Drug Detail:Tybost (Cobicistat [ koe-bik-i-stat ])
Generic Name: COBICISTAT 150mg
Dosage Form: tablet, film coated
Drug Class: Antiviral boosters
Recommended Dosage in Adults
Administer TYBOST in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of adults with HIV-1 infection. The recommended dosages of TYBOST and atazanavir or darunavir given with food are presented in Table 1. TYBOST must be coadministered at the same time as atazanavir or darunavir [see Drug Interactions (7)]. Consult the prescribing information for atazanavir or darunavir.
| TYBOST 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 |
Recommended Dosage in Pediatric Patients
Administer TYBOST in conjunction with atazanavir or darunavir and other antiretroviral agents in the treatment of pediatric patients with HIV-1 infection. The recommended dosages of TYBOST and atazanavir or darunavir given with food are based on weight and presented in Table 2. TYBOST must be coadministered at the same time as atazanavir or darunavir [see Drug Interactions (7)]. Consult the prescribing information for atazanavir or darunavir.
| TYBOST 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 |
Testing Prior to Initiation of TYBOST
Prior to or when initiating TYBOST and during treatment with TYBOST, on a clinically appropriate schedule, assess estimated creatinine clearance because TYBOST decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Warnings and Precautions (5.1)]. When coadministering TYBOST with TDF, assess estimated creatinine clearance, urine glucose, and urine protein at baseline. In patients with chronic kidney disease, also assess serum phosphorus [see Warnings and Precautions (5.2)].
Renal Impairment
TYBOST coadministered with TDF is not recommended in patients who have an estimated creatinine clearance below 70 mL/min because dose adjustment of TDF is required below 50 mL/min and such dose adjustments have not been established for coadministration with TYBOST [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)].
Not Recommended During Pregnancy
TYBOST coadministered with darunavir is not recommended for use during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].
TYBOST coadministered with atazanavir is not recommended for use during pregnancy because of substantially lower exposures of cobicistat during the second and third trimesters [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)].
TYBOST coadministered with darunavir or atazanavir should not be initiated in pregnant individuals. An alternative regimen is recommended for individuals who become pregnant during therapy with TYBOST coadministered with darunavir or atazanavir.
