Indicated for:

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.

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.

The use of ISENTRESS is not recommended in preterm neonates.

Because the extent to which ISENTRESS may be dialyzable is unknown, dosing before a dialysis session should be avoided.

Severe, potentially life-threatening, and fatal skin reactions have been reported including Stevens-Johnson syndrome and toxic epidermal necrolysis.

Autoimmune disorders (such as Graves’ disease, polymyositis, and Guillain-Barré syndrome) have also been reported to occur in the setting of immune reconstitution; however, the time to onset is more variable, and can occur many months after initiation of treatment.

Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including ISENTRESS.

ISENTRESS Chewable Tablets contain phenylalanine, a component of aspartame. Phenylalanine can be harmful to patients with phenylketonuria.

Co-administration of ISENTRESS with drugs that inhibit UGT1A1 may increase plasma levels of raltegravir and coadministration of ISENTRESS with drugs that induce UGT1A1, such as rifampin, may reduce plasma levels of raltegravir.

Co-administration or staggered administration of ISENTRESS and ISENTRESS HD is not recommended with aluminum and/or magnesium-containing antacids.

Co-administration administration of ISENTRESS and ISENTRESS HD is not recommended with carbamazepine, phenobarbital, and phenytoin.

Co-administration of ISENTRESS HD is not recommended with calcium carbonate antacid.

Co-administration of ISENTRESS HD is not recommended with rifampin, tipranavir/ritonavir, and etravirine.

Available data from the APR show no difference in the rate of overall birth defects for raltegravir compared to the background rate for major birth defects of 2.7% in the U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). The rate of miscarriage is not reported in the APR.

Breastfeeding is not recommended while taking ISENTRESS. In addition, it is recommended that HIV-1-infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1.

GoToSource

• Use in preterm neonates. GoToSource 

• Herpes. GoToSource

Stevens-johnson syndrome and toxic epidermal necrolysis (severe skin reactions). GoToSource

Cerebellar ataxia (damage or loss of nerve cells in part of the brain that controls muscle coordination). GoToSource

Immune reconstitution syndrome (paradoxical worsening of preexisting infectious processes). GoToSource 

Increased trunk fat, limb fat, and overall fat and decreased bone mineral density. GoToSource 

Rhabdomyolysis (breakdown of muscle tissue). GoToSource 

Virological failure and tumors (non-Hodgkin’s lymphomas and hepatocarcinoma). GoToSource  

Dyslipidemia (elevated lipids). GoToSource 

Congenital heart valve disorders and sudden infant death syndrome. GoToSource

Lawsuits filed for congenital heart valve disorders and sudden infant death syndrome.