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

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, if needed
    • For patients aged 6 to 12 years, the dosage may be increased to 52.3 mg/10.4 mg or decreased to 26.1 mg/5.2 mg daily
    • For patients aged ≥13 years, the dosage may be increased to 52.3 mg/10.4 mg once daily
  • 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

dose pill 3.2%b

were optimized to
26.1 mg/5.2 mg

dose pill 44.5%b

were optimized to
39.2 mg/7.8 mg

dose pill 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 MPH products

  • If switching from other MPH products, discontinue that treatment and titrate with AZSTARYS 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
  • 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 different MPH 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 Inc; 2021. 2. Data on file. Corium, Inc.

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, or 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.

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 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