Isentress for Oral Suspension Receives New Indication
November 22, 2017 – The U.S. FDA has approved a new indication for Isentress® (raltegravir) for oral suspension, manufactured by Merck. The new indication is for the treatment, when used in combination with other antiretroviral agents, of full-term newborns up to four weeks of age who have been exposed to HIV-1 and weigh at least 2kg (4.5 lbs).
An HIV integrase strand transfer inhibitor, Isentress works by blocking an enzyme used by the virus to multiply. In a clinical study, newborns who were at high risk of contracting HIV-1 from their mothers tested HIV-negative after being treated with Isentress in combination with a standard antiretroviral (ART) regimen.
Recommended dosing for the new indication is based on weight and the child’s age. Treatment should begin within 24 to 48 hours of the child’s birth, with the mother having taken Isentress anywhere from two to 24 hours before delivery. Isentress is administered to the newborn as an oral suspension via syringe, and is prepared by mixing one packet of Isentress powder with 10mL of water. The suspension must be used within 30 minutes of preparation.
The FDA does not recommend Isentress for use in pre-term newborns, or in children who weigh less than 2kg. The drug was originally approved for use in the United States in 2007 to treat HIV-1 in adult patients, and in 2011 received FDA approval to treat children and adolescents from two to 18 years of age. Isentress is currently the only HIV integrase strand transfer inhibitor approved to treat newborns in the United States.
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