ABACAVIR-LAMIVUDINE

Warning and Precautions

• Prior to initiating treatment with abacavir lamivudine combination medicine, screen for the HLA-B*5701 allele because of abacavir.
• Use of Abacavir Lamivudine is restricted in patients who have the HLA-B*5701 allele, with prior hypersensitivity reaction to abacavir or lamivudine, with moderate or severe hepatic impairment.
• Serious and sometimes fatal hypersensitivity reactions may occur. These reactions included multi-organ failure and anaphylaxis and typically occur within the first 6 weeks of treatment with abacavir; although abacavir hypersensitivity reactions may occur any time during treatment.
• Clinical and laboratory evidence of exacerbations of hepatitis may occur after discontinuation of lamivudine. Patients should be precisely monitored with both clinical and laboratory follow-up for at least some months after stopping treatment.
• Suspend treatment with Abacavir Lamivudine in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity, which may include hepatomegaly and steatosis even in the absence of marked transaminase elevations.
• Instruct women with HIV-1 infection not to breastfeed while taking treatment with abacavir lamivudine 600 mg / 300 mg because HIV-1 can be passed to the baby in breast milk.