Darunavir/Cobicistat

Hepatotoxicity reported; monitor liver enzymes at baseline and during treatment; consider interrupting or discontinuing treatment with evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms [eg, fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly])

Severe skin reactions accompanied by fever and/or elevations of transaminases; Stevens-Johnson syndrome rarely; mild-to-moderate rash reported to occur within first 4 weeks of treatment and resolved with continued dosing

Assess eCrCl before initiating therapy; cobicistat decreases estimated creatinine clearance without affecting actual renal glomerular function by inhibiting tubular secretion of creatinine

Sulfa allergy: Darunavir contains a sulfa moiety; monitor patients with a known sulfonamide allergy

New-onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia reported during postmarketing surveillance in HIV-infected patients receiving protease inhibitors

Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and cushingoid appearance have been observed in patients receiving ARTs

Increased bleeding, including spontaneous skin hematomas and hemarthrosis, reported in patients with hemophilia type A and B treated with HIV protease inhibitors

Not recommended for use in pregnant women because of substantially lower exposures of darunavir and cobicistat during pregnancy