TYBOST

AbsorptionIn a trial where participants were instructed to take coadministered TYBOST and darunavir with food, median cobicistat peak plasma concentrations were observed approximately 3.5 hours postdose. Steady-state cobicistat C max , AUC tau, and C tau (mean ± SD) values were 0.99 ± 0.3 mcg/mL (n=60), 7.6 ± 3.7 mcg∙hr/mL (n=59), and 0.03 ± 0.1 mcg/mL (n=59), respectively. Effect of Food on Oral Absorption A food-effect trial was not conducted for TYBOST. In clinical trials, TYBOST was coadmin...

14.1 Clinical Trial Results in Treatment-Naïve Adult Participants with HIV-1 –

Trial 114The activity of TYBOST as a CYP3A inhibitor to increase the systemic exposures of atazanavir or darunavir has been demonstrated in pharmacokinetic trials. In these trials, the exposure of atazanavir or darunavir coadministered with TYBOST 150 mg was consistent with those observed with ritonavir 100 mg [see Clinical Pharmacology (12.2) ] . For clinical efficacy of darunavir/ritonavir 800/100 mg once daily, refer to the prescribing information for darunavir. The safety and efficacy of TYBOST coadministered w...

The following adverse reaction is described in greater detail in another section of the labeling: New Onset or Worsening Renal Impairment When Used with Tenofovir Disoproxil Fumarate [see Warnings and Precautions (5.2) ]. The most common adverse drug reactions observed with TYBOST in combination with atazanavir (incidence greater than 5%, Grades 2−4) are jaundice and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or w...

The concomitant use of TYBOST with atazanavir or darunavir and the following drugs is contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect [see Drug Interactions (7.3) and Clinical Pharmacology (12.3) ] . Alpha 1-adrenoreceptor antagonist: alfuzosin Antianginal: ranolazine Antiarrhythmic: dronedarone Anticonvulsants: carbamazepine, phenobarb...

Assess creatinine clearance (CLcr) before initiating treatment. ( 5.1 ) When TYBOST is used in combination with a TDF-containing regimen, cases of acute renal failure and Fanconi syndrome have been reported. ( 5.2 ) Use with TDF: Assess urine glucose and urine protein at baseline and monitor CLcr, urine glucose, and urine protein. Monitor serum phosphorus in patients with or at risk for renal impairment. ( 5.2 ) TYBOST in combination with more than one antiretroviral that requires pharmacokineti...

7 DRUG INTERACTIONS TYBOST, in combination with atazanavir or darunavir, can alter the concentration of drugs metabolized by CYP3A or CYP2D6. Drugs that induce CYP3A can alter the concentrations of TYBOST, atazanavir and darunavir. Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 5.3 , 7 , 12.3 ) 7.1 Potential Effect of Cobicistat (Coadm...