FDA approves raltegravir for children older than 4 weeks
On 20 December 2013, the FDA approved a new oral suspension formulation of raltegravir (Isentress) for use in paediatric patients aged 4 weeks and older, weighing at least 3 kg to less than 20 kg.
The indication is for use in combination with other antiretroviral agents for the treatment of HIV-1. Each single-use packet for oral suspension contains 100 mg of raltegravir which is suspended in 5 mL of water giving a final concentration of 20 mg/mL.
A new document as part of the patient labeling includes detailed information about dosing of both this suspension and the previous paediatric chewable formulation. Because the formulations are not bioequivalent, chewable tablets and the oral suspension are not interchangeable and have specific guidance.
Merck expects to have the raltegravir oral suspension commercially available by the third quarter of 2014.
The revised label for all formulations are now posted on the FDA website under the brand name Isentress.