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.

IMPORTANT SAFETY INFORMATION

DYANAVEL XR, Quillivant XR, and QuilliChew ER are federally controlled substance (CII) because they can be a target for people who abuse prescription medicines or street drugs. DYANAVEL XR, Quillivant XR, and QuilliChew ER has 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.
• 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.
• 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 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 QuilliChew ER during pregnancy. The purpose of the registry is to collect information about the health of females exposed to QuilliChew ER and their baby. If you or your child becomes pregnant during treatment with 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 breast feed 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:

Common side effects of methylphenidate products include:

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.

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

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