- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Approves Isentress (Raltegravir) for Oral Suspension in Pediatric HIV Patients
Product also available in tablet form (January 8)
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.