Azstarys

AZSTARYS is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

• Pediatric Patients 6 to 12 years
  : Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Dosage may be increased to 52.3 mg/10.4 mg daily or decreased to 26.1 mg/5.2 mg daily after one week. Maximum recommended dosage is 52.3 mg/10.4 mg once daily.
• Adults and Pediatric Patients 13 to 17 years:
  Recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. Increase the dosage after one week to 52.3 mg/10.4 mg once daily depending on response and tolerability.
• Administer with or without food.
• Swallow capsules whole or open and sprinkle onto applesauce or add to water.
• To avoid substitution errors and overdosage, do not substitute for other methylphenidate products on a milligram-per-milligram basis.

AZSTARYS capsules are available as:

• 26.1 mg/5.2 mg (serdexmethylphenidate/dexmethylphenidate) – blue cap/grey body, imprinted with "286" on cap and "KP415" on the body
• 39.2 mg/7.8 mg (serdexmethylphenidate/dexmethylphenidate) – dark blue cap/grey body, imprinted with "429" on cap and "KP415" on the body
• 52.3 mg/10.4 mg (serdexmethylphenidate/dexmethylphenidate) – orange cap/grey body, imprinted with "5612" on cap and "KP415" on the body

There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ADHD medications, including AZSTARYS, during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388.

There are no available data on AZSTARYS use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes; however, AZSTARYS contains dexmethylphenidate and serdexmethylphenidate, a prodrug of dexmethylphenidate. Dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate. Published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There may be risks to the fetus associated with the use of CNS stimulants use during pregnancy (

No evidence of developmental effects were found in an embryo-fetal development study with oral administration of serdexmethylphenidate to rabbits during organogenesis at doses up to approximately 49 times the MRHD of 52 mg/day serdexmethylphenidate given to adults based on plasma levels (

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

CNS stimulants, such as AZSTARYS, can cause vasoconstriction and thereby decrease placental perfusion. No fetal and/or neonatal adverse reactions have been reported with the use of therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.

In embryo-fetal development studies conducted in rats and rabbits, dexmethylphenidate hydrochloride was administered orally at doses of up to 20 and 100 mg/kg/day, respectively, during the period of organogenesis. No evidence of malformations was found in either the rat or rabbit study; however, delayed fetal skeletal ossification was observed at the highest dose level in rats. When dexmethylphenidate hydrochloride was administered to rats throughout pregnancy and lactation at doses of up to 20 mg/kg/day, post-weaning body weight gain was decreased in male offspring at the highest dose, but no other effects on postnatal development were observed. At the highest doses tested, plasma levels [area under the curves (AUCs)] of dexmethylphenidate in pregnant rats and rabbits were approximately 3 and 1 times, respectively, those in adults dosed with 40 mg/day dexmethylphenidate hydrochloride.

Racemic methylphenidate hydrochloride has been shown to cause malformations (increased incidence of fetal spina bifida) in rabbits when given in doses of 200 mg/kg/day throughout organogenesis.

No evidence of developmental effects were found in an embryo-fetal development study with oral administration of serdexmethylphenidate in rabbits during organogenesis at doses of up to 374 mg/kg/day. At the highest dose tested, the plasma level [area under the curve (AUC)] of serdexmethylphenidate in pregnant rabbits was approximately 49 times that in adults dosed with 52 mg/day serdexmethylphenidate.