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Juxtapid (Lomitapide) Capsules
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
WARNINGS AND PRECAUTIONS
Risk of Hepatotoxicity
- …Juxtapid has not been studied concomitantly with other LDL-lowering agents that can also increase hepatic fat. Therefore, the combined use of such agents is not recommended.