WARNINGS AND PRECAUTIONS

• Hepatotoxicity: Fatal and non-fatal hepatotoxicity has been reported.
• Clinical Hepatitis or transaminase elevations combined with rash to form other symptoms.
• Fatal and non-fatal skin reactions and hypersensitivity may occur.
• Monitor patients for immune reconstitution syndrome and fat redistribution.
• Co-administration of Nevirapine 200mg can alter the concentration of other drugs and other drugs may alter the concentration of Nevirapine. One form of Nevirapine tablets should be taken at a time and the drug should be consumed regularly without any break.
• Patients with signs or symptoms of hepatitis must be advised to discontinue Nevimune and immediately seek medical evaluation, which should include liver function tests.
• If you take birth control pills, you should not rely on them to prevent pregnancy. They may not work if you take Nevimune. Talk with your doctor about other types of birth control that you can use.
• During the initial months of treatment, patients should be checked skin rash and liver problems.
• The U.S. FDA recommends close monitoring during the first 6 weeks of therapy for the above symptoms as there is high risk during this time. Continued monitoring is recommended for up to the first 18 weeks of treatment. If any patient observes hepatitis plus rash or other any systemic signs or symptoms, or skin rash or severe hypersensitivity, Nevirapine should not be initiated.