Discontinue immediately if signs or symptoms of severe skin or hypersensitivity reactions develop. Additional monitoring in patients w/ pre-existing liver dysfunction or co-infection w/ HBV &/or HCV; increased risk of CV events. Caution in patients w/ hepatic impairment; elderly. Perform appropriate laboratory testing including ALT, AST & bilirubin, prior to treatment initiation & at other time points during treatment as clinically indicated. Consider discontinuation in any patient w/ signs or symptoms of hepatitis, or w/ increased liver transaminases combined w/ rash or other systemic symptoms. Increased risk of postural hypotension in patients w/ severe renal insufficiency or w/ ESRD. Reports of immune reconstitution syndrome. Potential risk of infection or malignancy. Pregnancy. Mothers should not breastfeed if taking Celsentri. Should not be used in ped patients. Not recommended in patients w/ dual/mixed- or CXCR4-tropic HIV-1.