The safety and effectiveness of AZSTARYS have been established in pediatric patients ages 6 to 17 years of age for the treatment of ADHD. Use of AZSTARYS in patients 6 to 12 years of age is supported by a randomized, double-blind, placebo-controlled, parallel group trial in 155 pediatric patients with ADHD and a 12-month open-label long term safety trial in 238 patients [see Adverse Reactions (6.1), Clinical Studies (14)]. Use of AZSTARYS in pediatric patients 13 to 17 years of age is supported by additional pharmacokinetics analysis showing similar plasma concentration-time profiles of dexmethylphenidate in adolescents and adults after administration of the same dose of AZSTARYS [see Clinical Studies (14)]. The long-term efficacy of methylphenidate in pediatric patients has not been established.

The safety and effectiveness of AZSTARYS in pediatric patients less than 6 years have not been established.

Long Term Suppression of Growth

Growth should be monitored during treatment with stimulants, including AZSTARYS. Pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].

Juvenile Animal Toxicity Data

Rats treated with racemic methylphenidate early in the postnatal period through sexual maturation demonstrated a decrease in spontaneous locomotor activity in adulthood. A deficit in acquisition of a specific learning task was observed in females only. The doses at which these findings were observed are at least 3 times the MRHD of 40 mg/day dexmethylphenidate hydrochloride given to children on a mg/m2 basis.

In a study conducted in young rats, racemic methylphenidate hydrochloride was administered orally at doses of up to 100 mg/kg/day for 9 weeks, starting early in the postnatal period (postnatal Day 7) and continuing through sexual maturity (postnatal Week 10). When these animals were tested as adults (postnatal Weeks 13 to 14), decreased spontaneous locomotor activity was observed in males and females previously treated with 50 mg/kg/day racemic methylphenidate hydrochloride [approximately 3 times the maximum recommended human dose (MRHD) of 40 mg of dexmethylphenidate hydrochloride given to children on a mg/m2 basis] or greater, and a deficit in the acquisition of a specific learning task was seen in females exposed to the highest dose (6 times the MRHD of 40 mg of dexmethylphenidate hydrochloride given to children on a mg/m2 basis). The no effect level for juvenile neurobehavioral development in rats was 5 mg/kg/day racemic methylphenidate hydrochloride (less than the MRHD of 40 mg of dexmethylphenidate hydrochloride given to children on a mg/m2 basis). The clinical significance of the long-term behavioral effects observed in rats is unknown.

Serdexmethylphenidate was administered orally to juvenile rabbits at doses up to 280 mg/kg/day (approximately 50 times the MRHD of 52 mg/day serdexmethylphenidate given to children on a mg/m2 basis), respectively, for 6 months, starting at postnatal Day 28 and continuing through sexual maturity (postnatal Day 196). No adverse findings were observed at the highest dose of serdexmethylphenidate.