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Exemestane
Overview
What is Exemestane?
Exemestane Tablets for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is CHO and its structural formula is as follows:
The active ingredient is a white to slightly yellow powder with a molecular weight of 296.41. Exemestane is freely soluble in tetrahydrofuran and dimethylformamide; soluble in acetone, acetonitrile, methanol, and ethyl acetate; sparingly soluble in ethanol; very slightly soluble in nhexane and insoluble in water.
Each Exemestane Tablet contains the following inactive ingredients: mannitol, copovidone, crospovidone, silicified microcrystalline cellulose, sodium starch glycolate, magnesium stearate, titanium dioxide, polyethylene glycol 400, and hypromellose.
What does Exemestane look like?
What are the available doses of Exemestane?
Tablets: 25 mg ().
What should I talk to my health care provider before I take Exemestane?
How should I use Exemestane?
What interacts with Exemestane?
Sorry No Records found
What are the warnings of Exemestane?
Sorry No Records found
What are the precautions of Exemestane?
Sorry No Records found
What are the side effects of Exemestane?
Sorry No records found
What should I look out for while using Exemestane?
Exemestane Tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.
What might happen if I take too much Exemestane?
Clinical trials have been conducted with exemestane given as a single dose to healthy female volunteers at doses as high as 800 mg and daily for 12 weeks to postmenopausal women with advanced breast cancer at doses as high as 600 mg. These dosages were well tolerated. There is no specific antidote to overdosage and treatment must be symptomatic. General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.
A male child (age unknown) accidentally ingested a 25-mg tablet of exemestane. The initial physical examination was normal, but blood tests performed 1 hour after ingestion indicated leucocytosis (WBC 25000/mm with 90% neutrophils). Blood tests were repeated 4 days after the incident and were normal. No treatment was given.
In mice, mortality was observed after a single oral dose of exemestane of 3200 mg/kg, the lowest dose tested (about 640 times the recommended human dose on a mg/m basis). In rats and dogs, mortality was observed after single oral doses of exemestane of 5000 mg/kg (about 2000 times the recommended human dose on a mg/m basis) and of 3000 mg/kg (about 4000 times the recommended human dose on a mg/m basis), respectively.
Convulsions were observed after single doses of exemestane of 400 mg/kg and 3000 mg/kg in mice and dogs (approximately 80 and 4000 times the recommended human dose on a mg/m basis), respectively.
How should I store and handle Exemestane?
Store at 59° to 77°F (15° to 25°C) and protect from light. Dispense in tight, light-resistant containers.Exemestane Tablets are white to off-white, round compound cup tablet with “25” on one side and plain on the reverse. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets.30-tablet HDPE bottle NDC 47781-108-30Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Exemestane Tablets are white to off-white, round compound cup tablet with “25” on one side and plain on the reverse. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets.30-tablet HDPE bottle NDC 47781-108-30Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].Exemestane Tablets are white to off-white, round compound cup tablet with “25” on one side and plain on the reverse. Exemestane tablets are packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets.30-tablet HDPE bottle NDC 47781-108-30Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Breast cancer cell growth may be estrogen-dependent. Aromatase is the principal enzyme that converts androgens to estrogens both in pre- and postmenopausal women. While the main source of estrogen (primarily estradiol) is the ovary in premenopausal women, the principal source of circulating estrogens in postmenopausal women is from conversion of adrenal and ovarian androgens (androstenedione and testosterone) to estrogens (estrone and estradiol) by the aromatase enzyme in peripheral tissues.
Exemestane is an irreversible, steroidal aromatase inactivator, structurally related to the natural substrate androstenedione. It acts as a false substrate for the aromatase enzyme, and is processed to an intermediate that binds irreversibly to the active site of the enzyme, causing its inactivation, an effect also known as “suicide inhibition.” Exemestane significantly lowers circulating estrogen concentrations in postmenopausal women, but has no detectable effect on adrenal biosynthesis of corticosteroids or aldosterone. Exemestane has no effect on other enzymes involved in the steroidogenic pathway up to a concentration at least 600 times higher than that inhibiting the aromatase enzyme.
Non-Clinical Toxicology
Exemestane Tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.In the adjuvant treatment of early breast cancer, the most common adverse reactions occurring in ≥10% of patients in any treatment group (exemestane vs. tamoxifen) were mild to moderate hot flushes (21.2% vs. 19.9%), fatigue (16.1% vs. 14.7%), arthralgia (14.6% vs. 8.6%), headache (13.1% vs. 10.8%), insomnia (12.4% vs. 8.9%), and increased sweating (11.8% vs. 10.4%). Discontinuation rates due to AEs were similar between exemestane and tamoxifen (6.3% vs. 5.1%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were exemestane 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: exemestane 0.4%, tamoxifen 0.3%.
In the treatment of advanced breast cancer, the most common adverse reactions were mild to moderate and included hot flushes (13% vs. 5%), nausea (9% vs. 5%), fatigue (8% vs. 10%), increased sweating (4% vs. 8%), and increased appetite (3% vs. 6%) for exemestane and megestrol acetate, respectively.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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