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.

Table 1: Weight and dose table for paediatric use of efavirenz
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).

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