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January 29, 2014

FDA OKs Oral Isentress to Treat HIV in Children

The U.S. Food and Drug Administration (FDA) has approved a new oral suspension form of the integrase inhibitor Isentress (raltegravir) for pediatric use, HIVandHepatitis reports. The indication of this liquid form of the drug is for the treatment of HIV in children who are at least four weeks old and weigh between about 7 and 44 pounds (3 and 20 kilograms).

A single-use packet of the oral suspension of the drug includes 100 milligrams of Isentress suspended in 5 milliliters of water, for an ultimate concentration of 20 mg per mL. The liquid should be drawn into an oral syringe in order to measure the dose and administered within half an hour of mixing. Isentress is also available in chewable tablets for older children and for people who are unable to swallow the standard tablets of the drug.

“We are very pleased that Isentress can now be a part of a treatment regimen for HIV-1 infected infants and children as young as four weeks of age,” Hedy Teppler, executive director of clinical research at Merck Research Laboratories, said in a release.

According to Merck, this new formulation should be available by the summer.

To read the HIVandHepatitis report, click here.

To read the Merck release, click here.

Search: Isentress, raltegravir, HIV, pediatric, children, U.S. Food and Drug Administration, FDA, HIVandHepatitis, oral suspension, liquid dose, Hedy Teppler, Merck.


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