Label Changes for:
Juxtapid (lomitapide) Capsules
Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
- * re-categorize the combination of tipranavir/ritonavir from the list of weak CYP3A4 inhibitors to the list of strong CYP3A4 inhibitors.*
8 USE IN SPECIFIC POPULATIONS
- Pregnancy Exposure Registry…added
17 PATIENT COUNSELING INFORMATION
- Phone number added for registry program
2. Harm to your unborn baby.
- If you become pregnant while taking JUXTAPID, stop taking JUXTAPID and call your doctor right away.
- Pregnancy Exposure Registry…section added