Active Ingredient: Cobicistat
Cobicistat is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir in combination with other antiretroviral agents in the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 35 kg coadministered with atazanavir or 40 kg coadministered with darunavir.
Limitations of Use:
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 150 milligrams cobicistat, once daily to meals.
Administer cobicistat in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of adults with HIV-1 infection. The recommended dosages of cobicistat and atazanavir or darunavir given with food are presented in Table 1. Cobicistat must be coadministered at the same time as atazanavir or darunavir. Consult the prescribing information for atazanavir or darunavir.
Table 1. Recommended Dosing Regimens in Treatment-Naïve or Treatment-Experienced Adults:
| Cobicistat Dosage | Coadministered Agent Dosage | Patient Populations |
|---|---|---|
| 150 mg orally once daily | atazanavir 300 mg orally once daily | Treatment-naïve or treatment-experienced |
| darunavir 800 mg orally once daily | Treatment-naïve or treatment-experienced with no darunavir resistance-associated substitutions |
Administer cobicistat in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of pediatric patients with HIV-1 infection. The recommended dosages of cobicistat and atazanavir or darunavir given with food are based on weight and presented in Table 2. Cobicistat must be coadministered at the same time as atazanavir or darunavir. Consult the prescribing information for atazanavir or darunavir.
Table 2. Recommended Dosing Regimens in Treatment-Naïve or Treatment-Experienced Pediatric Patients:
| Cobicistat Dosage | Coadministered Agent Dosage | Patient Populations and Weight |
|---|---|---|
| 150 mg orally once daily | atazanavir 300 mg orally once daily | Treatment-naïve or treatment-experienced weighing at least 35 kg |
| darunavir 800 mg orally once daily | Treatment-naïve or treatment-experienced with no darunavir resistance-associated substitutions weighing at least 40 kg |
Prior to or when initiating cobicistat and during treatment with cobicistat, on a clinically appropriate schedule, assess estimated creatinine clearance because cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function. When coadministering cobicistat with TDF, assess estimated creatinine clearance, urine glucose, and urine protein at baseline. In patients with chronic kidney disease, also assess serum phosphorus.
It should be taken with food.
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