Important New Safety Information
Re: Clarification of Risk Factors for Severe, Life-Threatening and Fatal Hepatotoxicity With Viramune® (Nevirapine)
Dear Health Care Professional:
Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) is writing to inform you of important new labeling information being added to the Boxed Warning for Viramune, a non-nucleoside reverse transcriptase inhibitor (Non-Nuke) indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents. Specifically, we wish to draw your attention to the following:
Women with CD4+ counts >250 cells/mm3, including pregnant women receiving chronic treatment for HIV infection are at considerably higher risk (12 fold) of hepatotoxicity. Some of these events have been fatal. This subset of patients was identified by analyses of CD4 count at the time of initiation of Viramune therapy.
The greatest risk of severe and potentially fatal hepatic events (often associated with rash) occurs in the first 6 weeks of Viramune treatment. However, the risk continues after this time and patients should be monitored closely for the first 18 weeks of treatment with Viramune. In some cases, hepatic injury progresses despite discontinuation of treatment.
This new information is the result of recent post-marketing surveillance data and further analysis of the Viramune clinical trial database.
Special Advisory Note From the STEP Ezine Editor
If you are taking Viramune (nevirapine) and you believe the above description fits you, call your doctor. Please do not discontinue taking this anti HIV medication unless advised by your health care provider.
(The word "hepatic" refers to the liver.)