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Dosing Flexibility1

Flexible, Individualized Dosing1

DYANAVEL® XR (amphetamine) lets you or your child start medication slowly

DYANAVEL XR should be taken by mouth once every day in the morning.

  • Your healthcare provider may start DYANAVEL XR at a low dose and individualize the dose by adjusting it up or down in small amounts based on your or your child’s treatment response
  • DYANAVEL XR comes with an oral dosing dispenser that will help you measure the amount of medication
  • DYANAVEL XR can be taken with or without food
  • Take DYANAVEL XR exactly as prescribed and remember to shake the bottle well (up and down) prior to each use

How to take DYANAVEL XR

Read the Instructions for Use for DYANAVEL XR you received from your pharmacist before taking DYANAVEL XR and every time you get a refill so that you have the most up-to-date instructions.

If you have any questions, talk to your healthcare provider about your or your child’s medical condition or treatment.

How To Take DYANAVEL XR Amphetamine Step 1: Oral Dosing Dispenser & Bottle Adapter

Step 1

  • Check the DYANAVEL XR bottle to make sure that the bottle adapter has been inserted into the bottle by the pharmacist. Do not remove the bottle adapter.
  • Check to make sure your pharmacist has given you an oral dosing dispenser.
  • Tell your pharmacist if an oral dosing dispenser is not provided or the bottle adapter is missing from the neck of the bottle.

How To Take DYANAVEL XR Amphetamine Step 2: Shake Bottle

Step 2

  • Shake the bottle well (up and down).

How To Take DYANAVEL XR Amphetamine Step 3: Check Oral Dosing Dispenser

Step 3

  • Check the DYANAVEL XR oral dosing dispenser to find the right dose in milliliters (mL) that you or your child’s healthcare provider has prescribed.

How To Take DYANAVEL XR Amphetamine Step 4 & 5: Insert Oral Dosing-Dispenser & Push Plunger

Step 4

  • Place the DYANAVEL XR bottle upright and insert tip of the oral dosing dispenser into the bottle.

Step 5

  • Push the plunger all the way down.

How To Take DYANAVEL XR Amphetamine Step 6: Pull Plunger

Step 6

  • With the oral dosing dispenser in place, hold the DYANAVEL XR bottle with 1 hand and turn the bottle upside down. Pull the plunger down until the white end of the plunger reaches the number of mLs you need for the prescribed dose.

How To Take DYANAVEL XR Amphetamine Step 7: Remove Oral Dosing Dispenser

Step 7

  • Turn the bottle over and place upright on a counter top, then remove the oral dosing dispenser from the bottle adapter.

How To Take DYANAVEL XR Amphetamine Step 8: Dispense Into Mouth

Step 8

  • Place the tip of the oral dosing dispenser into your or your child’s mouth. Point the tip toward the cheek and slowly push the plunger all the way down to give the DYANAVEL XR dose.

How To Take DYANAVEL XR Amphetamine Step 9: Close Cap

Step 9

  • Put the DYANAVEL XR cap back on the bottle and close tightly.

How To Take DYANAVEL XR Amphetamine Step 10: Clean Oral Dosing Dispenser

Step 10

  • Clean the oral dosing dispenser after each use by placing in the dishwasher, or by rinsing with tap water.

Keep DYANAVEL XR and all medicines out of the reach of children.

Learn about the steady medication release of DYANAVEL XR

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

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 a target for people who abuse prescription medicines or street drugs. DYANAVEL XR, Quillivant XR, and QuilliChew ER have 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.

See Additional Important Safety Information.

Important Safety Information & Approved Use

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

  • 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 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, Misuse and Addiction.

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