FDA

Megestrol Acetate

Approved 27 Aug 2014OralSuspension

The FDA lists this product in 17 strengths and forms.

Indications

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). Limitations of Use Therapy with megestrol acetate oral suspension for weight loss should only be insti‑tuted 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.

Megestrol acetate oral suspension is not intended for prophylactic use to avoid weight loss. 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) .

Contraindications

History of hypersensitivity to megestrol acetate or any component of the formulation.
Pregnancy [see Warnings and Precautions ( 5.2 ), Use in Specific Populations ( 8.1 , 8.3 )].
History of hypersensitivity to megestrol acetate or any component of the formulation ( 4 ).
Pregnancy ( 4 )( 8.1 ).

Warnings and precautions

Use with caution in patients with a history of thromboembolic disease (5.1) .
Fetal Effects: May cause fetal harm. Females of reproductive potential should be advised to avoid becoming pregnant ( 5.2 ).
Clinical cases of 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 In addition, clinical cases of adrenal insufficiency have been observed in patients receiving or being withdrawn from chronic megestrol acetate in the stressed and non-stressed state (5.3) .
New onset and exacerbation of pre-existing diabetes have been reported (5.4) .

5.1 General

Effects on HIV viral replication have not been determined.
Use with caution in patients with a history of thromboembolic disease.

5.2Fetal Toxicity Based

on animal studies, megestrol acetate may cause fetal harm when administered to a pregnant woman. Pregnant rats treated with low doses of megestrol acetate resulted in a reduction in fetal weight and number of live births, and feminization of male fetuses. There are no available human data to assess for any drug associated risks of miscarriage, birth defects, or adverse maternal or fetal outcomes. If this drug is used during pregnancy, or if the patient becomes pregnant while taking (receiving) this drug, advise the patient of the poten ‑ tial hazard to the fetus [see Use in Specific Populations ( 8.1 ), Nonclinical Toxicology ( 13.1 )].

At a glance

Brand name: Megestrol Acetate
Route: Oral
Dosage form: Suspension
Applicant: Twi Pharms
Status: Prescription
FDA approval: 27 Aug 2014
Application: ANDA203139-001

Indications

Warnings and precautions

Use with caution in patients with a history of thromboembolic disease (5.1) .
Fetal Effects: May cause fetal harm. Females of reproductive potential should be advised to avoid becoming pregnant ( 5.2 ).
Clinical cases of 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 in the stressed and non-stressed state (5.3) .
New onset and exacerbation of pre-existing diabetes have been reported (5.4) .

5.1 General

Effects on HIV viral replication have not been determined.
Use with caution in patients with a history of thromboembolic disease.

5.2Fetal Toxicity Based

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 TWi Pharmaceuticals, Inc. at 1-844-518-2989 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Serious 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 )]
Thromboembolic Disease [see Warnings and Precautions ( 5.1 )]
Adrenal Insufficiency [see Warnings and Precautions ( 5.3 )]
Diabetes [see Warnings and Precautions ( 5.4 )]

6.2Clinical 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, 125 mg/mL 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.

6.3Postmarketing Experience

Postmarketing reports associated with megestrol acetate oral suspension include thromboembolic phenomena including thrombophlebitis, deep vein thrombosis, and pulmonary embolism; and glucose intolerance.

Megestrol Acetate

Indications

Contraindications

Warnings and precautions

5.2Fetal Toxicity Based

At a glance

Two medicines in one question?

Megestrol Acetate

Indications

Contraindications

Warnings and precautions

5.2Fetal Toxicity Based

At a glance

Two medicines in one question?

5.3Adrenal Insufficiency

5.4Diabetes

Interactions

7.2Zidovudine and Rifabutin

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary Based

Adverse reactions

6.1Serious and Otherwise Important Adverse Reactions

6.2Clinical Trial Experience

6.3Postmarketing Experience

Composition

Strengths and forms

Official product information