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:

Physicians Total Care, Inc.

INN (International Name):

darunavir ethanolate

Composition:

darunavir 400 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

PREZISTA® , co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV-1) infection. This indication is based on analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 controlled Phase 3 trials of 48 weeks duration in antiretroviral treatment-naïve and treatment-experienced patients and 2 controlled Phase 2 trials of 96 weeks duration in clinically advanced, treatment-experienced adult patients. PREZISTA, co-administered with ritonavir (PREZISTA/ritonavir), and with other antiretroviral agents, is indicated for the treatment of HIV-1 infection in pediatric patients 3 years of age and older [see Use in Specific Populations (8.4) ]. This indication is based on 24-week analyses of plasma HIV-1 RNA levels and CD4+ cell counts from 2 open-label Phase 2 trials in antiretroviral treatment-experienced pediatric patients (one trial in patients 6 to less than 18 years of age and one trial in patients 3 to less t

Product summary:

PREZISTA (darunavir) 400 mg tablets are supplied as light orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 400 mg of darunavir per tablet. Each tablet is debossed with "400MG" on one side and "TMC" on the other side. PREZISTA (darunavir) 600 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 600 mg of darunavir per tablet. Each tablet is debossed with "600MG" on one side and "TMC" on the other side. PREZISTA is packaged in bottles in the following configuration: 400 mg tablets—bottles of 60 (NDC 54868-5969-0) 600 mg tablets—bottles of 60 (NDC 54868-6369-0) Storage: PREZISTA Oral Suspension PREZISTA Tablets

Authorization status:

New Drug Application

Summary of Product characteristics

PREZISTA - DARUNAVIR TABLET, FILM COATED
PHYSICIANS TOTAL CARE, INC.
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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, FOR ORAL USE
PREZISTA (DARUNAVIR) TABLET, FILM COATED FOR ORAL USE
INITIAL U.S. APPROVAL – 2006
RECENT MAJOR CHANGES
• Indications and Usage
• Pediatric Patients (1.2)
12/2011
• Dosage and Administration
• Adult Patients (2.1)
12/2011
• Pediatric Patients (2.2)
12/2011
• Warnings and Precautions
• Severe Skin Reactions (5.3)
06/2012
• Immune Reconstitution Syndrome (5.8)
02/2012
• Pediatric Patients (5.11)
12/2011
INDICATIONS AND USAGE
PREZISTA is a human immunodeficiency virus (HIV-1) protease inhibitor
indicated for the treatment of HIV-1 infection in
adult patients. PREZISTA is also indicated for the treatment of HIV-1
infection in 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
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. (2.1)
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.
(2.1)
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 treatment-experienced
adult dose. Do not use once daily dosing in
pediatric patients. PREZISTA should be taken with ritonavir twice
daily and with food. (2.2)
PREZISTA/ritonavir is not recommended for use in patients with severe
hepatic impairment. (2.3)
DOSAGE FORMS AND STRENGTHS
100 mg/mL oral suspension (3)
75 mg tablets, 150 m