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New Viramune (nevirapine) Safety Information
Here is link to full test report from FDA’s Viramune Product Insert:
Re: Clarification of risk factors for severe, life-threatening and fatalhepatotoxicity with VIRAMUNE (nevirapine)
Dear Health Care Professional:
Boehringer Ingelheim Pharmaceuticals Inc. (BIPI) is writing to inform youof important new labeling information being added to the Boxed Warningfor VIRAMUNE, a non-nucleoside reverse transcriptase inhibitorindicated for the treatment of HIV-1 infection in combination with otherantiretroviral agents. Specifically, we wish to draw your attention to thefollowing:
--Women with CD4+ counts >250 cells/mm3, including pregnantwomen receiving chronic treatment for HIV infection, are atconsiderably higher risk (12 fold) of hepatotoxicity. Some of theseevents have been fatal. This subset of patients was identified byanalyses of CD4 count at the time of initiation of VIRAMUNEtherapy.
--The greatest risk of severe and potentially fatal hepatic events (oftenassociated with rash) occurs in the first 6 weeks of VIRAMUNEtreatment. However, the risk continues after this time and patientsshould be monitored closely for the first 18 weeks of treatment withVIRAMUNE.
--In some cases hepatic injury progresses despite discontinuation oftreatment. This new information is the result of recent post-marketing surveillance data and further analysis of the VIRAMUNE clinical trial database.
Although this new information describes patients at increased risk, it is important to note that any patient can experience hepatic events and should be monitored carefully. As is already described in the product labeling for VIRAMUNE, some experts recommend clinical and laboratory monitoring more often than once a month, and in particular would include monitoring of liver function tests at baseline, at the time of dose escalation, and two weeks after dose escalation. All patients developing a rash, at any time during VIRAMUNE treatment, but particularly during the first 18weeks, should have liver function tests performed at that time. After the initial 18 week period, frequent clinical and laboratory monitoring should continue throughout VIRAMUNE treatment.
It is important to counsel all patients that if signs or symptoms of hepatitis, severe skin reactions or hypersensitivity reactions occur, they should discontinue VIRAMUNE treatment and seek medical evaluation immediately. VIRAMUNE should not be restarted in these patients.
You can assist us in monitoring the safety of VIRAMUNE by reporting adverse reactions to the Drug Information Unit at Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257, OPTION#4, by FAX at 1-800-821-7119 or via e-mail at druginfo@rdg.boehringer-ingelheim.com.
Alternatively, you can contact the FDA MedWatch program by telephone at 1-800-332-1088, by FAX at 1-800-332-0178, via www.FDA.gov/medwatch, or by mail to MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 30857.
A copy of the newly revised package insert is enclosed with this letter for your review. Also included are Guidelines for the Management of Hepatic and Rash Events with VIRAMUNE, as an additional tool to assist you in managing these events.
Kirk V. Shepard, M.D.
Vice President, Clinical & Scientific Affairs
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