Important Safety Information: Exemestane Tablets
What is this?
This Important Safety Information summarizes key warnings and precautions for Exemestane, an oral aromatase inhibitor used in postmenopausal women for certain types of estrogen-receptor positive breast cancer. Exemestane is FDA-approved and is indicated for:
• Adjuvant treatment of postmenopausal women with early breast cancer after 2 to 3 years of tamoxifen therapy
• Treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy
Exemestane should only be used exactly as prescribed by a licensed healthcare provider. This summary does not include all available information. Please see full Prescribing Information at . Always read the Patient Information and follow your provider’s instructions.
Most Serious Warnings
Exemestane can cause:
Reduction in bone mineral density (BMD), increasing risk of osteoporosis and fractures
Embryo-fetal toxicity and potential harm to an unborn baby
Severe allergic reactions (hypersensitivity)
Cardiovascular events including myocardial infarction, cardiac ischemia, or cardiac failure
Liver problems including hepatitis or cholestatic hepatitis
Who Should NOT Take Exemestane
Do not take this medication if you:
Have a known hypersensitivity to exemestane or any ingredient in the formulation
Are pregnant
Are premenopausal (still having menstrual periods)
Before Taking Exemestane, Tell Your Healthcare Provider if You:
Have osteoporosis or are at risk for bone loss
Have low vitamin D levels
Have liver or kidney problems
Have a history of cardiovascular disease
Are pregnant, planning pregnancy, or breastfeeding
Take estrogen-containing medications, including hormone replacement therapy or certain birth control products
Take medications that strongly induce CYP 3A4 (such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John’s wort)
Possible Side Effects
Common (in early breast cancer):
Hot flashes
Fatigue
Joint pain (arthralgia)
Headache
Insomnia
Increased sweating
Common (in advanced breast cancer):
Hot flashes
Nausea
Fatigue
Increased sweating
Increased appetite
Serious (seek medical care immediately):
Chest pain or symptoms of heart attack
Shortness of breath
Signs of blood clots
Severe allergic reaction including rash, swelling, or difficulty breathing
Yellowing of the skin or eyes
Severe bone pain or fracture
Bone Health
Exemestane lowers estrogen levels, which may lead to bone loss over time. Your healthcare provider may assess bone mineral density before and during treatment and may recommend calcium or vitamin D supplementation if appropriate.
Pregnancy and Lactation
Exemestane can cause fetal harm when given during pregnancy. Females of reproductive potential should use effective contraception during treatment and for 1 month after the final dose.
Do not breastfeed during treatment and for 1 month after the last dose.
Drug Interactions
Strong CYP 3A4 inducers may decrease exemestane levels. Dose adjustment may be required. Exemestane should not be taken with estrogen-containing agents, as they may reduce its effectiveness.
Storage
Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Keep out of reach of children.
Overdose
There is no specific antidote. Treatment is supportive and symptomatic. In case of overdose, seek emergency medical care.
Disclaimer
This summary does not include all information about Exemestane Tablets and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment recommendations. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.
