PREZISTA- darunavir tablet, film coated PREZISTA- darunavir suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Janssen Products LP

INN (International Name):

darunavir ethanolate

Composition:

darunavir 75 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). 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 PREZISTA 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 a

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 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 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 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 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 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 Keep PREZISTA out of reach of children.

Authorization status:

New Drug Application

Summary of Product characteristics

PREZISTA- DARUNAVIR TABLET, FILM COATED
PREZISTA- DARUNAVIR SUSPENSION
JANSSEN PRODUCTS LP
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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)
4/2022
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
Testing:
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