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)
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