Label Changes for:
Isentress (raltegravir) scored, chewable tablets, film coated tablets
Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
WARNINGS AND PRECAUTIONS
- Isentress chewable tablets contain phenylalanine, a component of aspartame. Each 25 mg Isentress chewable tablet contains approximately 0.05 mg phenylalanine. Each 100 mg Isentress chewable tablet contains approximately 0.10 mg phenylalanine. Phenylalanine can be harmful to patients with phenylketonuria.
Clinical Trials Experience: Pediatrics
- Isentress has been studied in 126 antiretroviral treatment-experienced HIV-1 infected children and adolescents 2 through 18 years of age, in combination with other antiretroviral agents in IMPAACT P1066. Of the 126 patients, 96 received the recommended dose of Isentress. In these 96 children and adolescents, frequency, type and severity of drug related adverse reactions through Week 24 were comparable to those observed in adults.
- One patient experienced drug related clinical adverse reactions of Grade 3 psychomotor hyperactivity, abnormal behavior and insomnia; one patient experienced a Grade 2 serious drug related allergic rash.
- One patient experienced drug related laboratory abnormalities, Grade 4 AST and Grade 3 ALT, which were considered serious.
There are no data to guide co-administration of Isentress with rifampin in patients below 18 years of age
- All interaction studies were performed in adults
USE IN SPECIFIC POPULATIONS
- The safety, tolerability, pharmacokinetic profile, and efficacy of Isentress were evaluated in HIV-1 infected children and adolescents 2 to 18 years of age in an open-label, multicenter clinical trial, IMPAACT P1066. The safety profile was comparable to that observed in adults. See Dosage and Administration for dosing recommendations for children 2 years of age and older. Safety and effectiveness of Isentress in children under 2 years of age have not been established…
- The initial dose finding stage included intensive pharmacokinetic evaluation. Dose selection was based upon achieving similar raltegravir plasma exposure and trough concentration as seen in adults, and acceptable short term safety…