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 * Prescribing Information
 * Patient Site

 * d-MPH/SDX
   Prodrug Technology
 * Efficacy Throughout
   the Day
 * Once-Daily
   Dosing
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A CONSISTENT DAY CAN MAKE
ALL THE
DIFFERENCE


A CONSISTENT DAY
CAN MAKE ALL THE
DIFFERENCE

AZSTARYS is the first and only d-MPH with novel SDX prodrug and IR activity for
symptom coverage throughout your patient’s day1-3


NOVEL SDX PRODRUG FOR CONTINUOUS
CONVERSION TO D-MPH1-4



Discover this unique
molecular advancement


RAPID ONSET WITH EXTENDED
EFFICACY AND A GRADUAL OFFSET1



IMPROVE ADHD SYMPTOMS
THROUGHOUT THE DAY


CONVENIENT ONCE-DAILY
DOSING
AND FLEXIBLE
ADMINISTRATION OPTIONS1



See how AZSTARYS fits
your
patients’ needs


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AZSTARYS

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HELP PATIENTS ACCESS COPAY
SAVINGS AND SUPPORT

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d-MPH, dexmethylphenidate; IR, immediate-
release; SDX, serdexmethylphenidate.

References: 1. AZSTARYS. Prescribing information.
Corium Inc; 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


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 AND DEPENDENCE

 * CNS stimulants, including
   AZSTARYS, other methylphenidate-
   containing products, and
   amphetamines, have a high
   potential
   for abuse and
   dependence. Assess the risk of
   abuse prior to prescribing, and
   monitor for signs of abuse and
   dependence
   while on therapy

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
   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
   association with CNS stimulant
   treatment at recommended doses in
   pediatric patients with
   structural
   cardiac abnormalities or other
   serious heart problems. In adults,
   sudden death, stroke, and myocardial
   infarction have
   been reported at
   recommended doses. Avoid use in
   patients with known structural
   cardiac abnormalities, cardiomyopathy,
   serious heart arrhythmias, coronary artery disease, and other serious heart
   problems.
 * CNS stimulants cause an increase in
   blood pressure and heart rate. Monitor
   all patients for hypertension and
   tachycardia.
 * Exacerbation of Pre-existing
   Psychosis: 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: May induce a mixed/manic
   episode in patients with bipolar
   disorder. Prior to initiating 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: At
   recommended doses, may cause
   psychotic or manic symptoms (e.g.,
   hallucinations, delusional thinking, or
   mania) in patients without a history of
   psychotic illness or mania. Discontinue
   if symptoms occur.
 * Cases of painful and prolonged penile
   erections and priapism have been
   reported with methylphenidate
   products. Immediate
   medical
   attention should be sought if signs or
   symptoms of prolonged penile
   erections or priapism are observed.
 * CNS stimulants, including AZSTARYS,
   are associated with peripheral
   vasculopathy, including Raynaud’s
   phenomenon. Signs and
   symptoms
   are usually intermittent and mild; very
   rare sequelae include digital ulceration
   and/or soft tissue breakdown.
   Carefully
   observe patients during
   treatment for digital changes. Further
   evaluation may be required, including
   referral.
 * CNS stimulants have been associated
   with weight loss and slowing of
   growth rate in pediatric patients.
   Monitor height and weight
   at
   appropriate intervals in pediatric
   patients. Treatment may need to be
   interrupted in children not growing or
   gaining weight as
   expected.

ADVERSE REACTIONS

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

DRUG INTERACTIONS

 * Adjust dosage of antihypertensive
   drug as needed. Monitor blood
   pressure.
 * Avoid use of AZSTARYS on the day of
   surgery if halogenated anesthetics
   will be used.

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© 2021 Corium Inc. All Rights Reserved.

COM-AZS-000788 06/21

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 AND DEPENDENCE

 * CNS stimulants, including AZSTARYS, other methylphenidate-containing
   products, and amphetamines, have a high potential for abuse and dependence.
   Assess the risk of abuse prior to prescribing, and monitor for signs of abuse
   and dependence while on therapy