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FDA Approves Oral Raltegravir for Children with HIV


The U.S. Food and Drug Administration (FDA) last month approved a new dosage form of the HIV integrase inhibitor raltegravir (Isentress). The new raltegravir oral suspension is indicated for pediatric patients age 4 weeks or older weighing 3-20 kg (about 7-44 lb).

Each single-use packet of the oral suspension contains 100 mg of raltegravir, which is to be suspended in 5 mL of water, giving a final concentration of 20 mg/mL. An oral syringe should be used to measure the correct dose, and the drug should be administered within 30 minutes after mixing.

Merck has indicated that the new oral formulation is expected to be commercially available by the third quarter of 2014. Raltegravir is also available in chewable tablets for older children and others who cannot swallow the regular film-coated tablets.

Detailed dosing information using the various raltegravir formulations is available online from the FDA.



R Klein, K Struble, and S Morin, FDA. New Isentress (raltegravir) dosage form: oral suspension. Consumer information

Merck. Merck Receives FDA Approval for ISENTRESS (raltegravir) for Pediatric Oral Suspension. Press release. January 8, 2013.