Important Safety Information Medication Guide and Prescribing Information
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Proven All-Day Efficacy1

Proven to provide effective ADHD symptom control1

DYANAVEL XR was shown to improve ADHD symptoms across 14 hours compared to placebo when measured with a standardized performance test, the PERMP* – a validated test that measures the ability to initiate a task, self-monitor/stay on task, and complete written seatwork.

The effect of DYANAVEL XR tablet on symptoms of ADHD in adults was measured by PERMP-T* scores1,2 (PERMP-T, Permanent Product Measure of Performance Total)

The primary efficacy endpoint—the mean PERMP-T score across all postdose time points at Visit 5 (last visit)—was met (DYANAVEL XR tablet: 302.8 [87.57†]; placebo: 279.6 [79.77†]; P=0.0043)

See how DYANAVEL XR tablet works fast and lasts.3

Improvement in Attention With DYANAVEL XR Tablet vs Placebo1

The response over time of DYANAVEL XR tablet was also measured by comparing PERMP-T scores between groups at all time points postdose

Improvement in Attention With DYANAVEL XR Tablet vs Placebo Efficacy Chart

Post hoc analysis by sequential time points:

PERMP-T scores at 30 minutes and 1, 2, 4, 8, and 13 hours postdose were statistically significantly higher with DYANAVEL XR tablet compared with placebo (P≤0.05)2

Study Design: This study employed a 5-week forced dose–titration phase. Eligible subjects aged 18 to 60 years were randomized to either oral, double-blind DYANAVEL XR tablet 5-mg starting dose or matching placebo once daily in the morning, beginning the day after the baseline visit. Subjects were titrated up (5-mg increments) each week. Safety and efficacy assessments were done weekly. After Visit 3, subjects received 20 mg for 14 (±3) days before Visit 5. Subjects who could not tolerate the study drug were discontinued. A PERMP placement test was done at screening or baseline. At Visit 5, efficacy assessments included the administration of serial PERMPs predose and 0.5, 1, 2, 4, 8, 10, 12, 13, and 14 hours postdose.1, 2

* The PERMP is a validated, time-sensitive, skill-adjusted test consisting of math problems to be completed at multiple time points (administration of serial PERMPs). It is a robust, objective measure of the ability to initiate a task, self-monitor/stay on task, and complete written seatwork. The PERMP does not test for mathematical ability or the ability to learn math because the difficulty of problems is adjusted to the existing math skill level of each participant.2

† Standard error.2

PERMP-T, Permanent Product Measure of Performance Total.

Did you know...?

DYANAVEL XR tablet has 8 different dosing options.

1 1/2 DYANAVEL XR Tablets Icon
Find answers to FAQs about DYANAVEL XR tablet

Save on your DYANAVEL XR prescription**

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Or text TRIS to TRIS4U (874748) for a Mobile Savings Card.†

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

‡Mobile Terms and Conditions: coupon.trisadhd.com/terms. Message data rates may apply.

References: 1. Cutler AJ, Pardo A, King TR, Rafla E, Duhoux S, Kando JC. Poster presented at: The American Professional Society of ADHD and Related Disorders; January 15-17, 2021; virtual conference. 2. Data on file. Tris Pharma, Inc; 2020. 3. Pardo A, Kando JC, King TR, Rafla E, Herman BK. CNS Spectr. 2020;25(6):774-781.

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 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.

See Additional Important Safety Information.

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 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:

  • 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. Since increases in blood pressure and heart rate may occur, the doctor should regularly check these during treatment. 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.
  • 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.
  • 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. Tell your doctor if you or your child become pregnant during treatment with any of these medicines.
  • if you or your child is breastfeeding or plan to breastfeed. DYANAVEL XR, Quillivant XR, and QuilliChew ER pass into breast milk. You or your child should not breastfeed while you are taking any of these medicines.

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 negative 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 and Dependence.

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