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FDA Approves Isentress (Raltegravir) for Oral Suspension in Pediatric HIV Patients
The FDA has approved Isentress (Merck) for oral suspension, a new pediatric formulation of the integrase inhibitor raltegravir. With this approval, Isentress is now indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency-1 (HIV-1) infection in patients 4 weeks of age and older.
The use of other active agents with Isentress is associated with a greater likelihood of a treatment response. The oral suspension may be used in patients as young as 4 weeks of age, weighing at least 3 kg to less than 20 kg. The safety and efficacy of Isentress have not been established in infants younger than 4 weeks of age.
Formulations of Isentress for specific populations now include oral suspension, chewable tablets, and film-coated tablets.
Isentress (raltegravir) works by inhibiting the insertion of HIV-1 DNA into human DNA by the integrase enzyme. Inhibiting integrase from performing this essential function limits the ability of the virus to replicate and infect new cells.
Source: Merck; January 8, 2013.