Indications & Dose:

Adjuvant Treatment of Postmenopausal Women, Advanced Breast Cancer in Postmenopausal Women

DOSAGE AND ADMINISTRATION

The recommended dose of AROMASIN 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 AROMASIN 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.

Contraindications:

Hypersensitivity, Pregnancy

Cautions:

Precautions:

Interaction:

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

Warnings:

AROMASIN should not be coadministered with estrogen-containing agents as these could interfere with its pharmacologic action. Routine assessment of 25-hydroxy vitamin D levels prior to the start of aromatase inhibitor treatment should be performed, due to the high prevalence of vitamin D deficiency in women with early breast cancer (EBC). Women with vitamin D deficiency should receive supplementation with vitamin D.

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

AROMASIN was generally well tolerated and adverse events were usually mild to moderate. In the adjuvant treatment of early breast cancer, adverse events occurring in ?10% of patients in any treatment group (AROMASIN vs. tamoxifen) were 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 AROMASIN and tamoxifen (6.3% vs. 5.1%). Incidences of cardiac ischemic events (myocardial infarction, angina, and myocardial ischemia) were AROMASIN 1.6%, tamoxifen 0.6%. Incidence of cardiac failure: AROMASIN 0.4%, tamoxifen 0.3%. In the treatment of advanced breast cancer, the most common adverse events 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 AROMASIN and megestrol acetate, respectively.

Patient And Carer Advice: