Important Safety Information Medication Guide and Prescribing Information
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Your days may not be consistent
but your medication should be

Discover 13 hours of ADHD symptom control1

About Adult ADHDGuaranteed Availability

DYANAVEL XR is a central nervous system stimulant prescription medicine used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). DYANAVEL XR is a tablet that can be swallowed whole or chewed.

It is not known if DYANAVEL XR is safe and effective in children under 6 years of age.

DYANAVEL XR is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR has a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep DYANAVEL XR in a safe place to prevent abuse and misuse. Never give your DYANAVEL XR to anyone else, because it may cause death or harm them. Selling or giving away DYANAVEL XR may harm others and is against the law.

Unique Technology: Consistent control

If you feel like your ADHD medication isn't lasting as long as you need it to, DYANAVEL XR (amphetamine) may be an option that's right for you!

Continuous Icon

Continuous

Smooth release of amphetamine through the day2,3

Medication Action
Predictable Icon

Proven

ADHD symptom control for 13 hours1

Study Results
Flexible Dosing Icon

Flexible dosing

Tablets can be swallowed or chewed4

Dosing Options

We want to make getting DYANAVEL XR as easy and inexpensive as possible! Learn about your options below!

DYANAVEL Delivered Program

Fill your prescription through DYANAVEL Delivered for guaranteed availability!†

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Free, fast delivery, full patient support, and the lowest available price:

$25 for commercially-insured patients with DYANAVEL coverage*

$100 for patients who choose to pay cash*

Info for new patients ▼
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Info for current patients

Savings Program

Fill your prescription at your local pharmacy and save!

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Eligible patients pay $25* per month with the DYANAVEL XR Savings Program

Get savings card

Enter your phone number or email address to receive a link to the DYANAVEL® XR (amphetamine) Patient Brochure.

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ADHD in adults isn’t just about work or school — it can cause symptoms throughout the day and into the evening, affecting different areas of your life5

If you need your ADHD medication to work consistently—through the day, every day—DYANAVEL XR may be able to help.

Download
this brochure to learn more.
Join the DYANAVEL XR Community!

†Perigon Pharmacy 360 works directly with Tris Pharma to ensure DYANAVEL XR tablets are always available.

*Co-pay offer is subject to eligibility. Terms and Conditions apply.

References: 1. Childress AC, Wigal SB, Brams MN, et al. Efficacy and safety of amphetamine extended-release oral suspension in children with attentiondeficit/hyperactivity disorder. J Child Adolesc Psycholpharmacol. 2018;28(5):306-313. 2. Pardo A, Kando JC, King TR, Rafla E, Herman BK. Single-dose pharmacokinetics of amphetamine extended-release tablets compared with amphetamine extended-release oral suspension. CNS Spectr. 2020;25(6):774-781. 3. Kando JC, King TR, Pardo A. A novel, modified release drug delivery technology containing amphetamine and methylphenidate ion-exchange complexes. Poster presented at: American Psychiatric Association Annual Meeting; May 1-3, 2021. 4. Dyanavel XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ. 5. Jain R. Addressing diagnosis and treatment gaps in adults with attentiondeficit/hyperactivity disorder. Prim Care Companion CNS Disord. 2017;19(5):17nr02153. 6. Kessler RC, Adler L, Barkley R, Biederman J, Conners CK, Demler O, Faraone SV, Greenhill LL, Howes MJ, Secnik K, Spencer T, Ustun TB, Walters EE, Zaslavsky AM. The prevalence and correlates of adult ADHD in the United States: results from the National Comorbidity Survey Replication. Am J Psychiatry. 2006 Apr;163(4):716-23.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCI), and QuilliChew ER® (methylphenidate HCI) are federally controlled substances (CII) because they can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR, Quillivant XR, and QuilliChew ER have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep these medicines in a safe place to prevent abuse and misuse. Selling or giving away these medicines may harm others and is against the law. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER and will monitor you or your child during treatment. Tell your physician if you, your child, or any family members have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

See Additional Important Safety Information.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine), Quillivant XR® (methylphenidate HCl), and QuilliChew ER® (methylphenidate HCl) are federally controlled substances (CII) because they can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR, Quillivant XR, and QuilliChew ER have a high chance for abuse and misuse and may lead to substance use problems, including addiction. Keep these medicines in a safe place to prevent abuse and misuse. Selling or giving away these medicines may harm others and is against the law.

Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with DYANAVEL XR, Quillivant XR, and QuilliChew ER and will monitor you or your child during treatment. Tell your physician 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 including the antibiotic linezolid and the intravenous medicine methylene blue.

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

  • if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. This is important because sudden death has occurred in children 6 to 17 years old with heart problems or defects, and sudden death, stroke, and heart attack have happened in adults. Your doctor should check you or your child carefully for heart problems before starting any of these medicines. Call the doctor right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting while taking any of these medicines.
  • Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment.
  • if you or your child have mental problems, or a family history of suicide, bipolar illness, or depression. This is important because new or worsening behavior and thought problems or bipolar illness may occur. New symptoms such as seeing or hearing things that are not real, believing things that are not true, being suspicious, or having new manic symptoms may occur. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • 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 the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking DYANAVEL XR, Quillivant XR, or QuilliChew ER.
  • 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 DYANAVEL XR, Quillivant XR, or QuilliChew ER.
  • New or worsening tics or worsening Tourette’s syndrome. Tell your healthcare provider if you or your child get any new or worsening tics or worsening Tourette’s syndrome during treatment.
  • There have been cases of increased eye pressure and acute angle closure glaucoma, an emergency that results from a rapid increase in your eye pressure with Quillivant XR and QuilliChew ER. Call your healthcare provider right away if you or your child develop changes in your vision or eye pain, swelling, or redness.
  • if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Priapism has occurred with methylphenidate (Quillivant XR and QuilliChew ER). Because priapism can cause long-lasting damage, it should be checked by a doctor right away.
  • if you or your child have symptoms of serotonin syndrome - agitation, hallucinations, coma, or other changes in mental status; fast heartbeat; sweating or fever; nausea, vomiting, diarrhea; high or low blood pressure; problems controlling movements or muscle twitching; muscle stiffness or tightness. Serotonin syndrome may occur when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop DYANAVEL XR and call your doctor or go to the nearest hospital emergency room.
  • if you or your child have phenylketonuria (PKU). QuilliChew ER contains phenylalanine as part of the artificial sweetener, aspartame. The artificial sweetener may be harmful to people with PKU or who are allergic to phenylalanine.
  • if you or your child are pregnant or plan to become pregnant. It is not known if DYANAVEL XR, Quillivant XR, or QuilliChew ER will harm your unborn baby. There is a pregnancy registry for females who are exposed to DYANAVEL XR, Quillivant XR, or QuilliChew ER during pregnancy. The purpose of the registry is to collect information about the health of females exposed to DYANAVEL XR, Quillivant XR, or QuilliChew ER and their baby. If you or your child becomes pregnant during treatment with DYANAVEL XR, Quillivant XR, or QuilliChew ER, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
  • You and your child should not breastfeed while you are taking DYANAVEL XR. You and your healthcare provider should decide if you will take Quillivant XR or QuilliChew ER or breastfeed.

Common side effects of amphetamine products include:

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

Common side effects of methylphenidate products inlude:

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

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

APPROVED USE

DYANAVEL XR, Quillivant XR, and QuilliChew ER 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.

See Medication Guide for DYANAVEL XR, Quillivant XR, and QuilliChew ER.

See Full Prescribing Information for DYANAVEL XR, Quillivant XR, and QuilliChew ER, including Boxed Warning about Abuse, Misuse and Addiction.

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