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FDA Approve U.S. Pediatric Dose for Raltegravir

January/February 2012

On 21 December 2011, the FDA approved dosing recommendations for raltegravir (Isentress) for paediatric patients ages 2 to 18 years and weighing at least 10 kg.

In addition a 100 mg scored chewable tablet and 25 mg chewable tablet was approved for use in paediatric patients.

Safety, efficacy and formulation data were from the IMPAACT P1066 Phase I/II study in 126 treatment experienced children (age 2 to 18 years) who received either the 400 mg film-coated tablet formulation (6 to 18 years of age) or the chewable tablet formulation (2 to less than 12 years of age). Raltegravir was administered with an optimised background regimen.

The Dosage and Administration section includes the following dosing recommendations and dosing recommendations for pediatrics. Main changes to the product label are also included below.

General Dosing Recommendation

Paediatric Dosing

Dosing is recommended based on age and weight:

Warnings and Precautions

Raltegravir chewable tablets contain phenylalanine, a component of aspartame. Each 25 mg raltegravir chewable tablet contains approximately 0.05 mg phenylalanine. Each 100 mg raltegravir chewable tablet contains approximately 0.10 mg phenylalanine. Phenylalanine can be harmful to patients with phenylketonuria.

Adverse Reactions

In the IMPAACT P1066, 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.

The following information was added to Section 12.3 Pharmacokinetics:

Clinical Studies

The median age of the 96 study participants in IMPAACT P106 receiving the recommended raltegravir dose was 13 (range 2 to 18) years, 51% female, 34% Caucasian, and 59% Black. At baseline, mean plasma HIV-1 RNA was 4.3 log10 copies/mL, median CD4 cell count was 481 cells/mm3 (range: 0-2361) and median CD4% was 23.3% (range: 0-44). Overall, 8% had baseline plasma HIV-1 RNA >100,000 copies/mL and 59% had a CDC HIV clinical classification of category B or C. Most subjects had previously used at least one NNRTI (78%) or one PI (83%).

Ninety-three (97%) subjects completed 24 weeks of treatment (3 discontinued due to non-compliance). At Week 24, 54% achieved HIV RNA <50 copies/mL; 72% achieved HIV RNA <400 copies/mL or =1 log10 HIV RNA drop from baseline. The mean CD4 count (percent) increase from baseline to Week 24 was 119 cells/mm3 (3.8%).

Source: FDA HIV/AIDS Update (21 December 2011).

For full details please refer to the updated prescribing information:

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