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Results of in vitro studies showed a weak antagonism of nevirapine by adefovirsee section 5.1this has not been confirmed in clinical trials and reduced efficacy is not expectedAdefovir did not influence any of the common CYP isoforms known to be involved in human drug metabolism and is excreted renallyNo clinically relevant drug-drug interaction is expected.

The safety and efficacy of Viramune has not been established in patients with significant underlying liver disordersViramune is contraindicated in patients with severe hepatic impairmentChild-Pugh Csee section 4.3Pharmacokinetic results suggest caution should be exercised when nevirapine is administered to patients with moderate hepatic dysfunctionChild-Pugh BPatients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactionsIn the case of concomitant antiviral therapy for hepatitis B or Cplease refer also to the relevant product information for these medicinal products.

Limited human data are insufficient to determinerisk of infertility in humansbased on results from animal fertility studies conducted in ratstherapy may reduce fertility in females of reproductive potentialnot known if these effects on fertility are reversible.

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