Indications and Usage
ISENTRESS is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adult patients.

This indication is based on analyses of plasma HIV-1 RNA levels through 96 weeks in 3 double-blind controlled studies of ISENTRESS. Two of these studies were conducted in clinically advanced, 3-class antiretroviral—nonnucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), and protease inhibitor (PI)—treatment-experienced adults and 1 was conducted in treatment-naïve 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 pediatric patients.

Dosage and Administration
For the treatment of patients with HIV-1 infection, the dosage of ISENTRESS is 400 mg administered orally, twice daily with or without food. During coadministration with rifampin, the recommended dosage of ISENTRESS is
800 mg twice daily with or without food.

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
Coadministration of ISENTRESS with drugs that are strong inducers of uridine diphosphate glucuronosyltransferase (UGT) 1A1 may result in reduced plasma concentrations of raltegravir.

Adverse Reactions
The most common adverse reactions of moderate to severe intensity^a (≥2%) that occurred at a higher rate than the comparator were insomnia in treatment-naïve patients and headache in treatment-experienced patients.

^aIntensities were defined as follows: Moderate (discomfort enough to cause interference with usual activity); or Severe (incapacitating with inability to work or do usual activity)

Grade 2–4 creatine kinase laboratory abnormalities were observed in subjects treated with ISENTRESS. Myopathy and rhabdomyolysis have been reported. Use with caution in patients at increased risk of myopathy or rhabdomyolysis, such as patients receiving concomitant medications known to cause these conditions.

Rash occurred more commonly in treatment-experienced subjects receiving regimens containing ISENTRESS + darunavir/ritonavir compared to subjects receiving ISENTRESS without darunavir/ritonavir or darunavir/ritonavir without ISENTRESS. However, rash that was considered drug related occurred at similar rates for all 3 groups. These rashes were mild to moderate in severity and did not limit therapy; there were no discontinuations due to rash.

Pregnancy/Breastfeeding
ISENTRESS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

To monitor maternal-fetal outcomes of pregnant patients exposed to ISENTRESS, an Antiretroviral Pregnancy Registry has been established. Physicians are encouraged to register patients by calling 1-800-258-4263.

Before prescribing ISENTRESS, please read the Prescribing Information and Patient Product Information.