Exemestane 25 mg/1
Exemestane · TABLET, FILM COATED · NorthStar Rx LLC
Exemestane is a tablet, film coated containing exemestane at 25 mg/1, taken oral. Manufactured by NorthStar Rx LLC.
Key Facts
- Brand Name
- Exemestane
- Generic Name
- Exemestane
- NDC Code (Product)
72603-329- Manufacturer
- NorthStar Rx LLC
- Strength
- 25 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA216454
- Drug Class
- Aromatase Inhibitor [EPC]
- Marketing Start
- 01/01/2025
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Exemestane tablets are 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 for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets are 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 for completion of a total of five consecutive years of adjuvant hormonal therapy [see Clinical Studies (14.1) ]. 1.2 Advanced Breast Cancer in Postmenopausal Women Exemestane tablets are indicated for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy [see Clinical Studies (14.2) ].
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended Dose: One 25 mg tablet once daily after a meal ( 2.1 ). 2.1 Recommended Dose The recommended dose of exemestane tablets in early and advanced breast cancer is one 25 mg tablet once daily after a meal. 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 for completion of a total of five consecutive years of adjuvant hormonal therapy. the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy. 2.2 Dose Modifications Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. For patients receiving exemestane tablets with a strong CYP 3A4 inducer such as rifampicin or phenytoin, the recommended dose of exemestane tablets is 50 mg once daily after a meal [see Drug Interactions (7) and Clinical Pharmacology (12.3) ].
Contraindications
4 CONTRAINDICATIONS Exemestane tablets are contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients. Patients with a known hypersensitivity to the drug or to any of the excipients ( 4 ).
Drug Interactions
7 DRUG INTERACTIONS Strong CYP 3A4 inducers: Concomitant use of strong CYP 3A4 inducers decreases exemestane exposure. Increase the exemestane tablets dose to 50 mg ( 2.2 , 7 ). Drugs That Induce CYP 3A4 Co-medications that induce CYP 3A4 (e.g., rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's Wort) may significantly decrease exposure to exemestane. Dose modification is recommended for patients who are also receiving a strong CYP 3A4 inducer [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3) ] .
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Reductions in Bone Mineral Density (BMD) [see Warnings and Precautions (5.1) ] Early breast cancer: Adverse reactions occurring in ≥10% of patients in any treatment group (exemestane tablets vs. tamoxifen) were hot flushes (21% vs. 20%), fatigue (16% vs. 15%), arthralgia (15% vs. 9%), headache (13% vs. 11%), insomnia (12% vs. 9%), and increased sweating (12% vs. 10%). Discontinuation rates due to AEs were similar between exemestane tablets and tamoxifen (6% vs. 5%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were exemestane tablets 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: exemestane tablets 0.4%, tamoxifen 0.3% ( 6 , 6.1 ). Advanced breast cancer: 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 tablets and megestrol acetate, respectively ( 6 , 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367…
Frequently Asked Questions
What is Exemestane used for?
Exemestane contains Exemestane. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Exemestane a controlled substance?
Exemestane is not classified as a controlled substance by the DEA.
What is the generic name for Exemestane?
The generic name for Exemestane is Exemestane. There are 3 other brand versions of Exemestane.
What is the NDC code for Exemestane 25 mg/1?
The NDC (National Drug Code) for Exemestane 25 mg/1 is 72603-329, listed by NorthStar Rx LLC.