May cause fat redistribution. Severe hepatotoxic reactions may occur (fulminant and cholestatic hepatitis, hepatic necrosis) and in some cases, resulted in hepatic failure and death. Patients with history of chronic hepatitis (B or C) or increased baseline transaminase levels may be at increased risk of hepatotoxic reactions. Female gender and patients with increased CD4^+^-cell counts may be at substantially greater risk of hepatic events (often associated with rash). Patients may develop immune reconstitution syndrome resulting in occurrence of inflammatory response to indolent or residual opportunistic infection; further evaluation and treatment may be required. Rhabdomyolysis occurred in conjunction with skin and/or hepatic adverse events during postmarketing surveillance. Termination of therapy warranted with evidence of severe skin or liver toxicity. Severe life-threatening skin reactions (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis, hypersensitivity reactions with rash and organ dysfunction) occurred. Use with caution in patients taking strong CYP3A4 inhibitors, moderate or strong CYP3A4 inducers and major CYP3A4 substrates.