AZSTARYS® is available nationwide
Recommended starting dose once daily
39.2 mg/In a clinical study of patients with ADHD aged 6 to 12 years, most patients were optimized on higher doses2,a
were optimized to
26.1 mg/5.2 mg
were optimized to
39.2 mg/7.8 mg
were optimized to
52.3 mg/10.4 mg
aThe randomized, double-blind, placebo-controlled, parallel-group, analog classroom study included pediatric patients with
ADHD aged 6 to 12 years (mean, 9.6 years). During the open-label dose-optimization phase (3 weeks), 155 patients were started
on AZSTARYS 39.2 mg/7.8 mg once daily in the morning. The dose could be titrated weekly to 26.1 mg/5.2 mg, 39.2 mg/7.8 mg,
or 52.3 mg/10.4 mg (maximum dose) based on tolerability and best individual response in the opinion of the investigator.1,2
bThe percentage of patients optimized does not add to 100% because 5 patients dropped out of the dose-optimization phase
(4 due to AEs and 1 failed to meet randomization criteria). The percentages here are calculated based on a total population of 55 patients.1,2
SDX
IR d-MPH
AZSTARYS (SDX/ d-MPH) |
Combined molar dose over the day (d-MPH HCl) |
---|---|
26.1 mg/5.2 mg | 20 mg |
39.2 mg/7.8 mg | 30 mg |
52.3 mg/10.4 mg | 40 mg |
AE, adverse events; d-MPH, dexmethylphenidate; HCl, hydrochloride; IR, immediate-release; MPH, methylphenidate; PK, pharmacokinetic; SDX, serdexmethylphenidate.
References: 1. AZSTARYS. Prescribing information.
Corium LLC; 2021.
2. Data on file. Corium LLC.
AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
WARNING: ABUSE, MISUSE, AND ADDICTION
AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
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Prescribing Information,
including Boxed WARNING.
AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.
WARNING: ABUSE, MISUSE, AND ADDICTION
AZSTARYS has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including AZSTARYS, can result in overdose and death and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing AZSTARYS, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
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