AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) 26.1/5.2 mg, 39.2/7.8 mg, 52.3/10.4 mg capsules.

AZSTARYS® is available nationwide

Convenient once-daily
dosing with
3 administration options1

Swallow whole icon

Swallow
whole

Small-sized capsules for
patients who prefer to
swallow them whole

or
Sprinkle into water icon

Sprinkle into
water

The capsule may be opened
and its contents sprinkled into
2 oz (50 mL) of watera

or
Sprinkle onto applesauce icon

Sprinkle onto
applesauce

The capsule may be opened
and its contents sprinkled over
2 tablespoons of applesaucea

Daily morning dose may be taken with or without food as part of the morning routine

aThe mixture should be consumed within 10 minutes and should not be stored for future use.

3 dosage strengths to meet
the individual
needs of
your patients1

Recommended
starting dose once daily
AZSTARYS™ 26.1/5.2 mg, 39.2/7.8 mg, 52.3/10.4 mg capsules are smaller than a dime AZSTARYS™ 26.1/5.2 mg, 39.2/7.8 mg, 52.3/10.4 mg capsules are smaller than a dime
26.1 mg/
5.2 mg

Recommended starting dose once daily

39.2 mg/
7.8 mg
52.3 mg/
10.4 mg
Graphic for comparison.
Not actual size.
  • Dosage may be titrated after 1 week
    • For patients aged 6-12, the dosage may be increased to 52.3/10.4 mg per day, or decreased to 26.1 mg/5.2 mg per day, depending on response and tolerability
    • For patients 13 and older, the dosage may be increased to 52.3/10.4 mg per day depending on response and tolerability
  • The maximum daily dose is 52.3 mg/10.4 mg

Dose optimization with AZSTARYS

In a clinical study of patients with ADHD aged 6 to 12 years, most patients were optimized on higher doses2,a

Most AZSTARYS® patients were ooptimized on higher doses. 3.2%b

were optimized to
26.1 mg/5.2 mg

Most AZSTARYS® patients were ooptimized on higher doses. 44.5%b

were optimized to
39.2 mg/7.8 mg

Most AZSTARYS® patients were ooptimized on higher doses. 49.0%b

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

Total d-MPH HCl per dose1

Switching from Other Methylphenidate Products

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

Total d-MPH HCl from the IR
d-MPH and SDX prodrug

Recommended starting
dose once daily
39.2 mg

SDX

7.8 mg

IR d-MPH

Total d-MPH HCl per dose
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
Image of boy putting books in his backpack Image of boy putting books in his backpack

Sustained
symptom coverage
throughout the day

CoriumCaresTM offers copay
savings and support for
patients
taking AZSTARYS

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.

INDICATION

AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

Important Safety
Information

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.

Contraindications

  • Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other product components. Bronchospasm, rash, and pruritus have occurred with AZSTARYS. Hypersensitivity reactions such as angioedema and anaphylactic reactions have occurred in patients treated with other methylphenidate products.
  • Concomitant treatment with a monoamine oxidase inhibitor (MAOI) or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis.

Warnings and Precautions

  • Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who were treated with CNS stimulants at the recommended ADHD dosage. Avoid AZSTARYS use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease.
  • CNS stimulants cause an increase in blood pressure and heart rate. Monitor all AZSTARYS-treated patients for hypertension and tachycardia.
  • Exacerbation of Pre-existing Psychosis: CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: CNS stimulants may induce a mixed mood/manic episode in patients with bipolar disorder. Prior to initiating AZSTARYS treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, or depression). New Psychotic or Manic Symptoms: CNS stimulants at the recommended dosage may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a history of psychotic illness or mania. Consider discontinuing AZSTARYS if symptoms occur.
  • Cases of painful and prolonged penile erections and priapism have been reported with methylphenidate use, in both adult and pediatric male patients. AZSTARYS-treated patients who develop abnormally sustained or frequent and painful erections should seek immediate medical attention.
  • CNS stimulants, including AZSTARYS, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Carefully observe patients during AZSTARYS treatment for digital changes. Further clinical evaluation may be appropriate for patients who develop signs or symptoms of peripheral vasculopathy.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor height and weight at appropriate intervals in AZSTARYS-treated pediatric patients. Treatment may need to be interrupted in pediatric patients not growing or gaining weight as expected.
  • Angle closure glaucoma associated with methylphenidate treatment has been reported. AZSTARYS-treated patients considered at risk for acute angle closure glaucoma should be evaluated by an ophthalmologist.
  • Elevation of intraocular pressure (IOP) associated with methylphenidate treatment has been reported. Use of AZSTARYS with patients who have open-angle glaucoma or abnormally increased IOP should only be considered if the benefit of treatment outweighs the risk. Closely monitor AZSTARYS-treated patients with a history of abnormally increased IOP or open angle glaucoma.
  • CNS stimulants, including methylphenidate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating AZSTARYS, assess family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor AZSTARYS-treated patients for the emergence or worsening of tics or Tourette’s syndrome, and discontinue treatment if clinically appropriate.

Adverse Reactions

  • Based on accumulated data from other methylphenidate products, the most common (>5% and twice the rate of placebo) adverse reactions are decreased appetite, decreased weight, nausea, abdominal pain, dyspepsia, vomiting, insomnia, anxiety, affect lability, irritability, dizziness, increased blood pressure, and tachycardia.

Drug Interactions

  • Adjust dosage of antihypertensive drug as needed. Monitor blood pressure.

Please click here for Full
Prescribing Information,
including Boxed WARNING.

INDICATION

AZSTARYS is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

IMPORTANT SAFETY INFORMATION

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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