Label Changes for:
Astagraf XL (tacrolimus extended-release capsules)
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)
5 WARNINGS AND PRECAUTIONS
5.14 Use with CYP3A4 Inhibitors and Inducers
5.15 QT Prolongation …added section
5.18 Gastrointestinal Perforation …added section
6 ADVERSE REACTIONS
- Added bullet point…Gastrointestinal Perforation [see Warnings and Precautions (5.18)]
7 DRUG INTERACTIONS
- Dose adjustments may be needed along with frequent monitoring of tacrolimus whole blood trough concentrations when ASTAGRAF XL is administered with CYP3A inhibitors or inducers. In addition, patients should be monitored for adverse reactions including changes in renal function and QT prolongation [see Warnings and Precautions (5.9) and (5.15)].