkeys are not associated with an increased incidence of tumors. The relationship of the dog tumors to humans is unknown but should be considered in assessing the benefit-to-risk ratio when prescribing megestrol acetate and in surveillance of patients on therapy (see WARNINGS section). Pregnancy Pregnancy Category D. (See WARNINGS section.) Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate is required for treatment of cancer. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Insufficient data from clinical studies of megestrol acetate tablets are available for patients 65 years of age 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 Weight Gain Weight gain is a frequent side effect of megestrol acetate. This gain has been associated with increased appetite and is not necessarily associated with fluid retention. Thromboembolic Phenomena Thromboembolic phenomena including thrombophlebitis and pulmonary embolism (in some cases fatal) have been reported. Glucocorticoid Effects (See WARNINGS section.) Other Adverse Reactions Heart failure, nausea and vomiting, edema, breakthrough menstrual bleeding, dyspnea, tumor flare (with or without hypercalcemia), hyperglycemia, glucose intolerance, alopecia, hypertension, carpal tunnel syndrome, mood changes, hot flashes, malaise, asthenia, lethargy, sweating and rash.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION Breast Cancer: 160 mg/day (40 mg qid). Endometrial Carcinoma: 40 to 320 mg/day in divided doses. At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of megestrol acetate tablets.
Pregnancy and lactation
Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate is required for treatment of cancer.

More information

Category Value
Authorisation number ANDA074621
Agency product number TJ2M0FR8ES
Orphan designation No
Product NDC 0555-0607,0555-0606
Date Last Revised 19-10-2017
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Teva Pharmaceuticals USA, Inc.