Regulatory Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
Therapeutic
Prescription Only
Formulation Information
TABLET, FILM COATED
**4.2. Posology and Method of Administration** Adult and Elderly Patients The recommended dose of exemestane is one 25 mg tablet to be taken once daily, preferably after a meal. In patients with early breast cancer, treatment with exemestane should continue until completion of five years of combined sequential adjuvant hormonal therapy (tamoxifen followed by exemestane), or earlier if tumor relapse occurs. In patients with advanced breast cancer, treatment with exemestane should continue until tumor progression is evident. Hepatic or Renal Insufficiency No dose adjustments are required for patients with hepatic or renal insufficiency. Children Not recommended for use in children.
ORAL
Medical Information
**4.1. Therapeutic Indications** Exemestane is indicated for the adjuvant treatment of post-menopausal women with estrogen-receptor positive invasive early breast cancer, following 2–3 years of initial adjuvant tamoxifen therapy. Exemestane is indicated for the treatment of advanced breast cancer in women with natural or induced post-menopausal status whose disease has progressed following anti-estrogen therapy.
**4.3. Contraindications** Exemestane is contraindicated in patients with a known hypersensitivity to the drug or to any of the excipients.
L02BG06
exemestane
Manufacturer Information
TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.
S.C. SINDAN-PHARMA S.R.L.
Active Ingredients
Documents
Package Inserts
Aromastan Tablet PI.pdf
Approved: December 10, 2021