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Frequently Asked Questions

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Find answers to common questions about DYANAVEL® XR (amphetamine) tablet

DYANAVEL XR tablet is the first once-daily, extended-release amphetamine tablet for the treatment of ADHD. It is a central nervous system stimulant prescription medicine in the form of a tablet that can be swallowed whole or chewed, and is taken by mouth once every day in the morning, with or without food. DYANAVEL XR tablet may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. It is not known if DYANAVEL XR tablet is safe and effective in children under 6 years of age.

DYANAVEL XR may be used as part of a treatment program for ADHD that may include behavioral therapy or other interventions.

The XR stands for “eXtended Release.”

DYANAVEL XR tablet uses technology to allow for a continuous release of amphetamine throughout the day. This means that DYANAVEL XR only needs to be taken once each day in the morning, and the medicine is released throughout the day.

In a clinical study, DYANAVEL XR tablet was found effective at reducing the symptoms of ADHD in adults ages 18-60 years compared to a sugar pill.

The effect of DYANAVEL XR tablet on symptoms of ADHD was measured in a 5-week clinical study. The study included adults ages 18-60 with ADHD and evaluated the effectiveness of DYANAVEL XR tablet across time points. In the study, DYANAVEL XR tablet showed improvement in attention vs a sugar pill. Talk to your doctor about what these study results mean to you. In the study the most commonly reported treatment-emergent adverse events (TEAEs) (>5%) in theDYANAVEL XR Tablet group and greater than placebo were: decreased appetite, insomnia, dry mouth, irritability, headache, dizziness, initial insomnia, nausea, tachycardia, anxiety.

DYANAVEL XR is bubblegum-flavored.

Store DYANAVEL XR tablet in a safe place at 68°F to 77°F (20°C to 25°C). Keep DYANAVEL XR tablet and all medicines out of the reach of children.

DYANAVEL XR tablet is supplied as 5-mg scored, 10-mg unscored, 15-mg unscored, and 20-mg unscored chewable tablet options.

  • Take DYANAVEL XR tablet exactly as prescribed. Your healthcare provider may adjust the dose until it is right for you or your child
  • Take DYANAVEL XR tablet once each day in the morning
  • DYANAVEL XR tablet can be taken with or without food
  • DYANAVEL XR tablet can be swallowed whole or chewed
  • In case of overdose, call your poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room

DYANAVEL XR tablet is taken once each day in the morning

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.

  • 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.

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.

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

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

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