FDA update label for paediatric efavirenz and capsule sprinkle formulation
On 2 May 2013, the FDA expanded the indication for Sustiva (efavirenz) to include pediatric patients at least three months old and weighing at least 3.5 kg.
For pediatric patients who cannot swallow capsules, the capsule contents can be administered with a small amount of food or infant formula using the capsule sprinkle method of administration.
The updated labeling includes a table for dosing along with the corresponding number of capsules or tablets and strength to administer.
For full details please see the updated Summary of Product Characteristics.
|Patient body weight||Efavirenz daily dose||Number of capsules (i) or tablets (ii) and strength to administer|
|3.5 kg to <5 kg||100 mg||2 x 50 mg capsule|
|5 kg to <7.5 kg||150 mg||3 x 50 mg capsules|
|7.5 kg to <15 kg||200 mg||1 x 200 mg capsule|
|15 kg to <20 kg||250 mg||1 x 200 mg PLUS 1 x 50 mg capsule|
|20 kg to <25 kg||300 mg||1 x 200 mg PLUS 2 x 50 mg capsule|
|25 kg to <32.5 kg||350 mg||1 x 200 mg PLUS 3 x 50 mg capsules|
|32.5 kg to <40 kg||400 mg||2 x 200 mg capsules|
|at least 40 kg||600 mg||1 x 600 mg tabletOR
3 x 200 mg capsules
(i) Capsules can be administered intact or as sprinkles
(ii) Tablets must not be crushed
BMS press statement. Bristol-Myers Squibb receives US FDA sNDA approval for use of Sustiva (efavirenz) in HIV-1 infected pediatric patients. (3 May 3 2013).