Tybost

Product manufactured by Gilead Sciences, Inc.

Application Nr Approved Date Route Status External Links
NDA203094 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Tybost Is A Cyp3a Inhibitor Indicated To Increase Systemic Exposure Of Atazanavir Or Darunavir (once Daily Dosing Regimen) 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 Weighing At Least 40 Kg Coadministered With Darunavir. ( 1.1 ) Limitations Of Use : Tybost Is Not Interchangeable With Ritonavir To Increase Systemic Exposure Of Darunavir 600 Mg Twice Daily, Fosamprenavir, Saquinavir, Or Tipranavir Due To Lack Of Exposure Data. The Use Of Tybost Is Not Recommended With Darunavir 600 Mg Twice Daily, Fosamprenavir, Saquinavir, Or Tipranavir. ( 1.2 , 5.4 ) Complex Or Unknown Mechanisms Of Drug Interactions Preclude Extrapolation Of Ritonavir Drug Interactions To Certain Tybost Interactions. Tybost And Ritonavir When Administered With Either Atazanavir Or Darunavir May Result In Different Drug Interactions When Used With Concomitant Medications. ( 1.2 , 5.3 , 7 , 12.3 ) 1.1 Indications Adult Patients: Tybost Is A Cyp3a Inhibitor Indicated To Increase Systemic Exposure Of Atazanavir Or Darunavir (once Daily Dosing Regimen) In Combination With Other Antiretroviral Agents In The Treatment Of Hiv-1 Infection In Adults [see Dosage And Administration (2.1) ]. Pediatric Patients: Tybost Is A Cyp3a Inhibitor Indicated To Increase Systemic Exposure Of Atazanavir Or Darunavir (once Daily Dosing Regimen) In Combination With Other Antiretroviral Agents In The Treatment Of Hiv-1 Infection In Pediatric Patients [see Dosage And Administration (2.2) ]: Weighing At Least 35 Kg Coadministered With Atazanavir Or Weighing At Least 40 Kg Coadministered With Darunavir. 1.2 Limitations Of Use Tybost Is Not Interchangeable With Ritonavir To Increase Systemic Exposure Of Darunavir 600 Mg Twice Daily, Fosamprenavir, Saquinavir, Or Tipranavir Due To Lack Of Exposure Data. The Use Of Tybost Is Not Recommended With Darunavir 600 Mg Twice Daily, Fosamprenavir, Saquinavir, Or Tipranavir [see Warnings And Precautions (5.4) ]. Complex Or Unknown Mechanisms Of Drug Interactions Preclude Extrapolation Of Ritonavir Drug Interactions To Certain Tybost Interactions. Tybost And Ritonavir When Administered With Either Atazanavir Or Darunavir May Result In Different Drug Interactions When Used With Concomitant Medications [see Warnings And Precautions (5.3) , Drug Interactions (7) , And Clinical Pharmacology (12.3) ].

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Cobicistat COBICISTAT ZINC85537014

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