TYBOST- cobicistat tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)

Διαθέσιμο από:

Gilead Sciences, Inc.

INN (Διεθνής Όνομα):

COBICISTAT

Σύνθεση:

COBICISTAT 150 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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. - 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 u

Περίληψη προϊόντος:

TYBOST tablets, 150 mg, are orange, round, biconvex, film-coated, and debossed with "GSI" on one side and plain faced on the other side. Each bottle contains 30 tablets (NDC 61958-1401-1) and a silica gel desiccant, with a child-resistant closure. Store at 25 °C (77 °F); excursions permitted to 15–30 °C (59–86 °F) (see USP Controlled Room Temperature).

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

TYBOST- COBICISTAT TABLET, FILM COATED
GILEAD SCIENCES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TYBOST SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR TYBOST.
TYBOST (COBICISTAT) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2012
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)
DOSAGE AND ADMINISTRATION
TYBOST must be coadministered with atazanavir or darunavir at the same
time, with food, and in
combination with other HIV-1 antiretroviral agents. (2.1, 2.2)
Recommended dosage in adults: (2.1)
TYBOST DOSAGE
COADMINISTERED AGENT DOSAGE
ADULT 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: TYBOST 150 mg orally once
daily. For dosage
recommendations of the coadministered protease inhibitor atazanavir or
darunavir, refer to Ta