Important Safety Information
Medication Guide and Prescribing Information
Tris Pharma DYANAVEL XR ADHD adults and childred

About ADHD and how to treat it

About ADHD

ADHD is a condition that can negatively impact a person’s attention and behavior and can interfere with daily activities at school, at work, at home, and with friends. People who have ADHD have higher levels of inattention, impulsivity, and/or hyperactivity than their peers.

ADHD is one of the most common brain-based disorders that affects about 1 in 10 school-aged children. For more than half of those who have ADHD as a child, symptoms continue into adulthood.

Some common symptoms of ADHD include trouble paying attention or focusing, impulsive behaviors, and being overly active. Symptoms may range from mild to severe. Children with ADHD may act out without thinking about the results, have learning challenges, make careless mistakes, forget or lose things, and squirm or fidget when sitting.

There is no scientifically proven cure for ADHD, and ADHD continues into adulthood in most cases. However, by developing strengths, structuring environments, and using the proper treatment plan—which may include parent/caregiver behavior training, school accommodations, and medication for treating ADHD—people with ADHD can manage their symptoms. Read about Tris Pharma treatments for ADHD, including Quillivant XR® (methylphenidate HCI), QuilliChew ER® (methylphenidate HCI), DYANAVEL® XR (amphetamine) liquid, and DYANAVEL® XR (amphetamine) tablet.

Research to date has shown that ADHD is a brain condition whose symptoms are also dependent on a number of factors, including family genetics. In fact, in 41% to 55% of families with at least one child with ADHD, at least one parent is also affected. Similarly, if a parent has ADHD, the child has up to a 57% chance of also having ADHD. If your child has been diagnosed with ADHD, you may want to discuss this with your own doctor to see if you may have ADHD.

Your child’s pediatrician may also suggest screening your other children. Siblings can even be a consideration when determining ADHD treatment. If an older sibling with ADHD has responded well to one kind of ADHD medication, pediatricians may often recommend the same medication for other children in the family with ADHD who require medication.

ADHD medication prescribed for your child should not be taken by you or your other children. Your children should not take, nor should you give them, ADHD medication prescribed for you.

If you have been diagnosed with ADHD and you have children, you should speak with their pediatrician to help identify any signs of ADHD that may be present in your children. ADHD is now one of the most common and most studied pediatric conditions. Due to greater awareness and better ways of diagnosing and treating this disorder, more children are being helped.

ADHD treatment

Talk to your child’s doctor. Be sure to communicate any questions or concerns you may have. That way, the doctor can properly evaluate your child and determine what is the best treatment path forward.

An ADHD treatment plan that includes non-medication treatments, like behavior therapy and parent training, may be used before medication is tried. If your child’s doctor determines that medication should also be part of your child’s treatment plan, there are different options available.

FDA-approved medications for the treatment of ADHD include stimulants and non-stimulants. Stimulant ADHD treatments fall into the category of methylphenidate or amphetamine. A healthcare professional’s decision to prescribe either a methylphenidate like Quillivant XR® (methylphenidate HCI) or QuilliChew ER® (methylphenidate HCI) or an amphetamine like DYANAVEL® XR (amphetamine) liquid or DYANAVEL® XR (amphetamine) tablet ultimately depends on a few key factors:

  • The patient’s individual needs
  • Prior experience with methylphenidates or amphetamines
  • Any other health conditions the patient may have or other medications the patient may be taking

Methylphenidates and amphetamines are both classified as stimulants. As they can work differently in the body, patients may respond differently to each.

Children who are newly diagnosed with ADHD and are prescribed ADHD medication for the first time usually start with a methylphenidate. Amphetamines, which tend to be a bit more potent and last longer, are typically prescribed to adults with ADHD, to teenagers who have previously taken a methylphenidate, or to those who do not respond to methylphenidates.

Besides stimulants, like methylphenidates and amphetamines, non-stimulants are also used to treat ADHD. Non-stimulants may be prescribed to a patient when stimulant medications have either not been effective or have been shown to cause unwanted side effects for the patient. For patients whose ADHD has resulted in anxiety or depression, doctors may prescribe an antidepressant, as well.

Medication is only one option for treating ADHD. ADHD education, behavior therapy including skills training and parent training, and school accommodations can all play an important role in an ADHD treatment plan. While a combination of medication and behavior therapy is typically recommended, only your or your child’s doctor can help determine whether medication is necessary to manage ADHD symptoms.

Learn more about ADHD with resources available to you and your family.

tris pharma dyanavel adhd children playing instruments

Access ADHD resources

Find helpful resources and links containing information about ADHD, ADHD support programs, Tris Pharma products, and access to medications and savings.

Did you know that you may be able to save on your or your child’s ADHD medication?*

DYANAVEL XR Tablet
Tris Pharma Dyanavel XR ADHD Savings Card
OR
Quillivant XR • QuilliChew ER
DYANAVEL XR Liquid
Tris Pharma ADHD Copay Savings Card
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 available at coupon.trisadhd.com/terms. Message and Data rates may apply.

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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