Unique Technology | DYANAVEL XR (amphetamine) Tablet | Tris Pharma
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Continuous Medication Release1,2

Discover advanced ADHD drug delivery with
DYANAVEL XR (amphetamine)

  • Our formulation of amphetamine contains millions of drug-particle complexes1
  • The key to each particle is a special coating that protects amphetamine and releases it consistently over time1
  • This protective layer makes sure the release of your medication won’t be affected by food or differences in your metabolism
  • In a pharmacokinetics study, results were similar whether DYANAVEL® XR tablet was taken on an empty stomach or with food, and whether chewed or swallowed1,3

See how our technology works and learn more about the smooth consistent drug release that makes DYANAVEL XR different

Mean Plasma d- and l-Amphetamine Concentration-Time Profiles for DYANAVEL XR2,3

Mean Plasma d- and I-Amphetamine Concentration-Time Profiles Chart

Study Details: Following a single, 20-mg oral dose of DYANAVEL® XR (amphetamine) tablet given to 36 healthy adults in a 4-period, 4-treatment, 4-sequence crossover study, exposures (Cmax and AUC) for d- and l-amphetamine were similar to administration of an equal dose of DYANAVEL® XR oral suspension. The median time to peak plasma concentration (Tmax ) for d- and l-amphetamine was 5 hours after dosing. The relative bioavailability of DYANAVEL® XR tablet compared with an equal dose of DYANAVEL® XR oral suspension, for d- and l-amphetamine, were 105% and 106%, respectively. Exposures (Cmax and AUC) for d- and l-amphetamine for DYANAVEL® XR tablet swallowed whole were similar to those when the tablet was chewed and were similar under fed and fasting conditions.2,3

AUC, area under the curve; Cmax, peak concentration; Tmax, time to maximum concentration.

Will not disrupt your morning routine— DYANAVEL XR can be taken with or without food

DXRT ADHD savings support guaranteed availability

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

DYANAVEL Delivered Program

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Fill your prescription through DYANAVEL Delivered for guaranteed availability!

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
Info for current patients

Savings Program

Dyanavel XR ADHD Savings Card

Fill your prescription at your local pharmacy and save!

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

Get savings card

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

References: 1. 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. 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. Dyanavel XR [package insert]. Tris Pharma, Inc., Monmouth Junction, NJ.

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine) 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.

See Additional Important Safety Information.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Important Safety Information & Approved Use

DYANAVEL® XR (amphetamine) 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.

Your healthcare provider should check you or your child's risk for abuse, misuse, and addiction before starting treatment with DYANAVEL XR 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 should not be taken if you or your child are allergic to amphetamine or any of the ingredients in DYANAVEL XR 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 can cause serious side effects including:

  • Risks for people with serious heart disease: Sudden death has happened in people who have heart defects or other serious heart disease. Before starting DYANAVEL XR, tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.
    Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with DYANAVEL XR.
  • Increase in blood pressure and heart rate.
    Your healthcare provider should check your or your child’s blood pressure and heart rate regularly during treatment with DYANAVEL XR.
  • Mental (psychiatric) problems, including new or worse behavior and thought problems, new or worse bipolar illness, new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms.
    Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Call the doctor right away if there are any new or worsening mental symptoms during treatment.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
    Call the doctor right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with DYANAVEL XR.
  • 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 with DYANAVEL XR.
  • Serotonin Syndrome. This problem may happen when DYANAVEL XR is taken with certain other medicines and may be life-threatening. Stop taking DYANAVEL XR and call your healthcare provider or go to the nearest hospital emergency room if you get symptoms such as 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.
  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with DYANAVEL XR. Your healthcare provider may stop your child’s DYANAVEL XR treatment if they are not growing or gaining weight as expected.
  • It is not known if DYANAVEL XR will harm the unborn baby. There is a pregnancy registry for females who are exposed to DYANAVEL XR during pregnancy. The purpose of the registry is to collect information about the health of females exposed to DYANAVEL XR and their baby. If you or your child becomes pregnant during treatment with DYANAVEL XR, 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/.
  • DYANAVEL XR passes into breast milk. You or your child should not breastfeed during treatment with DYANAVEL XR. Tell your doctor if you are breastfeeding or plan to breastfeed.
  • The most 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

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.

To report SUSPECTED ADVERSE REACTIONS, contact Tris Pharma, Inc. at (732) 940-0358 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

APPROVED USE

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

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

Please see Full Prescribing Information, including Boxed Warning about Abuse, Misuse and Addiction and Medication Guide.

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