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Pediatric Dose Recommendations for Darunavir (Prezista) and Raltegravir (Isentress)

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The U.S. Food and Drug Administration (FDA) recently announced the approval of new dose recommendations and easy-to-use formulations of 2 antiretroviral drugs for children with HIV.

Darunavir (Prezista)

On December 16 the agency approved an oral suspension liquid formulation of darunavir, an HIV protease inhibitor produced by Tibotec/Janssen.

The darunavir product label was updated to provide dose recommendations for children 3 to 6 years of age, and for adult and pediatric patients older than 6 years who have difficulty swallowing darunavir tablets. Dosing for children is based on body weight; darunavir should be boosted with a low dose of ritonavir (Norvir), which is also available in a liquid formulation.

The Clinical Studies and Adverse Events sections were revised to reflect data from Study TMC114-C228, looking at treatment-experienced pediatric patients. The most common side effects were diarrhea (19%), vomiting (14%), and rash (10%); no serious drug-related laboratory abnormalities were reported. Children younger than 3 years should not use darunavir.

A full description of the label changes is available on the FDA website.

Raltegravir (Isentress)

On December 21 the FDA approved a raltegravir 100 mg scored (marked for dividing) chewable tablet and a 25 mg chewable tablet for use by children with HIV.

Merck's raltegravir -- the sole approved HIV integrase inhibitor -- is now approved for children aged 2 to 18 years and weighing at least 10 kg (about 22 lb). The maximum dose of the chewable tablets is 300 mg twice-daily.

Here too, the Clinical Trials and Adverse Events sections of the product label were updated to add information from the IMPAACT P1066 study of treatment-experienced pediatric patients. Raltegravir was well-tolerated and side effects in children were similar to those seen in adults.

Again, a full description of the label changes is on the FDA website.

12/27/11

Sources

R Klein and K Struble, U.S. Food and Drug Administration. Updated Information about Prezista (darunavir): Oral Suspension and Labeling Changes. HIV/AIDS Update. December 16, 2011.

R Klein and K Struble, U.S. Food and Drug Administration. Isentress (raltegravir): Pediatric Dosing Recommendations and 2 Chewable Tablet Formulations for Pediatric Dosing. HIV/AIDS Update. December 21, 2011.