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

Available at pharmacies nationwide — help patients access a copay offer

A prodrug innovation
that redefines
how ADHD is controlled1,2

 

A prodrug innovation
that redefines how
ADHD is controlled1,2

AZSTARYS is the FIRST and ONLY
d‑MPH
with novel SDX prodrug
and IR activity1,2

AZSTARYS continuously converts controlled amounts
of d-MPH throughout the day1-4

PK study in adults: Mean plasma concentrations of d-MPH
measured throughout the day1,a

AZSTARYS® continuously converts controlled amounts of d-MPH throughout the day.

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

 Mean plasma concentrations continued to gradually decline through 72 hours post dose.1

Consider AZSTARYS for your adult patients

How would you address
these challenges?

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Current ER medication does not last long
enough to control ADHD symptoms

PATIENT WITH ADHD

Name: Sean

Age: 25 years

Sex: Male

Current treatment: MPH ER stimulant

TREATMENT HISTORY

  • Diagnosed with ADHD at age 10 years
  • Initially treated with AMP
  • Multiple switched medications to balance coverage and tolerability

ADULT PATIENT CHALLENGES

  • Distracted in the morning and runs late for appointments
  • Received customer complaints for lack of attention to detail during the late afternoon
  • Complained about appetite suppression on prior AMP therapy
  • Tolerates current MPH medication well but struggles with a lack of symptom control

Is a switch to AZSTARYS appropriate?

Recently diagnosed with inattentive subtype ADHD

PATIENT WITH ADHD

Name: Sarah

Age: 42 years

Sex: Female

Current treatment: None

FAMILY HISTORY

  • 12-year-old son with ADHD taking an AMP ER stimulant for the past 4 years
  • History of anxiety

ADULT PATIENT CHALLENGES

  • Worries she may lose her job
  • Lacks focus at work
  • Frequently misses deadlines
  • Forgets appointments
  • Wants effective control while considering history of anxiety

Is starting with AZSTARYS appropriate?

40% of adult patients on AZSTARYS
switched from another regimen5

40% of adult ADHD patients starting AZSTARYS® switched from another regimen. 40% of adult ADHD patients starting AZSTARYS® switched from another regimen.

Adult AZSTARYS patients by most recent previous treatment (N=2033)

Source: IQVIA XPD prescriber dynamics data 7/1/2021 through 4/8/2022.

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Switching from other
MPH products CLOSE

TOTAL d-MPH HCI PER DOSE1

Switching from other MPH products

  • If switching from other MPH products, discontinue that treatment and titrate with AZSTARYS
    (serdexmethylphenidate and dexmethylphenidate) using the titration schedule
  • The recommended starting dose for AZSTARYS is 39.2 mg/7.8 mg once daily
  • Do not substitute AZSTARYS for other MPH products on a milligram-per-milligram basis because these products have different PK profiles from AZSTARYS and may have a different MPH base composition

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

Switching Recommendations Chart. Switching Recommendations Chart.
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AZSTARYS

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ADHD, Attention Deficit Hyperactivity Disorder; AMP, amphetamine; d-MPH, dexmethylphenidate; ER, extended-release; HCl, hydrochloride; IR, Immediate-release;
MPH, methylphenidate; PK, pharmacokinetics; SDX, serdexmethylphenidate.

References: 1. AZSTARYS. Prescribing information. Corium LLC; 2021. 2. Mickle T, Guenther S, Chi G, inventors; KemPharm, Inc, assignee. Methylphenidate-prodrugs, processes of making and using the same. U.S. patent 10,584,113. March 10, 2020. 3. 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:10.1080/17425255.2019.1675636 4. 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 5. 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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