SYMTUZA- darunavir, cobicistat, emtricitabine, and tenofovir alafenamide tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

DARUNAVIR (UNII: YO603Y8113) (DARUNAVIR - UNII:YO603Y8113), COBICISTAT (UNII: LW2E03M5PG) (COBICISTAT - UNII:LW2E03M5PG), EMTRICITABINE (UNII: G70B4ETF4S) (EMTRICITABINE - UNII:G70B4ETF4S), TENOFOVIR ALAFENAMIDE (UNII: EL9943AG5J) (TENOFOVIR ANHYDROUS - UNII:W4HFE001U5)

Disponible depuis:

Janssen Products LP

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

SYMTUZA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 40 kg: - who have no prior antiretroviral treatment history or - who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6 months and have no known substitutions associated with resistance to darunavir or tenofovir. Darunavir and cobicistat are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. SYMTUZA should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Darunavir and cobicistat are both substrates of the cytochrome P450 3A (CYP3A) isoform. Co-administration of SYMTUZA with CYP3A inducers is expected to lower plasma concentrations of darunavir and cobicistat which may lead to loss of efficacy

Descriptif du produit:

SYMTUZA ® (darunavir, cobicistat, emtricitabine, and tenofovir alafenamide) tablets are supplied as yellow to yellowish-brown, capsule-shaped, film-coated tablets debossed with "8121" on one side and "JG" on the other side. SYMTUZA is packaged in bottles of 30 tablets (NDC 59676-800-30), with a silica gel desiccant and child-resistant closure. Storage

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

SYMTUZA- DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR
ALAFENAMIDE TABLET, FILM COATED
JANSSEN PRODUCTS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SYMTUZA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SYMTUZA.
SYMTUZA
(DARUNAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE)
TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 2018
WARNING: POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
SEVERE ACUTE EXACERBATIONS OF HEPATITIS B (HBV) HAVE BEEN REPORTED IN
PATIENTS WHO
ARE COINFECTED WITH HIV-1 AND HBV AND HAVE DISCONTINUED PRODUCTS
CONTAINING
EMTRICITABINE AND/OR TENOFOVIR DISOPROXIL FUMARATE (TDF), AND MAY
OCCUR WITH
DISCONTINUATION OF SYMTUZA. HEPATIC FUNCTION SHOULD BE MONITORED
CLOSELY IN THESE
PATIENTS. IF APPROPRIATE, ANTI-HEPATITIS B THERAPY MAY BE WARRANTED. (
5.1)
RECENT MAJOR CHANGES
Contraindications ( 4)
04/2022
INDICATIONS AND USAGE
SYMTUZA is a four-drug combination of darunavir (DRV), a human
immunodeficiency virus (HIV-1)
protease inhibitor, cobicistat (COBI), a CYP3A inhibitor, and
emtricitabine (FTC) and tenofovir alafenamide
(TAF), both HIV-1 nucleoside analog reverse transcriptase inhibitors,
and is indicated as a complete
regimen for the treatment of HIV-1 infection in adults and pediatric
patients weighing at least 40 kg:
who have no prior antiretroviral treatment history or
who are virologically suppressed (HIV-1 RNA less than 50 copies per
mL) on a stable antiretroviral
regimen for at least 6 months and have no known substitutions
associated with resistance to darunavir
or tenofovir. ( 1)
DOSAGE AND ADMINISTRATION
Testing: Prior to or when initiating SYMTUZA, test patients for HBV
infection.
Prior to or when initiating SYMTUZA, and during treatment with
SYMTUZA, on a clinically appropriate
schedule, assess serum creatinine, estimated creatinine clearance,
urine glucose, and urine protein in all
patients. In patients with chronic ki