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Dyanavel XR

Generic Name: amphetamine extended-release oral suspension
Date of Approval: October 19, 2015
Company: Tris Pharma, Inc.

FDA Approves Dyanavel XR

Dyanavel XR is the first, extended-release amphetamine-based oral liquid for the treatment of ADHD

The U.S. Food and Drug Administration (FDA) has approved Dyanavel XR (amphetamine) extended-release oral suspension for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years and older.

Medication Guide

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor.

Important information

Dyanavel XR is a federally controlled substance (CII) because it can be abused or lead to dependence. Keep this medicine in a safe place to prevent misuse and abuse. Selling or giving it away may harm others and is against the law.

Tell your doctor if you or your child has ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Dyanavel XR is a stimulant medicine. Some patients have had the following problems when taking stimulant medicines. The following have been reported with use of methylphenidate hydrochloride and other stimulant medicines.

  1. Heart-related problems:
    • sudden death in patients who have heart problems or heart defects
    • sudden death, stroke and heart attack in adults
    • increased blood pressure and heart rate
    Tell your doctor if you or your child has any heart problems, heart defects, high blood pressure, or a family history of these problems.
    Your doctor should check you or your child carefully for heart problems before starting treatment.
    Your doctor should check your or your child’s blood pressure and heart rate regularly during treatment.
    Call your doctor right away if you or your child has any signs of heart problems such as chest pain, shortness of breath, or fainting while taking Dyanavel XR.
  2. Mental (Psychiatric) problems:
    • new or worse behavior and thought problems
    • new or worse bipolar illness
    • new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms
    Tell your doctor about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
    Call your doctor right away if you have or your child has any new or worsening mental symptoms or problems while taking Dyanavel XR, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.
  3. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon]:
    • fingers or toes may feel numb, cool, painful
    • fingers or toes may change color from pale, to blue, to red
    Tell your doctor if you have or your child has numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.
    Call your doctor right away if you have or your child has any signs of unexplained wounds appearing on fingers or toes while taking Dyanavel XR.

What is Dyanavel XR?

Dyanavel XR is a central nervous system stimulant prescription medicine. It is used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD). It may help increase attention and decrease impulsiveness and hyperactivity in patients with ADHD.

It is not known if Dyanavel XR is safe and effective in children under 6 years of age.

Who should not take Dyanavel XR?

Dyanavel XR should not be taken if you or your child:

  • are allergic to amphetamine, or any of the inactive ingredients listed at the end of this Medication Guide.
  • are taking or have taken within the past 14 days an antidepressant medicine called a monoamine oxidase inhibitor or MAOI.

Before taking Dyanavel XR

Dyanavel XR may not be right for you or your child. Before starting treatment, tell your or your child’s doctor about all health conditions (or a family history of) including:

  • heart problems, heart defects, or high blood pressure
  • mental problems including psychosis, mania, bipolar illness, or depression
  • circulation problems in fingers and toes

Tell your doctor:

  • if you or your child have any kidney problems. Your doctor may lower the dose.
  • if you are or your child is pregnant, or plan to become pregnant. It is not known if this medicine will harm your unborn baby.
  • If you are or your child is breastfeeding or plan to breastfeed. Dyanavel XR passes into breast milk. Talk to your doctor before you breastfeed if you or your child are taking Dyanavel XR.

Tell your doctor about all of the medicines that you or your child takes including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Dyanavel XR and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be adjusted while taking Dyanavel XR. Your doctor will decide whether Dyanavel XR can be taken with other medicines.

Especially tell your doctor if you or your child takes:

  • antidepressant medicines including MAOIs

Know the medicines that you or your child take. Keep a list of your medicines with you to show your doctor and pharmacist.Do not start any new medicine while taking Dyanavel XR without talking to your doctor first.

How should Dyanavel XR be taken?

  • Take this medicine exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
  • Take the dose of the oral suspension one time each day in the morning.
  • The dose can be taken with or without food.
  • Shake the bottle well before you use it.
  • Use an oral dosing syringe or other measuring device to help you measure the right amount of Dyanavel XR.
  • Your doctor may sometimes stop your treatment for a while to check your ADHD symptoms.
  • Your doctor may do regular checks of your or your child’s blood, heart, and blood pressure during treatment.
  • Children should have their height and weight checked often during treatment. Dyanavel XR treatment may be stopped if a problem is found during these check-ups.
  • If you or your child take(s) too much Dyanavel XR, call your doctor or poison control center at 1-800-222-1222 right away, or go to the nearest hospital emergency room.

What should I avoid while taking Dyanavel XR?

  • drinking alcohol

Dyanavel XR side effects

Dyanavel XR can cause serious side effects, including:

  • See Important information for information on reported heart and mental problems.
  • slowing of growth (height and weight) in children

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.

These are not all the possible side effects of Dyanavel XR. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

How should I store Dyanavel XR?

  • Store Dyanavel XR at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store the medicine in a safe place, like a locked cabinet.
  • Dispose of remaining, unused, or expired Dyanavel XR by a medicine take-back program at authorized collection sites such as retail pharmacies, hospital or clinic pharmacies, and law enforcement locations. If no take-back program or authorized collector is available, mix Dyanavel XR with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. Place the mixture in a container such as a sealed plastic bag and throw away in the household trash.

Keep all medicines out of the reach of children.

General information about the safe and effective use of Dyanavel XR

Medicines are sometimes prescribed for purposes other than those listed in the Medication Guide. Do not use Dyanavel XR for a condition for which it has not been prescribed. Do not give it to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Dyanavel XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information that is written for healthcare professionals.

What are the ingredients in Dyanavel XR?

Active Ingredient: amphetamine.

Inactive Ingredients: anhydrous citric acid, bubblegum flavor, glycerin, methylparaben, modified food starch, polysorbate 80, povidone, polyvinyl acetate, propylparaben, sodium lauryl sulfate, sodium polystyrene sulfonate, sucralose, triacetin and xanthan gum.