Megestrol Drug Information
Generic name: MEGESTROL ACETATE
Uses of Megestrol
Megestrol acetate oral suspension, USP is indicated for the treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS).
Dosage & Administration of Megestrol
The recommended adult initial dosage of megestrol acetate oral suspension, USP 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.
Side Effects of Megestrol
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 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 ). To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or go to www.strides.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
| ADVERSE EVENTS% of Patients Reporting | |||||||
| Trial 1 (N = 236) | Trail 2 (N=87) | Open Label Trial | |||||
| Megestrol Acetate mg/day No. of Patients | Placebo 0 N=34 | 100 N=68 | 400 N=69 | 800 N=65 | Placebo 0 N=38 | 800 N=49 | 1200 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 | 0 | 2 | 2 | 3 | 0 | 1 |
| Urinary Frequency | 0 | 0 | 1 | 2 | 5 | 2 | 1 |
Warnings & Cautions for Megestrol
Megestrol acetate may cause fetal harm when administered to a pregnant woman. For animal data on fetal effects, (see PRECAUTIONS: Carcinogenesis, Mutagenesis, Impairment of Fertility: Impairment of Fertility ). There are no adequate and well-controlled studies in pregnant women.
If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant. Megestrol acetate is not intended for prophylactic use to avoid weight loss. (See also PRECAUTIONS: Carcinogenesis, Mutagenesis, and Impairment of Fertility section.) The glucocorticoid activity of megestrol acetate oral suspension has not been fully evaluated.
Clinical cases of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and overt Cushing's Syndrome have been reported in association with the chronic use of megestrol acetate. In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate therapy in the stressed and non-stressed state. Furthermore, adrenocorticotropin (ACTH) stimulation testing has revealedthe frequent occurrence of asymptomatic pituitary-adrenal suppression in patients treated with chronic megestrol acetate therapy.
Therefore, the possibility of adrenal insufficiency should be considered in any patient receiving or being withdrawn from chronic megestrol acetate therapy who presents with symptoms and/or signs suggestive of hypoadrenalism (e.g., hypotension, nausea, vomiting, dizziness, or weakness) in either the stressed or non-stressed state. Laboratory evaluation for adrenal insufficiency and consideration of replacement or stress doses of a rapidly acting glucocorticoid are strongly recommended in such patients. Failure to recognize inhibition of the hypothalamic-pituitary-adrenal axis may result in death.
Finally, in patients who are receiving or being withdrawn from chronic megestrol acetate therapy, consideration should be given to the use of empiric therapy with stress doses of a rapidly acting glucocorticoid in conditions of stress or serious intercurrent illness (e.g., surgery, infection).
Contraindications for Megestrol
History of hypersensitivity to megestrol acetate or any component of the formulation. Known or suspected pregnancy.
Overdosage Information for Megestrol
No serious unexpected side effects have resulted from studies involving megestrol acetate oral suspension administered in dosages as high as 1200 mg/day. In post-marketing experience, limited reports of overdose have been received. Signs and symptoms reported in the context of overdose included diarrhea, nausea, abdominal pain, shortness of breath, cough, unsteady gait, listlessness, and chest pain.
There is no specific antidote for overdose with megestrol acetate oral suspension. In case of overdose, appropriate supportive measures should be taken. Megestrol acetate has not been tested for dialyzability, however, due to its low solubility it is postulated that dialysis would not be an effective means of treating overdose
Clinical Studies of Megestrol
The clinical efficacy of megestrol acetate oral suspension was assessed in two clinical trials. One was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate (MA) at doses of 100 mg, 400 mg, and 800 mg per day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Of the 270 patients entered on study, 195 met all inclusion/exclusion criteria, had at least two additional post baseline weight measurements over a 12 week period or had one post baseline weight measurement but dropped out for therapeutic failure.
The percent of patients gaining five or more pounds at maximum weight gain in 12 study weeks was statistically significantly greater for the MA-treated groups than for the placebo group (24%). Mean weight changes at 4, 8 and 12 weeks for patients evaluable for efficacy in the two clinical trials are shown graphically. Changes in body composition during the 12 study weeks as measured by bioelectrical impedance analysis showed increases innon-water body weight in the MA-treated groups (see CLINICAL STUDIES table).
In addition, edema developed or worsened in only 3 patients. Greater percentages of MA-treated patients in the %, showed an improvement in appetite at last evaluation during the 12 study weeks. A statistically significant difference was observed between the 800 mg MA-treated group and the placebo group in the change in caloric intake from baseline to time of maximum weight change.
Patients were asked to assess weight change, appetite, appearance, and overall perception of well-being in a 9 question survey. At maximum weight change only the 800 mg MA-treated group gave responses that were statistically significantly more favorable to all questions when compared to the placebo-treated group. A dose response was noted in the survey with positive responses correlating with higher dose for all questions.
The second trial was a multicenter, randomized, double-blind, placebo-controlled study comparing megestrol acetate 800 mg/day versus placebo in AIDS patients with anorexia/cachexia and significant weight loss. Patients in the 800 mg MA-treated group had a statistically significantly larger increase in mean maximum weight change than patients in the placebo group. From baseline to study week 12, mean weight increased by 11.2 pounds in the MA-treated group and decreased 2.1 pounds in the placebo group.
No edema was reported in the MA-treated group. There were no statistically significant differences between treatment groups in mean caloric change or in daily caloric intake at time to maximum weight change. In the same 9 question survey referenced in the first trial, patients' assessments of weight change, appetite, appearance, and overall perception of well-being showed increases in mean scores in MA-treated patients as compared to the placebo group.
In both trials, no statistically significant differences were seen between the treatment groups with regard to laboratory abnormalities,, new opportunistic infections, lymphocyte counts, T 4 counts, T 8 counts, or skin reactivity tests ( see ADVERSE REACTIONS ).
| Megestrol Acetate Oral Suspension Clinical Efficacy Trials | ||||||
| Trial 1 Study Accrual Dates 11/88 to 12/90 | Trial 2 Study Accrual Dates 5/89 to 4/91 | |||||
| Megestrol Acetate, mg/day | 0 | 100 | 400 | 800 | 0 | 800 |
| Entered Patients | 38 | 82 | 75 | 75 | 48 | 52 |
| Evaluable Patients | 28 | 61 | 53 | 53 | 29 | 36 |
| Mean Change in Weight (lb) | ||||||
| Baseline to 12 Weeks | 0.0 | 2.9 | 9.3 | 10.7 | -2.1 | 11.2 |
| % Patients ≥ 5 Pound Gain at Last Evaluation in 12 Weeks | 21 | 44 | 57 | 64 | 28 | 47 |
| Mean Changes in Body Composition* | ||||||
| Fat Body Mass (lb.) | 0.0 | 2.2 | 2.9 | 5.5 | 1.5 | 5.7 |
| Lean Body Mass (lb.) | -1.7 | -0.3 | 1.5 | 2.5 | -1.6 | -0.6 |
| Water (liters) | -1.3 | -0.3 | 0.0 | 0.0 | -0.1 | -0.1 |
| % Patients With Improved Appetite: | ||||||
| At Time of Maximum Weight Change | 50 | 72 | 72 | 93 | 48 | 69 |
| At Last Evaluation in 12 Weeks | 50 | 72 | 68 | 89 | 38 | 67 |
| Mean Change in Daily Caloric Intake: | ||||||
| Baseline to Time of Maximum Weight Change | -107 | 326 | 308 | 646 | 30 | 464 |
| *Based on bioelectrical impedance analysis determinations at last evaluation in 12 weeks. | ||||||
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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