Data from FDA - Curated by Marshall Pearce - Last updated 31 December 2017

Indication(s)

1. 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). Megestrol acetate oral suspension is a progestin indicated for the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS) (1). 1.1 Limitations of Use Other Treatable Causes Therapy with megestrol acetate 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, renal disease or psychiatric diseases. Prophylactic Use Megestrol acetate is not intended for prophylactic use to avoid weight loss.

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Advisory information

contraindications
4. CONTRAINDICATIONS History of hypersensitivity to megestrol acetate or any component of the formulation (4.1). Known or suspected pregnancy (4.2)(8.1). 4.1 Hypersensitivity Reaction History of hypersensitivity to megestrol acetate or any component of the formulation. 4.2 Pregnancy Known or suspected pregnancy.
Adverse reactions
6. ADVERSE REACTIONS The most common adverse events occurring in > 5% of all patients receiving 800mg/20mL of megestrol acetate oral suspension in the two clinical efficacy trials were nausea, diarrhea, impotence, rash, flatulence, hypertension, and asthenia (6.2). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical Inc. at 1-800-367-3395 or go to www.bpirx.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Serious and Otherwise Important Adverse Reactions The following serious reactions and otherwise important adverse drug reactions are discussed in greater detail in other sections of the labeling: Hypersensitivity [see Contraindications (4.1)] Pregnancy [see Contraindications (4.2)] Fetal Effects [see Warnings and Precautions (5.2)] Thromboembolic Disease [see Warnings and Precautions (5.1)] Adrenal Insufficiency [see Warnings and Precautions (5.3)] 6.2 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reactions observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of megestrol acetate oral suspension was based on three studies of megestrol acetate oral suspension (40 mg/mL). The adverse reaction profile of these 3 studies are presented below. Adverse events which occurred in at least 5% of patients in any arm of the two clinical efficacy trials and the open trial for megestrol acetate oral suspension are listed below by treatment group. All patients listed had at least one post baseline visit during the 12 study weeks. Table 1: Adverse Events Percentage of Patients Reporting Adverse Events Trial 1 (N= 236) Trial 2 (N=87) Open Label Trial Placebo Placebo Megestrol Acetate mg/day 0 100 400 800 0 800 1200 No. of Patients N=34 N=68 N=69 N=65 N=38 N=49 N=176 Diarrhea 15 13 8 15 8 6 10 Impotence 3 4 6 14 0 4 7 Rash 9 9 4 12 3 2 6 Flatulence 9 0 1 9 3 10 6 Hypertension 0 0 0 8 0 0 4 Asthenia 3 2 3 6 8 4 5 Insomnia 0 3 4 6 0 0 1 Nausea 9 4 0 5 3 4 5 Anemia 6 3 3 5 0 0 0 Fever 3 6 4 5 3 2 1 Libido Decreased 3 4 0 5 0 2 1 Dyspepsia 0 0 3 3 5 4 2 Hyperglycemia 3 0 6 3 0 0 3 Headache 6 10 1 3 3 0 3 Pain 6 0 0 2 5 6 4 Vomiting 9 3 0 2 3 6 4 Pneumonia 6 2 0 2 3 0 1 Urinary Frequency 0 0 1 2 5 2 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. 6.3 Postmarketing Experience Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance [see Warnings and Precautions (5.1, 5.4)].

Usage information

Dosing and administration
2. DOSAGE AND ADMINISTRATION The recommended adult initial dosage of megestrol acetate oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Shake the container well before using. This strength (125 mg/mL) is not substitutable with other strengths (e.g., 40 mg/mL). Refer to the prescribing information of the 40 mg/mL product for dosage recommendations for the 40 mg/mL strength. The recommended adult initial dosage of megestrol acetate oral suspension is 625 mg/day (5 mL/day or one teaspoon daily). Shake container well before using (2).
Use in special populations
8. USE IN SPECIFIC POPULATIONS Geriatrics: 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 therapy (8.5). Nursing Mothers: Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate oral suspension is required (8.3). 8.1 Pregnancy Pregnancy Category X [see Warnings and Precautions (5.2)]. No adequate animal teratology information is available at clinically relevant doses. Pregnant rats treated with low doses of megestrol acetate (0.02-fold the recommended clinical dose) resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses. 8.3 Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate oral suspension is required. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 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. 8.6 Use in Women Megestrol acetate has had limited use in HIV infected women. All 10 women in the clinical trials reported breakthrough bleeding. Megestrol acetate oral suspension is a progesterone derivative, which may induce vaginal bleeding in women.
Pregnancy and lactation
8.3 Nursing Mothers Because of the potential for adverse effects on the newborn, nursing should be discontinued if megestrol acetate oral suspension is required.

Interactions

7. DRUG INTERACTIONS Due to a significant decrease in indinavir exposure, administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate (7.1, 12.3). 7.1 Indinavir Due to the significant decrease in the exposure of indinavir by megestrol acetate, administration of a higher dose of indinavir should be considered when coadministering with megestrol acetate [See Clinical Pharmacology (12.3)]. 7.2 Zidovudine and Rifabutin No dosage adjustment for zidovudine and rifabutin is needed when megestrol acetate is coadministered with these drugs [See Clinical Pharmacology (12.3)].

More information

Category Value
Authorisation number ANDA204688
Agency product number TJ2M0FR8ES
Orphan designation No
Product NDC 51991-313
Date Last Revised 04-12-2017
Type HUMAN PRESCRIPTION DRUG
RXCUI 577154
Storage and handling 16.2 Storage Store Megestrol acetate oral suspension, USP between 20° to 25°C (68° to 77° F) [see USP Controlled Room Temperature]. Dispense in a tight container. Protect from heat.
Marketing authorisation holder Breckenridge Pharmaceutical, Inc.