Lamivudine is an antiretroviral agent.

EPIVIR is a nucleoside analogue reverse transcriptase inhibitor indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Limitations of Use: The dosage of this product is for HIV-1 and not for HBV.

• Adults: 300 mg daily, administered as either 150 mg twice daily or 300 mg once daily.
• Pediatric Patients Aged 3 Months and Older: Administered either once or twice daily. The dose should be calculated on body weight (kg) and should not exceed 300 mg daily.
• Patients with Renal Impairment: Doses of EPIVIR must be adjusted in accordance with renal function.

• The most common reported adverse reactions (incidence greater than or equal to 15%) in adults were headache, nausea, malaise and fatigue, nasal signs and symptoms, diarrhea, and cough.
• The most common reported adverse reactions (incidence greater than or equal to 15%) in pediatric subjects were fever and cough.

EPIVIR is contraindicated in patients with previous hypersensitivity reactions to lamivudine.

• Co-infected HIV-1/HBV Patients: Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported.
• Hepatic decompensation, some fatal, has occurred in HIV-1/HCV co-infected patients receiving interferon and ribavirin-based regimens. Monitor for treatment-associated toxicities. Discontinue EPIVIR as medically appropriate and consider dose reduction or discontinuation of interferon alfa, ribavirin, or both.
• Pancreatitis: Use with caution in pediatric patients with a history of pancreatitis or other significant risk factors for pancreatitis. Discontinue treatment as clinically appropriate.
• Immune reconstitution syndrome and redistribution/accumulation of body fat have been reported in patients treated with combination antiretroviral therapy. See package insert for complete information.