NOW APPROVED

Available Summer 2021

Introducing AZSTARYS, the first and only treatment with a dexmethylphenidate-based prodrug for ADHD in patients 6 years and older

ADHD, attention deficit hyperactivity disorder.

AZSTARYS is not commercially available. Its controlled substance schedule is pending US Drug Enforcement Administration action.

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What is AZSTARYS?

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

AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep AZSTARYS in a safe place to prevent misuse and abuse. Selling or giving away AZSTARYS may harm others and is against the law.

Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Who should not take AZSTARYS?

Do not take AZSTARYS if you or your child are:

  • allergic to serdexmethylphenidate, methylphenidate, or any of the ingredients in AZSTARYS.
  • taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI).

Serious problems can occur while taking AZSTARYS. Tell your healthcare provider:

  • if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. Sudden death has occurred in people with heart problems or defects taking stimulant medicines. Sudden death, stroke and heart attack have happened in adults taking stimulant medicines. Your doctor should check you or your child carefully for heart problems before starting AZSTARYS. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. Call your healthcare provider right away or go to the nearest hospital emergency room if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking AZSTARYS.
  • if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. New or worse behavior and thought problems or new or worse bipolar illness may occur. New psychotic symptoms (such as seeing or hearing things that are not real, believing things that are not true, being suspicious) or new manic symptoms may occur. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment.
  • if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Priapism has occurred with methylphenidate (AZSTARYS). Because priapism can cause long-lasting damage, it should be checked by a healthcare professional right away.
  • if you or your child have circulation problems in fingers and toes (called peripheral vasculopathy, including Raynaud’s phenomenon). Fingers or toes may feel numb, cool, painful, sensitive to temperature, and/or change color from pale, to blue, to red. Call your healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking AZSTARYS.
  • if your child is having slowing of growth (height and weight). Your child should have his or her height and weight checked often while taking AZSTARYS.
  • if you or your child are pregnant or plan to become pregnant. It is not known if AZSTARYS may harm your unborn baby.
  • if you or your child are breastfeeding or plan to breastfeed. AZSTARYS passes into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take AZSTARYS.

What are possible side effects of AZSTARYS?

The most common side effects of AZSTARYS include:

  • decreased appetite
  • nausea
  • indigestion
  • weight loss
  • dizziness
  • mood swings
  • increased blood pressure
  • trouble sleeping
  • vomiting
  • stomach pain
  • anxiety
  • irritability
  • increased heart rate

These are not all the possible side effects of AZSTARYS. Call your doctor for medical advice about side effects.

What is AZSTARYS?

AZSTARYS is a central nervous system (CNS) stimulant prescription medicine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Reference: AZSTARYS. Prescribing information. Corium Inc; 2021.

IMPORTANT SAFETY INFORMATION

AZSTARYS is a federally controlled substance (CII) and it can be abused or lead to dependence. Keep AZSTARYS in a safe place, preferably locked to prevent abuse. Selling or giving away AZSTARYS may harm others and is against the law.

For additional safety information, click here for Prescribing Information and Medication Guide and discuss with your doctor.

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