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AZSTARYS is designed to provide immediate and extended
d-MPH activity with a smooth and gradual offset1,3,4

AZSTARYS® is a 30% immediate release of IR d-MPH, followed by a 70% release of SDX prodrug.

AZSTARYS is Schedule II

  • Rapid AZSTARYS® mechanism of action image showing the rapid absorption of IR d-MPH. d-MPH is immediately
    released.1,4
  • Bioactivation AZSTARYS® mechanism of action image showing the bioactivation of SDX and the conversion to d-MPH. SDX travels to the lower GI tract,
    where it is bioactivated.1,5,6
    Using proprietary Ligand
    Activated Therapy® technology,
    SDX is converted to d-MPH.4,5
  • Continuous AZSTARYS® mechanism of action image showing the continuous conversion of SDX to d-MPH. The continuous conversion of
    d-MPH provides active drug
    throughout the day with a
    smooth and gradual offset.1,3,4

The Ligand Activated Therapy, or LAT, platform, is a registered trademark of KemPharm.
SDX is a complex of d-MPH and a serine amino acid ligand. In the lower GI tract, the serine ligand is cleaved off, uniformly producing active d-MPH. The serine moiety is inert and has no biologic activity.2,4-6

AZSTARYS continuously produces controlled
amounts of d-MPH throughout the day1,2,4,5

Unlike the dual peaks and troughs associated with d-MPH HCI ER,
AZSTARYS features a rapid rise followed by
a smooth and gradual decline
in d-MPH1

Mean plasma concentrations of
d-MPH measured throughout
the day1,a

Graph of mean plasma concentrations of d-MPH measured in healthy adults throughout the day.

Results are from a pharmacokinetics study of AZSTARYS in healthy adults under
fasted conditions.1,a The clinical relevance of these data has not been established.

aPlasma concentrations were measured following a single dose of AZSTARYS or d-MPH HCl ER capsule. Mean plasma concentrations continued to gradually decline through 72 hours post dose.1

Girl in a library Girl in a library

Sustained
symptom coverage
throughout the day

Safety studied in
pediatric patients

d-MPH, dexmethylphenidate; ER, extended-release; GI, gastrointestinal; HCl, hydrochloride; IR, immediate-release; 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. 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 4. 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 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. Gudin JA, Nalamachu SR. An overview of prodrug technology and its application for developing abuse-deterrent opioids. Postgrad Med. 2016;128(1):97-105. doi:10.1080/00325481.2016.1126186

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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