Adult Dosing
HIV-1 infection in treatment-naive and treatment-experienced adults with no darunavir resistance-associated mutations
- 1 tab (800 mg/150mg) PO qd with food
- Administer in conjunction with other antiretroviral agents
NoteTesting before treatment initiation
- HIV genotypic testing is recommended for antiretroviral treatment-experienced patients. Darunavir/cobicistat can be used in protease inhibitor-naive patients but is not recommended in protease inhibitor-experienced patients
- Evaluate estimated CrCl (eCrCl) because cobicistat decreases eCrCl due to inhibition of tubular secretion of creatinine, without affecting actual renal glomerular function
- Coadministration with tenofovir DF: Assess eCrCl, urine glucose, and urine protein at baseline. Avoid use if eCrCl is <70 mL/min
Pediatric Dosing
- Safety, effectiveness, and pharmacokinetics in pediatric patients less than 18 yrs of age have not been established
[Outline]
- Hepatotoxicity: Patients with pre-existing liver function abnormalities, including chronic hepatitis B or C, have an increased risk for hepatic adverse reactions. Monitor liver enzymes before and during treatment. In case of new or worsening liver dysfunction or clinically significant elevation of liver enzymes and/or symptoms (fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) consider interruption or discontinuation of treatment
- Severe skin reactions accompanied by fever and/or increased transaminase levels were reported in 0.4% cases; Stevens-Johnson syndrome was rare (<0.1%); mild-to-moderate rash was reported within first 4 weeks of treatment which resolved with continued dosing; discontinue treatment immediately if severe rash and/or fever, general malaise, fatigue, muscle or joint aches, blister, oral lesions, conjunctivitis, hepatitis, and/or eosinophilia develop
- Although cobicistat may decrease eCrCl and moderately increase serum creatinine without affecting renal glomerular function, for renal safety, monitor patients with increase in serum creatinine of >0.4 mg/dL from baseline
- Coadministration with tenofovir DF is not recommended in patients who have an eCrCl <70 mL/min. Document baseline urine glucose and urine protein; monitor eCrCl, urine glucose, and urine protein during treatment when coadministered with tenofovir DF. Measure serum phosphorus in patients with or at risk for renal impairment when used with tenofovir DF
- Coadministration of darunavir/cobicistat and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended
- Darunavir/cobicistat is not recommended in combination with other antiretroviral drugs that require pharmacokinetic boosting (i.e. another protease inhibitor or elvitegravir) or with products containing darunavir, cobicistat, or ritonavir
- Monitor patients with a known sulfonamide allergy because darunavir contains a sulfa functional group
- New-onset diabetes mellitus, exacerbation of pre-existing diabetes mellitus, and hyperglycemia have been reported during postmarketing surveillance in HIV-infected patients receiving protease inhibitors; however, causal relationships between HIV protease inhibitor therapy and these events have not been established
- Redistribution/accumulation of body fat, including central obesity, dorsocervical fat enlargement (buffalo hump), peripheral wasting, facial wasting, breast enlargement, and “cushingoid appearance” have been reported in patients receiving ART; however, a causal relationship has not been established
- Immune reconstitution syndrome has been reported in patients treated with combination ART; during the initial phase of combination ART, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (e.g. <i>M. avium</i> infection, CMV, PCP, or tuberculosis) which may require further evaluation and treatment; autoimmune disorders (e.g. Graves' disease, polymyositis, and Guillain-Barre syndrome) have also been reported, however, time to onset is variable
- Increased bleeding, including spontaneous skin hematomas and hemarthrosis have been reported in patients with hemophilia type A and B treated with HIV protease inhibitors; however, a causal relationship has not been established
Cautions: Use cautiously in:
- Hypersensitivity to sulfonamides
- Hepatic impairment
- HBV or HCV co-infection
- Diabetes mellitus
- Hemophilia
US Trade Name(s)
US Availability
Prezcobix (darunavir/cobicistat)
Canadian Trade Name(s)
Canadian Availability
Prezcobix (darunavir/cobicistat)
UK Trade Name(s)
UK Availability
Rezolsta (darunavir/cobicistat)
Australian Trade Name(s)
Australian Availability
[Outline]