The Food and Drug Administration approved on February 1, 2002, a new formulation of Sustiva (efavirenz). Sustiva is a once-daily non-nucleoside reverse transcriptase inhibitor (NNRTI) used in combination treatment for HIV. The new formulation will provide physicians with the option to prescribe one 600 mg Sustiva tablet once daily instead of three 200 mg capsules once daily (as Sustiva has been used since it was approved in September 1998). The manufacturer indicates that the 600 mg tablet is approximately the same size as one Sustiva 200 mg capsule.
Bristol-Myers Squibb Virology believes that the new tablet formulation of Sustiva will help reduce the number of pills people living with HIV have to take. The 600 mg tablet formulation will be available in late February. Bristol-Myers Squibb Virology will continue to manufacture the 200 mg capsules for those who still wish to take Sustiva as three capsules once-daily as part of their combination regimen.
Including the changes in the drug formulation, Bristol-Myers Squibb Virology included new statements in the package insert to be reflective of the NNRTI. The changes in the package insert reflect drug interactions, adverse event information, and precautions.
Note: Sustiva should still not be taken with Hismanal® (astemizole), Propulsid® (cisapride), Versed® (midazolam), Halcion® (triazolam) or ergot derivatives. Sustiva drug interaction information includes the following medications and herbs: St. John's wort, lorazepam, methadone, cetirizine and rifabutin.
To review the revised label insert: www.fda.gov/cder/foi/label/2002/21360lbl.pdf (PDF).