Brand Name
Aromasin
Generic Name
Exemestane
View Brand Information FDA approval date: October 21, 1999
Classification: Aromatase Inhibitor
Form: Tablet
What is Aromasin (Exemestane)?
Exemestane is an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets, USP for completion of a total of five consecutive years of adjuvant hormonal therapy ( 1.
Approved To Treat
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Brand Information
Aromasin (exemestane)
1DOSAGE FORMS AND STRENGTHS
AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black.
2CONTRAINDICATIONS
AROMASIN is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Reductions in Bone Mineral Density (BMD)
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates 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 clinical practice.
3.2Postmarketing Experience
The following adverse reactions have been identified during post approval use of AROMASIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Immune system disorders- hypersensitivity
Hepatobiliary disorders- hepatitis including cholestatic hepatitis
Nervous system disorders- paresthesia
Musculoskeletal and connective tissue disorder- tendon disorders including tendon rupture, tendonitis, and tenosynovitis
Skin and subcutaneous tissue disorders- acute generalized exanthematous pustulosis, urticaria, pruritus
4OVERDOSAGE
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
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
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
5DESCRIPTION
AROMASIN® 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 C
The active ingredient is a white to slightly yellow crystalline powder with a molecular weight of 296.41. Exemestane is freely soluble in N, N-dimethylformamide, soluble in methanol, and practically insoluble in water.
Each AROMASIN Tablet contains the following inactive ingredients: mannitol, crospovidone, polysorbate 80, hypromellose, colloidal silicon dioxide, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, simethicone, polyethylene glycol 6000, sucrose, magnesium carbonate, titanium dioxide, methylparaben, and polyvinyl alcohol.
6HOW SUPPLIED/STORAGE AND HANDLING
AROMASIN Tablets are round, biconvex, and off-white to slightly gray. Each tablet contains 25 mg of exemestane. The tablets are printed on one side with the number "7663" in black.
AROMASIN is packaged in HDPE bottles with a child-resistant screw cap, supplied in packs of 30 tablets.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
8PRINCIPAL DISPLAY PANEL - 25 mg Tablet Bottle Label
NDC 0009-7663-04
Aromasin®
exemestane tablets
exemestane tablets
25 mg
30 Tablets
Rx only
