Isentress HD

Isentress HD Indications/Uses

raltegravir

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Full Prescribing Info
Indications/Uses
Adults: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.
This indication is based on analyses of plasma HIV-1 RNA levels in three double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults through 96 weeks and one was conducted in treatment-naïve adults through 240 weeks.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
Pediatrics: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in children and adolescents 2 years of age and older.
This indication is based on the evaluation of safety, tolerability, pharmacokinetic parameters and efficacy of ISENTRESS through at least 24-weeks in a multi-center, open-label, noncomparative study in HIV-1 infected, treatment-experienced children and adolescents 2 to 18 years of age (see Pharmacology: Pharmacodynamics: Clinical Studies under Actions).
The safety and efficacy of ISENTRESS 400 mg tablets have not been established in children less than 6 years of age. The safety and efficacy of ISENTRESS chewable tablets have not been established in children less than 2 years of age.
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