Prezista

Prezista Indications/Uses

darunavir

Manufacturer:

Janssen

Distributor:

DCH Auriga - Healthcare
/
Four Star
Full Prescribing Info
Indications/Uses
Adult Patients: 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.
Pediatric 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 6 years of age and older [see Use in Children under Precautions].
This indication is based on 24-week analyses of plasma HIV-1 RNA levels and CD4+ cell counts from an open-label Phase 2 trial in antiretroviral treatment-experienced pediatric patients 6 to < 18 years of age.
In treatment-experienced adult and pediatric patients, the following points should be considered when initiating therapy with PREZISTA/ritonavir: Treatment history and, when available, genotypic or phenotypic testing should guide the use of PREZISTA/ritonavir [see Microbiology under Actions]; The use of other active agents with PREZISTA/ritonavir is associated with a greater likelihood of treatment response [see Microbiology under Actions and Pharmacology: Pharmacodynamics: Clinical Studies: Treatment-Experienced Adult Subjects under Actions].
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