Aromasin (exemestane) tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) –
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