Raltegravir

Adult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients. Pediatric Patients: ISENTRESS is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 2 kg. ISENTRESS HD is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients weighing at least 40 kg. Adult Patients: ISENTRESS ® and ISENTRESS ® HD are indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adult patients.

Raltegravir is an HIV-1 antiviral drug.

ISENTRESS and ISENTRESS HD can be administered with or without food. Do not substitute ISENTRESS chewable tablets or ISENTRESS for oral suspension for the ISENTRESS 400 mg or 600 mg film-coated tablet. See specific dosing guidance for chewable tablets and the formulation for oral suspension. Adults Treatment-naïve patients or patients who are virologically suppressed on an initial regimen of ISENTRESS 400 mg twice daily: 1200 mg (2 × 600 mg) film-coated tablet orally, once daily or 400 mg film-coated tablet orally, twice daily. Treatment-experienced patients: 400 mg film-coated tablet orally, twice daily. During coadministration with rifampin in adults, 800 mg (2 × 400 mg) twice daily.

None None.

Severe, potentially life-threatening and fatal skin reactions have been reported. This includes cases of Stevens-Johnson syndrome, hypersensitivity reaction and toxic epidermal necrolysis. Immediately discontinue treatment with ISENTRESS or ISENTRESS HD and other suspect agents if severe hypersensitivity, severe rash, or rash with systemic symptoms or liver aminotransferase elevations develops and monitor clinical status, including liver aminotransferases closely. Monitor for Immune Reconstitution Syndrome. Inform patients with phenylketonuria that the 100 mg and 25 mg chewable tablets contain phenylalanine.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The most common adverse reactions of moderate to severe intensity (≥2%) are insomnia, headache, dizziness, nausea and fatigue. Creatine kinase elevations were observed in subjects who received ISENTRESS or ISENTRESS HD. 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 and patients with a history of rhabdomyolysis, myopathy or increased serum creatine kinase.

Coadministration of ISENTRESS or ISENTRESS HD and other drugs may alter the plasma concentration of raltegravir. The potential for drug-drug interactions must be considered prior to and during therapy. Coadministration of ISENTRESS or ISENTRESS HD with drugs that are strong inducers of UGT1A1, such as rifampin, may result in reduced plasma concentrations of raltegravir.

Store at 20-25°C (68-77°F), excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature. 400 mg Film-coated Tablets, 600 mg Film-coated Tablets and Chewable Tablets Store in the original package with the bottle tightly closed. Keep the desiccant in the bottle to protect from moisture. For Oral Suspension Store in the original container.