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APPROVED USE

Dyanavel XR (amphetamine), Quillivant XR (methylyphenidate hydrochloride), and QuilliChew ER(methylyphenidate hydrochloride) are central nervous system (CNS) stimulant prescription medicines used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years and older. These medicines may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

It is not known if Dyanavel XR, Quillivant XR, and QuilliChew ER are safe and effective in children under 6 years of age.

IMPORTANT SAFETY INFORMATION

Dyanavel XR, Quillivant XR, and QuilliChew ER are federally controlled substances (CII) because they can be abused or lead to dependence. Keep these medicines in a safe place to prevent misuse and abuse. Selling or giving away these medicines may harm others and is against the law. Tell your doctor if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Dyanavel XR, or Quillivant XR and QuilliChew ER, should not be taken if you or your child are allergic to amphetamine or methylphenidate hydrochloride, respectively, or any of the ingredients in these medicines, or are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.

Dyanavel XR, Quillivant XR, and QuilliChew ER can cause serious side effects. Tell the doctor:

Common side effects of amphetamine products include:

  • dry mouth
  • decreased appetite
  • weight loss
  • stomach pain
  • nausea
  • trouble sleeping
  • restlessness
  • extreme mood changes
  • dizziness
  • increased heart rate
  • dry mouth
  • decreased appetite
  • weight loss
  • stomach pain
  • nausea
  • trouble sleeping
  • restlessness
  • extreme mood changes
  • dizziness
  • increased heart rate

Common side effects of methylphenidate products include:

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

Talk to your doctor if you or your child have any side effects that bother you or do not go away.

Avoid drinking alcohol while taking Dyanavel XR, Quillivant XR, or QuilliChew ER.

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.

Please see Medication Guide and Full Prescribing Information for Dyanavel XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse and Dependence.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare professional. All decisions regarding patient care must be made with a healthcare professional, considering the unique characteristics of the patient.

This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our online privacy policy for more information. While Tris Pharma makes reasonable efforts to include accurate, up-to-date information on the site, Tris Pharma makes no warranties or representations as to its accuracy. Tris Pharma assumes no liability for any errors or omissions in the content of the site.

DYANAVEL is a registered trademark of Tris Pharma, Inc. Quillivant XR and QuilliChew ER are registered trademarks of NextWave Pharmaceuticals, Inc. © 2022 Tris Pharma, Inc. All rights reserved. DXR.1460.PR      10/22