Classes
DEA Class; Rx
Common Brand Names; Megace, Megace ES
- Antineoplastics, Hormones;
- Progestins;
- Appetite Stimulants
Description
Synthetic oral progestin with slight glucocorticoid and mineralocorticoid activity; lacks estrogenic, androgenic, or anabolic effects
Used for appetite stimulation and the palliative treatment of advanced breast or endometrial cancer
Used off-label for endometriosis, hormone-refractory prostate cancer, metastatic renal cell cancer, hot flashes
Indications
Indicated for the treatment of anorexia, cachexia, or unexplained weight loss. In adult patients with acquired immunodeficiency syndrome (AIDS).
In pediatric patients with chronic conditions (e.g., cancer, cystic fibrosis, chronic kidney disease, human immunodeficiency virus [HIV]).
For the palliative treatment of advanced, inoperable, recurrent metastatic breast cancer.
For the palliative treatment of advanced, inoperable, recurrent metastatic endometrial cancer.
For the treatment of advanced hormone-refractory prostate cancer.
For the treatment of endometriosis-associated pain.
For the treatment of hot flashes in women with a history of breast cancer or in men with prostate cancer who have undergone androgen-deprivation therapy.
Contraindications
Known or suspected pregnancy
Acute thrombophlebitis, thromboembolic disorder, breast cancer
Undiagnosed abnormal genital bleeding
Prophylaxis of weight loss
Documented hypersensitivity
May induce vaginal bleeding in women
Adverse Effects
Common
- Hypertension
- Insomnia, mood swings
- Rash, sweating
- Amenorrhea, breakthrough bleeding, change in menstrual flow, hot sweats, impotence, spotting
- Diarrhea, flatulence, indigestion, nausea, vomiting, weight gain
Serious
- Deep vein thrombosis (DVT)
- Pulmonary embolism
- Thrombophlebitis
- Anemia
- Adrenal insufficiency
Warnings
Diabetes mellitus
History of thromboembolic disease
Not to be used as prophylaxis against weight loss or as diagnostic test for pregnancy
Adrenal insufficiency may occur in patients receiving or being withdrawn from long-term megestrol treatment
Megestrol is a progesterone derivative which may induce vaginal bleeding in women
Cushing syndrome reported with thearpy
Pregnancy and Lactation
Pregnancy
Obtain a pregnancy test in females of reproductive potential prior to initiating treatment; advise females of reproductive potential to use effective contraception while taking drug
There are no available human data to assess for any drug-associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes; advise a pregnant women of potential risk to fetus
Lactation
The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1; the drug is present in human milk; there are no data on effects of drug on breastfed infant or on milk production; because of potential for HIV transmission and adverse effects on a breastfed infant, instruct mothers not to breastfeed if they are receiving therapy
Maximum Dosage
Adults
Specific maximum dose information is not available for oncologic treatments; see indications. 800 mg/day PO (40 mg/mL suspension) or 625 mg/day PO (125 mg/mL suspension) for anorexia/cachexia.
Geriatric
Specific maximum dose information is not available for oncologic treatments; see indications. 800 mg/day PO (40 mg/mL suspension) or 625 mg/day PO (125 mg/mL suspension) for anorexia/cachexia.
Adolescents
Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO or 800 mg/day PO have been used off-label for anorexia/cachexia.
Children
Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO or 800 mg/day PO have been used off-label for anorexia/cachexia.
Infants
6 to 11 months: Safety and efficacy have not been established; however, doses up to 15 mg/kg/day PO or 800 mg/day PO have been used off-label for anorexia/cachexia.
1 to 5 months: Safety and efficacy have not been established.
How supplied
Megestrol (Acetate)