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AZSTARYS® (serdexmethylphenidate and dexmethylphenidate) 26.1/5.2 mg, 39.2/7.8 mg, 52.3/10.4 mg capsules.
For patients aged 6 and up with ADHD

Available at pharmacies nationwide — help eligible patients access a copay offer

Watch the video to learn how AZSTARYS is a prodrug innovation for ADHD3

Immediate-release and Extended‑release

70% SDX prodrug | 30% IR d‑MPH
Capsule not actual size.

Each AZSTARYS capsule contains 70% SDX prodrug and 30% IR d‑MPH3

Rapid Absorption of IR d‑MPH

rapid absorption
For illustrative purposes only.

After the ingestion of AZSTARYS, IR d‑MPH is rapidly absorbed.3,4

Gradual Bioactivation of SDX

Gradual Bioactivation of SDX

SDX is gradually converted to d‑MPH through cleavage of the ligand, using the proprietary Ligand Activated Therapy® technology.3,5

All trademarks are property of their respective owners.

Continuous d‑MPH Throughout the Day

Mean plasma conentrations

Results are from a pharmacokinetics study of AZSTARYS in healthy adults under fasted conditions.3

The clinical relevance of these data has not been established.

aFollowing a single dose of AZSTARYS in healthy adults under fasted conditions.3

Click below to explore how AZSTARYS continuously delivers controlled amounts of d‑MPH throughout the day.3,6

SEE THE VIDEO
Doctor with patient
Actor portrayals.

Efficacy results in clinical trials

Safety studied in pediatric patients

ADHD=attention deficit hyperactivity disorder; d-MPH=dexmethylphenidate; IR=immediate-release; SDX=serdexmethylphenidate.

References: 1. Corium, Inc. Corium launches innovative ADHD treatment AZSTARYS™ (serdexmethylphenidate and dexmethylphenidate) in the U.S. for patients age 6 years and older [press release]. July 21, 2021. Accessed May 25, 2023. https://corium.com/pdf/Corium_AZSTARYS_Now_Available_Press_Release_7-21-21.pdf 2. Childress AC, Komolova M, Sallee FR. An update on the pharmacokinetic considerations in the treatment of ADHD with long-acting methylphenidate and amphetamine formulations. Expert Opin Drug Metab Toxicol. 2019;15(11):937-974. doi:10.108017425255.2019.1675636 3. AZSTARYS. Prescribing information. Corium, LLC; October 2023. 4. Braeckman R, Guenther S, Mickle TC, Barrett AC, Smith A, Oh C. Dose proportionality and steady-state pharmacokinetics of serdexmethylphenidate/dexmethylphenidate, a novel prodrug combination to treat attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2022;32(5):288-295. doi:10.1089/cap.2022.0015 5. Patrick KS, Radke JL, Raymond JR, et al. Drug regimen individualization for attention-deficit/hyperactivity disorder: guidance for methylphenidate and dexmethylphenidate formulations. Pharmacotherapy. 2019;39(6):677-688. doi:10.1002/phar.2190 6. Kollins SH, Braeckman R, Guenther S, et al. A randomized, controlled laboratory classroom study of serdexmethylphenidate and d-methylphenidate capsules in children with attention-deficit/hyperactivity disorder. J Child Adolesc Psychopharmacol. 2021;31(9):597-609. doi:10.1089/cap.2021.0077

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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