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:

REMEDYREPACK INC.

INN (International Name):

DARUNAVIR ETHANOLATE

Composition:

DARUNAVIR 600 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 in Table 6 . Due to the need for co-administration of PREZISTA with ritonavir, please refer to ritonavir prescribing information for a description of ritonavir contraindications. Co-administration of PREZISTA/ritonavir is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are

Product summary:

PREZISTA (darunavir) 100 mg per mL oral suspension is a white to off-white opaque liquid supplied in amber-colored multiple-dose bottles containing darunavir ethanolate equivalent to 100 mg of darunavir per mL packaged with a 6 mL oral dosing syringe with 0.2 mL gradations. PREZISTA (darunavir) 75 mg tablets are supplied as white, caplet-shaped, film-coated tablets containing darunavir ethanolate equivalent to 75 mg of darunavir per tablet. Each tablet is debossed with "75" on one side and "TMC" on the other side. PREZISTA (darunavir) 150 mg tablets are supplied as white, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 150 mg of darunavir per tablet. Each tablet is debossed with "150" 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 (darunavir) 800 mg tablets are supplied as dark red, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 800 mg of darunavir per tablet. Each tablet is debossed with "800" on one side and "T" on the other side. PREZISTA is packaged in bottles in the following configuration: Storage PREZISTA Oral Suspension PREZISTA Tablets

Authorization status:

New Drug Application

Summary of Product characteristics

PREZISTA- DARUNAVIR TABLET, FILM COATED
REMEDYREPACK 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
PREZISTA (DARUNAVIR) TABLET, FOR ORAL USE
INITIAL U.S. APPROVAL: 2006
RECENT MAJOR CHANGES
Contraindications ( 4)
06/2017
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)
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