DARUNAVIR- darunavir tablet, film coated

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

DARUNAVIR (UNII: YO603Y8113) (DARUNAVIR - UNII:YO603Y8113)

Disponible depuis:

Camber Pharmaceuticals, Inc.

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Darunavir tablets, co-administered with ritonavir (darunavir tablets/ritonavir), in combination with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection in adult and pediatric patients 3 years of age and older  [see  Use in Specific Populations (8.4) and  Clinical Studies (14)] . Co-administration of darunavir tablets/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Examples of these drugs and othercontraindicated drugs (which may lead to reduced efficacy of darunavir) are listed below [see Drug Interactions (7.3)] . Due to the need for co-administration of darunavir tablets with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications.   • Alpha 1-adrenoreceptor antagonist: alfuzosin 

Descriptif du produit:

Darunavir 400 mg tablets are supplied as orange, oval shaped, bevel edged, biconvex, film-coated tablets de-bossed with “H” on one side and “189” on the other side. They are supplied as follows: Bottles of 60                                                                                     NDC 31722-567-60 Darunavir 600 mg tablets are available as orange, oval shaped, biconvex, film-coated tablets de-bossed with “J” on one side and “7” on the other side. They are supplied as follows: Bottles of 60                                                                                    NDC 31722-568-60 Storage   Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep darunavir tablets out of reach of children.

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

DARUNAVIR - DARUNAVIR TABLET, FILM COATED
CAMBER PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DARUNAVIR TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR DARUNAVIR
TABLETS.
DARUNAVIR TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications (4) 4/2022
INDICATIONS AND USAGE
Darunavir tablets are a human immunodeficiency virus (HIV-1) protease
inhibitor indicated for the
treatment of HIV-1 infection in adult and pediatric patients 3 years
of age and older. Darunavir tablets
must be co-administered with ritonavir (darunavir tablets/ritonavir)
and with other antiretroviral agents. (1)
(1)
DOSAGE AND ADMINISTRATION
• Testing:
o In treatment-experienced patients, treatment history genotypic
and/or phenotypic testing is
recommended prior to initiation of therapy with darunavir
tablets/ritonavir to assess drug susceptibility of
the HIV-1 virus ( 2.1, 12.4)
o Monitor serum liver chemistry tests before and during therapy with
darunavir tablets/ritonavir. ( 2.1,
2.2, 5.2)
• Treatment-naïve adult patients and treatment-experienced adult
patients with no darunavir resistance
associated substitutions: 800 mg (two 400 mg tablets) taken with
ritonavir 100 mg once daily and with
food. ( 2.3)
• Treatment-experienced adult patients with at least one darunavir
resistance associated substitution: 600
mg (one 600 mg tablet) taken with ritonavir 100 mg twice daily and
with food. ( 2.3)
• Pregnant patients: 600 mg (one 600 mg tablet) taken with ritonavir
100 mg twice daily and with food. (
2.4)
• Pediatric patients (3 to less than 18 years of age and weighing at
least 10 kg): dosage of darunavir
tablets and ritonavir is based on body weight and should not exceed
the adult dose. Darunavir tablets
should be taken with ritonavir and with food. ( 2.5)
• Darunavir tablets/ritonavir is not recommended for use in patients
with severe hepatic impairment. ( 2.6)
DOSAGE FORMS AND STRENGTHS
•