May cause fat redistribution. Patients may develop immune reconstitution syndrome resulting in occurrence of inflammatory response to indolent or residual opportunistic infection. Changes in glucose tolerance, hyperglycemia, exacerbation of diabetes, DKA, and new-onset diabetes mellitus reported in patients receiving protease inhibitors. Use with caution in hemophilia A or B (increased bleeding during protease inhibitor therapy reported). May cause hepatitis and/or exacerbate pre-existing hepatic dysfunction (use with caution in underlying hepatic disease, such as hepatitis B or C or cirrhosis; use not recommended with moderate-to-severe impairment). Use with caution in patients taking strong CYP3A4 inhibitors, moderate or strong CYP3A4 inducers and major CYP3A4 substrates. Not recommended for use with rifampin, St. John’s wort, lovastatin, simvastatin, phosphodiesterase-5 inhibitors, or proton pump inhibitors (based on omeprazole data). Formulation contains phenylalanine.