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Indications and Usage
ISENTRESS in combination with other antiretroviral agents is indicated for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
This indication is based in analyses of plasma HIV-1 RNA levels up through 24 weeks in 2 controlled studies of ISENTRESS. These studies were conducted in clinically advanced, 3-class antiretroviral (NNRTI, NRTI, PI) treatment-experienced adults.
The use of other active agents with ISENTRESS is associated with a greater likelihood of treatment response.
The safety and efficacy of ISENTRESS have not been established in treatment-naïve adult patients or pediatric patients.
There are no study results demonstrating the effect of ISENTRESS on clinical progression of HIV-1 infection.
Warnings and Precautions
Immune Reconstitution Syndrome
During the initial phase of treatment, immune reconstitution syndrome can occur, which may necessitate further evaluation and treatment.
Drug Interactions
Caution should be used when coadministering ISENTRESS with strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 (eg, rifampin) due to reduced plasma concentrations of raltegravir.
Adverse Reactions
The most common adverse reactions (> 10%) of all intensities reported in either treatment group, regardless of causality, were diarrhea, nausea, headache, and pyrexia. The drug-related adverse reactions (> 2%) of moderate to severe intensity reported in subjects in either the ISENTRESS or placebo treatment group were diarrhea, nausea, and headache.
Creatine kinase elevations were observed in subjects who received ISENTRESS. Myopathy and rhabdomyolysis have been reported; however, the relationship of ISENTRESS to these events is not known. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions.
Before prescribing ISENTRESS, please read the Prescribing Information and Patient Product Information.
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