EVOTAZ- atazanavir and cobicistat tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ATAZANAVIR SULFATE (UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG)

Dostupno od:

E.R. Squibb & Sons, L.L.C.

INN (International ime):

ATAZANAVIR SULFATE

Sastav:

ATAZANAVIR 300 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

EVOTAZ® is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in the following populations [see Dosage and Administration (2.2, 2.3)] : Use of EVOTAZ in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see Clinical Pharmacology (12.4) ] . The concomitant use of EVOTAZ and the following drugs in Table 1, are contraindicated due to the potential for serious and/or life-threatening events or loss of therapeutic effect [see Warnings and Precautions (5.8, 5.9), Drug Interactions (7), and Clinical Pharmacology (12.3)]. EVOTAZ is contraindicated: Table 1: Drugs Contraindicated with EVOTAZ Alpha 1-adrenoreceptor antagonist alfuzosin Antianginal ranolazine Antiarrhythmics dronedarone Anticonvulsants carbamazepine, phenobarbital, phenytoin Antigout colchicine (when used in patients with hepatic and/or renal impairment) Antimycobacterials rifampin Antineoplastics irino

Proizvod sažetak:

EVOTAZ® tablets, 300 mg atazanavir and 150 mg cobicistat, are oval, biconvex, pink, film-coated, debossed with “3641” on one side and plain on the other side. Each bottle contains 30 tablets (NDC-0003-3641-11), a silica gel desiccant and is closed with a child-resistant closure. Store EVOTAZ tablets at 25°C (77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Status autorizacije:

New Drug Application

Svojstava lijeka

EVOTAZ- ATAZANAVIR AND COBICISTAT TABLET
E.R. SQUIBB & SONS, L.L.C.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVOTAZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVOTAZ.
EVOTAZ (ATAZANAVIR AND COBICISTAT) TABLET, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
INDICATIONS AND USAGE
EVOTAZ is a two-drug combination of atazanavir, a human
immunodeficiency virus (HIV-1) protease
inhibitor, and cobicistat, a CYP3A inhibitor indicated for use in
combination with other antiretroviral agents
for the treatment of HIV‑1 infection in adults and pediatric
patients weighing at least 35 kg. (1)
_Limitations of Use_
Use of EVOTAZ in treatment-experienced patients should be guided by
the number of baseline primary
protease inhibitor resistance substitutions. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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®
_Pretreatment testing: _Renal laboratory testing should be performed
in all patients prior to initiation of
EVOTAZ and continued during treatment with EVOTAZ. Hepatic testing
should be performed in
patients with underlying liver disease prior to initiation of EVOTAZ
and continued during treatment
with EVOTAZ. (2.1)
_Recommended dosage:_ One tablet once daily, taken orally with food in
adults and pediatric patients
weighing at least 35 kg. (2.2)
_Renal impairment:_ EVOTAZ is not recommended for use in
treatment-experienced patients with end-
stage renal disease managed with hemodialysis. (2.3, 8.6)
_Hepatic impairment:_ EVOTAZ is not recommended in patients with any
degree of hepatic impairment.
(2.4, 8.7)
Tablets: 300 mg of atazanavir and 150 mg of cobicistat. (3)
EVOTAZ is contraindicated in patients with previously demonstrated
hypersensitivity (e.g., Stevens-
Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any
of the components of this
product. (4)
Coadministration with certain drugs for which altered plasma
concentra