Drug Interaction:
Drugs metabolised by CYP3A4 that have narrow therapeutic ratio, oestrogens
Indication:
Adjuvant treatment of postmenopausal oestrogen receptor positive invasive breast cancer
Advanced postmenopausal breast cancer that has progressed following anti-oestrogen therapy
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1,Exemestane Anti-cancer 18-10-2001
2.Exemestane 25mg tablet 29-08-2009
Addl.Indication
Indicated for adjuvant treatment of post-menopausal women with estrogen
receptor positive early Breast Cancer who have received two-three Year
of Tamoxifen and are switched to Exemastane for completion of total
Five Years of Adjuvant Hormonal Therapy
Adverse Reaction:
Hot flushes, nausea, arthalgia, fatigue, carpal funnel syndrome,
sweating, dizziness, headache, pain, rash, abdominal pain
Depression, anxiety, alopecia, breathlessness, leg and pripheral oedema,
dyspepsia, constipation, hypertension, fever.
Osteoporosis, fracture, hepatitis, thrombocytopenia, leucopenia, lymphopaenia,
Increased LFTs
Rarely, blood syscrasias
Contra-Indications:
Premenopausal women
Pregnancy
Lactation
Special Precautions-
Assess LH , FSH, ans ostridiol levels prior to treatment
Hepatic or renal impairment
Monitor bone marrow density during adjuvant therapy
Treat for osteoporosis as appropiate.
Liver, bone metastases
Dosages/ Overdosage Etc:
Adjuvant treatment of postmenopausal oestrogen receptor positive invasive breast cancer
Advanced postmenopausal breast cancer that has progressed following anti-oestrogen therapy
1 tablet daily after meals
In early breast cancer, continue treatment until completion 5 years combined sequential adjuvant
therapy with tamoxifen or earlier if tumor relapses.
In advanced breast cancer continue treatment until tumor progression is evident
Children- not applicable
Pregnancy and lactation:
Contraindicated for use during pregnancy and lactation