COMBIVIR: Important Safety Information

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported
Zidovudine has been associated with hematologic toxicity including neutropenia and severe anemia, especially in advanced HIV disease, and with symptomatic myopathy after prolonged use
Severe acute exacerbations of hepatitis B have been reported in patients who are co-infected with hepatitis B virus (HBV) and HIV and have discontinued lamivudine, which is one component of COMBIVIR. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue COMBIVIR and are co-infected with HIV and HBV. If appropriate, initiation of anti-hepatitis B therapy may be warranted
Hepatic decompensation (some fatal) has occurred in HIV/HCV co-infected patients receiving combination antiretroviral therapy for HIV and interferon with or without ribavirin. Patients receiving interferon with or without ribavirin and COMBIVIR should be closely monitored for treatment-associated toxicities, especially hepatic decompensation, neutropenia, and anemia. Discontinuation of COMBIVIR should be considered as medically appropriate
Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including COMBIVIR. During the initial phase of combination antiretroviral treatment, patients whose immune system responds may develop an inflammatory response to indolent or residual opportunistic infections (such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis), which may necessitate further evaluation and treatment
Redistribution/accumulation of body fat has been observed in patients receiving antiretroviral therapy. The causal relationship, mechanism, and long-term consequences of these events are currently unknown
Most frequent adverse events are headache (35%), nausea (33%), malaise/fatigue (27%), and nasal signs and symptoms (20%)

Important Safety Information for Healthcare Professionals