Frequently Asked Questions (FAQs) About Megace ES

What is Megace ES?

Megace ES (megestrol acetate) is a concentrated suspension indicated for the treatment of anorexia (loss of appetite), cachexia (severe malnutrition), and/or an unexplained, significant weight loss in patients with acquired immunodeficiency syndrome (AIDS).¹

What can AIDS patients expect from Megace ES?

Patients can expect Megace ES to increase their appetite, caloric intake, and weight gain, and help them improve their overall sense of well-being.¹ In clinical trials, most patients experienced results within 12 weeks.¹

How is Megace ES prescribed?

The recommended adult dosage of Megace ES is 625 mg/day (5 mL/day or one teaspoon once daily).¹ Megace ES can be taken without regard to meals.

What flavor is Megace ES?

Megace ES is available as a milky-white, lemon-lime flavored concentrated oral suspension.¹

How does Megace ES differ from original formula Megace^®?*

Although Megace ES 625 mg/5 mL is bioequivalent to Megace 800 mg/20 mL in the fed condition, Megace ES differs from the original formulation of megestrol acetate oral suspension in that

• Megace ES offers improved bioavailability in the unfed condition vs. original formula Megace^†1

• Megace ES has a smaller recommended volume per dose of 1 teaspoon once daily vs. 4 teaspoons once daily of Megace¹

• Megace ES is less viscous than the original formulation⁶

Why does Megace ES have increased bioavailability in the unfed state vs. Megace?

The NanoCrystal^® Technology delivery system¹² improves the solubility and bioavailability of megestrol acetate so that the bioavailability of Megace ES is only minimally affected when taken without food.¹

What are the most common adverse events associated with Megace ES?

The most common adverse events associated with Megace ES 625 mg/5 mL and megestrol acetate oral suspension 800 mg/20 mL are impotence, flatulence, rash, hypertension, fever, decreased libido, insomnia, dyspepsia, and hyperglycemia.^‡ Women who participated in studies reported breakthrough bleeding.

Megace ES and megestrol acetate oral suspension are contraindicated in patients with a history of hypersensitivity to megestrol acetate or any component of the formulation, or in patients with known or suspected pregnancy. Nursing should be discontinued while taking Megace ES.

Reports of new onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, overt Cushing’s Syndrome, and adrenal insufficiency have been associated with chronic megestrol acetate use.

Use with caution in patients with a history of thromboembolic disease. Dose modification may be necessary for the elderly, and could be considered in patients with compromised renal function.

Megace ES is available by Prescription Only. For complete Prescribing Information, click here.

What is considered unintended weight loss?

Unintended weight loss is an involuntary decrease in body weight²² and is associated with morbidity and reduced quality of life in AIDS patients.²⁶ In AIDS patients, weight loss is serious enough to treat if the patient, without trying, has lost

• 7.5% or more of his or her body weight over 6 months⁵

• 10% or more of his or her body weight over 12 months⁵

*Megestrol acetate oral suspension.

^†Clinical significance unknown. Megace ES has improved absorption over original formula Megace in people who have not eaten (the unfed state). For people who have eaten (fed condition), Megace ES and original formula Megace have similar absorption into the body. The fed condition is achieved by subjects eating a high-calorie (800-1000 calories) and high-fat (approximately 50% of total calories) meal.¹⁶

^‡Adverse events greater than placebo derived from the comprehensive adverse events table (≥5%) in Megace ES and megestrol acetate oral suspension prescribing information.