Label Changes for:
Sustiva (efavirenz) capsules and tablets
September 2009
Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2009
WARNINGS and PRECAUTIONS
- postmarketing reports of contraceptive failure in a few patients who were treated with efavirenz while on an implantable hormonal contraceptive
- interaction of immunosuppressants metabolized by CYP3A4 (cyclosporine, sirolimus, tacrolimus) and inducers of the CYP3A4 isozyme
CLINICAL PHARMACOLOGY
Drug Interaction
- The results of the two drug-drug interaction studies
- efavirenz with atazanavir, a protease inhibitor of HIV-1
- efavirenz with an oral contraceptive
PATIENT PACKAGE INSERT
The following medicines may need to be replaced with another medicine when taken with Sustiva
- Reyataz
The following medicines may require a change in the dose of either Sustiva or other medicine
- The immunosuppressant medicines cyclosporine (Gengraf, Neoral, Sandimmune and others) Prograf (tacrolimus) and Rapamune (sirolimus)
