Label Changes for:
Prograf (tacrolimus) Capsules and Injection
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- Use with CYP3A4 Inhibitors and Inducers Including Those That Prolong QT When coadministering tacrolimus with other substrates and/or inhibitors of CYP3A4 that also have the potential to prolong the QT interval, a reduction in tacrolimus dose, close monitoring of tacrolimus whole blood concentrations, and monitoring for QT prolongation is recommended. Use of tacrolimus with amiodarone has been reported to result in increased tacrolimus whole blood concentrations with or without concurrent QT prolongation.
- ….Whole blood concentrations of tacrolimus are markedly increased when coadministered with telaprevir or with boceprevir.
Postmarketing Adverse Reactions
- hemolytic anemia