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Aromasin (exemestane) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.3 Reductions in Bone Mineral Density (BMD)
- risk of osteoporosis added
6 ADVERSE REACTIONS
6.2 Post-Marketing Experiences
- ...include hypersensitivity, paresthesia, cholestatic hepatitis, and acute generalized exanthematous pustulosis, urticaria, and pruritus.
WARNINGS AND PRECAUTIONS
Vitamin D Assessment
- 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 event information to the labeling based on 52 months of median follow-up in study 96-OEXE 031
- addition of information cholestatic hepatitis