PREZISTA, co-administered with 100 mg ritonavir (PREZISTA/rtv), and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus (HIV) infection in antiretroviral treatment-experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor.

This indication is based on Week 24 analyses of plasma HIV RNA levels and CD4+ cell counts from 2 controlled trials of PREZISTA/rtv in combination with other antiretroviral drugs. Both studies were conducted in clinically advanced, treatment-experienced (NRTIs, NNRTIs, and PIs) adult patients with evidence of HIV-1 replication despite ongoing antiretroviral therapy.

The following points should be considered when initiating therapy with PREZISTA/rtv:

• Treatment history and, when available, genotypic or phenotypic testing, should guide the use of PREZISTA/rtv (see MICROBIOLOGY).
• The use of other active agents with PREZISTA/rtv is associated with a greater likelihood of treatment response (see MICROBIOLOGY and INDICATIONS AND USAGE, Description of Clinical Studies).
• The risks and benefits of PREZISTA/rtv have not been established in treatment-naïve adult patients or pediatric patients.

Adults: The recommended oral dose of PREZISTA tablets is 600 mg (two 300 mg tablets or one 600 mg tablet) twice daily taken with ritonavir 100 mg twice daily and with food. The type of food does not affect exposure to darunavir.

Pediatric Patients: The safety and efficacy of PREZISTA in pediatric patients has not been established (see CLINICAL PHARMACOLOGY, Special Populations, Pediatric Patients).

Hepatic Impairment: No dose adjustment is required in patients with mild or moderate hepatic impairment. There are no data regarding the use of PREZISTA/rtv when co-administered to subjects with severe hepatic impairment; therefore, PREZISTA/rtv is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Adults, Special Populations, Hepatic Impairment and PRECAUTIONS, Patients with co-existing conditions, Hepatic Impairment).

Renal Impairment: No dose adjustment is required in patients with moderate renal impairment. There are no pharmacokinetic data available in HIV-1 infected patients with severe renal impairment or end stage renal disease (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Adults, Special Populations, Renal Impairment and PRECAUTIONS, Patients with co- existing conditions, Renal Impairment).

PREZISTA (darunavir) 300 mg tablets are supplied as orange, oval-shaped, film-coated tablets containing darunavir ethanolate equivalent to 300 mg of darunavir per tablet. Each tablet is debossed with "300" on one side and "TMC114" 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 "600" on one side and "" (curved triangle with a dot) on the other side.

PREZISTA tablets are packaged in bottles in the following configuration: 300 mg tablets-bottles of 120 (NDC 59676-560-01) 600 mg tablets-bottles of 60 (NDC 59676-562-01)

Storage

Store PREZISTA tablets at 25°C (77°F); with excursions permitted to 15°-30°C (59°-86°F).

Manufactured for Tibotec, Inc. by: JOLLC, Gurabo, Puerto Rico Distributed by: Tibotec Therapeutics, Division of Ortho Biotech Products, L.P., Raritan NJ 08869 Revised: February 2008. FDA Rev date: 3/7/2008

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