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FDA Updates Product Labeling for Sustiva (Efavirenz)
 
 
  The Food and Drug Administration recently approved revisions to the package insert for Sustiva (efavirenz), a non-nucleoside reverse transcriptase inhibitor, for both capsules and tablets
 
As of July 2009, the Antiretroviral Pregnancy Registry has received prospective reports of 661 pregnancies exposed to efavirenz-containing regimens, nearly all of which were first trimester exposures (606 pregnancies). Birth defects occurred in 14 of 501 live births (first trimester exposure) and 2 of 55 live births (second/third-trimester exposure).
 
Monitoring of liver enzymes before and during treatment is recommended for patients with underlying hepatic disease, including hepatitis B or C infection; patients with marked transaminase elevations; and patients treated with other medications associated with liver toxicity. Liver enzyme monitoring should also be considered for patients without pre-existing hepatic dysfunction or other risk factors.
 
Posaconazole: Avoid concomitant use unless the benefit outweighs the risks[.] Maraviroc: Refer to the full prescribing information for maraviroc for guidance on coadministration with efavirenz.
 
Because of the extensive cytochrome P450-mediated metabolism of efavirenz and limited clinical experience in patients with hepatic impairment, caution should be exercised in administering Sustiva to these patients
 
Some patients taking Sustiva have experienced serious liver problems including liver failure resulting in transplantation or death. Most of these serious side effects occurred in patients with a chronic liver disease such as hepatitis infection, but there have also been a few reports in patients without any existing liver disease.
 
The complete revised label is available at the FDA Web site.
More information is available:
FDA: Press release
AIDSinfo: Sustiva (efavirenz) fact sheet
 
 
 
 
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