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Viramune (nevirapine) tablets and oral suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
6 ADVERSE REACTIONS
6.3 Postmarketing Experience
- Extensive revisions to multiple sections of the Medication Guide based on the first assessment of the Viramune (nevirapine) REMS [see revised PI]
WARNING: LIFE-THREATENING (INCLUDING FATAL) HEPATOTOXICITY and SKIN REACTIONS
- HEPATOTOXICITY: However, hepatotoxicity associated with Viramune use can occur in both genders, all CD4+ cell counts and at any time during treatment. Hepatic failure has also been reported in patients without HIV taking Viramune for post-exposure prophylaxis (PEP). Use of Viramune for occupational and nonoccupational PEP is contraindicated.
- Viramune is contraindicated in patients with moderate or severe (Child-Pugh Class B or C, respectively) hepatic impairment.
- Viramune is contraindicated for use as part of occupational and non-occupational post-exposure prophylaxis (PEP) regimens.
WARNINGS and PRECAUTIONS
- In addition, serious hepatotoxicity (including liver failure requiring transplantation in one instance) has been reported in HIV-1 uninfected individuals receiving multiple doses of Viramune in the setting of post-exposure prophylaxis (PEP), an unapproved use. Use of Viramune for occupational and non-occupational PEP is contraindicated.
- Concomitant use of St. John's wort (Hypericum perforatum) or St. John's wort-containing products and Viramune is not recommended. Co-administration of St. John’s wort with non-nucleoside reverse transcriptase inhibitors (NNRTIs), including Viramune, is expected to substantially decrease NNRTI concentrations and may result in sub-optimal levels of Viramune and lead to loss of virologic response and possible resistance to Viramune or to the class of NNRTIs. Coadministration of Viramune and efavirenz is not recommended as this combination has been associated with an increase in adverse reactions and no improvement in efficacy.