DARUNAVIR tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DARUNAVIR HYDRATE (UNII: KPC4NRB25L) (DARUNAVIR - UNII:YO603Y8113)

Available from:

Teva Pharmaceuticals, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Darunavir tablets, co-administered with ritonavir (darunavir/ritonavir), in combination with other antiretroviral agents, are 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/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 other contraindicated 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 with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. - Alpha 1-adrenoreceptor antagonist: alfuzosin - Anti-gout: colchicine, in patients with renal and/or hepatic impairment -

Product summary:

Darunavir tablets, 600 mg are supplied as orange, oval-shaped, film-coated tablets debossed with “TV” on one side and “7736” on the other side of the tablet. Tablets are available in bottles of 60 (NDC 0480-7736-06). Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep darunavir tablets out of reach of children.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DARUNAVIR- DARUNAVIR TABLET, FILM COATED
TEVA PHARMACEUTICALS, INC.
----------
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/ritonavir) and with
other antiretroviral agents. (1)
DOSAGE AND ADMINISTRATION
Testing:
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)
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 (one 800 mg tablet) 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 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
Tablets: 600 mg (3)
CONTRAINDICATIONS
Co-administration of daru