HTB

Once-daily option for paediatric use of darunavir/ritonavir

On 1 February 2013, the FDA approved revisions to the darunavir (Prezista) tablet and oral suspension label to include paediatric use.

This included once daily dosing in treatment-naïve subjects 3 to less than 18 years of age and once-daily dosing in treatment-experienced subjects 3 to less than 18 years of age with no darunavir resistance associated substitutions.

Weight-based dosing tables are included by age, weight and treatment experience.

For full details please see the full label and/or online infromation from the FDA list serve.

Source: FDA list serve. Prezista (darunavir) tablet and oral suspension: pediatric dosing. (1 February 2013).

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm337778.htm

Links to other websites are current at date of posting but not maintained.