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

Redefine how you control
ADHD in Adults

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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Select a profile

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.
CLOSE

Resources for HCPs

AZSTARYS® Brochure for Adults.

AZSTARYS Brochure (Adults)

Learn more about the benefits of
AZSTARYS for adult patients

DOWNLOAD
Uncontrolled adult ADHD symptoms quick reference.

Sean's Profile

A quick reference for your adult
patients with inadequate symptom control

DOWNLOAD
Newly-diagnosed adult ADHD quick reference.

Sarah's Profile

A quick reference for your
newly diagnosed adult patients

DOWNLOAD

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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, 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 5. 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