PREZISTA- darunavir tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DARUNAVIR ETHANOLATE (UNII: 33O78XF0BW) (DARUNAVIR - UNII:YO603Y8113)

Available from:

A-S Medication Solutions

INN (International Name):

DARUNAVIR ETHANOLATE

Composition:

DARUNAVIR 800 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PREZISTA® , co-administered with ritonavir (PREZISTA/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 PREZISTA/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). 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 PREZISTA with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. - Alpha 1-adrenoreceptor antagonist: alfuzosin - Antianginal: ranolazine - Antiarrhythmic: dronedarone - Anti-gout: colchicine, in patients

Product summary:

Product: 50090-1327 Product: 50090-1491 NDC: 50090-1491-0 60 TABLET, FILM COATED in a BOTTLE, PLASTIC

Authorization status:

New Drug Application

Summary of Product characteristics

PREZISTA- DARUNAVIR TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PREZISTA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PREZISTA.
PREZISTA (DARUNAVIR) ORAL SUSPENSION
PREZISTA (DARUNAVIR) TABLET, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications (4)
09/2018
INDICATIONS AND USAGE
PREZISTA is 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. PREZISTA must
be co-administered with ritonavir
(PREZISTA/ritonavir) and with other antiretroviral agents. (1)
DOSAGE AND ADMINISTRATION
T e sting:
In treatment-experienced patients, treatment history genotypic and/or
phenotypic testing is recommended prior to
initiation of therapy with PREZISTA/ritonavir to assess drug
susceptibility of the HIV-1 virus (2.1, 12.4)
Monitor serum liver chemistry tests before and during therapy with
PREZISTA/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 PREZISTA and ritonavir is
based on body weight and should not exceed the adult dose. PREZISTA
should be taken with ritonavir and with food.
(2.5)
PREZISTA/ritonavir is not recommended for use in patients with severe
hepatic impairment. (2.6)
DOSAGE FORMS AND STRENGTHS
Oral suspension: 100 mg per mL (3)
Tablets: 75 mg, 150 mg, 600 mg, and 800 mg (3)
CONTRAIND