Pretreatment Screening

Prior to initiating treatment with AZSTARYS, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)].

Assess the risk of abuse prior to prescribing, and monitor for signs of abuse and dependence while on therapy. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for AZSTARYS use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)].

2.2 Recommended Dosage

Pediatric Patients 6 to 12 years of age

• The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning.
• The dosage may be increased after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day, or decreased after one week to a dosage of 26.1 mg serdexmethylphenidate/5.2 mg dexmethylphenidate per day, depending on response and tolerability.
• Maximum recommended dosage is 52.3 mg serdexmethylphendiate/10.4 mg dexmethyphenidate once daily.

Adults and Pediatric Patients 13 to 17 years of age

• The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning.
• Increase the dosage after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day.
• Maximum recommended dosage is 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate once daily.

Pharmacological treatment of ADHD may be needed for extended periods. Periodically re- evaluate the long-term use of AZSTARYS, and adjust dosage as needed.

Administration Information

Administer AZSTARYS orally once daily in the morning with or without food [see Clinical Pharmacology (12.3)].

AZSTARYS capsules may be taken whole, or opened and the entire contents sprinkled into 50 mL of water or over 2 tablespoons of applesauce. Consume all the drug/food mixture immediately or within 10 minutes of mixing; do not store for future use [see Clinical Pharmacology (12.3)].

Switching from Other Methylphenidate Products

If switching from other methylphenidate products, discontinue that treatment, and titrate with AZSTARYS using the titration schedule described above.

Do not substitute AZSTARYS for other methylphenidate products on a milligram-per-milligram basis because these products have different pharmacokinetic profiles from AZSTARYS and may have different methylphenidate base composition [see Description (11), Clinical Pharmacology (12.3)].

Dose Reduction and Discontinuation

If paradoxical aggravation of symptoms or other adverse reactions occur; the dosage should be reduced, or, if necessary, the drug should be discontinued. AZSTARYS should be periodically discontinued to assess the pediatric patient’s condition. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued.