Label Changes for:
Zytiga (abiraterone acetate) Tablets
Changes have been made to the ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Post Marketing Experience
- addition of... Musculoskeletal and Connective Tissue Disorders: myopathy, including rhabdomyolysis.
Effects of Abiraterone on Drug Metabolizing Enzymes
- In a CYP2C8 drug-drug interaction trial in healthy subjects, the AUC of pioglitazone (CYP2C8 substrate) was increased by 46% when pioglitazone was given together with a single dose of 1,000 mg abiraterone acetate. Therefore, patients should be monitored closely for signs of toxicity related to a CYP2C8 substrate with a narrow therapeutic index if used concomitantly with ZYTIGA.
6 ADVERSE REACTIONS
6.2 Post Marketing Experience...addition of non-infectious pneumonitis
- Zytiga can cause fetal harm when administered to a pregnant woman. Zytiga is not indicated for use in women…