Higher-strength racemic amphetamine available

to treat Attention Deficit Hyperactivity Disorder (ADHD) in children ages 6-17

An IR* ADHD stimulant therapy with a balanced 1:1 racemic mixture of levoamphetamine and dextroamphetimine available in 15-mg and 20-mg strengths as an orally disintegrating tablet formulation.1,2

*Immediate-Release.

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Important Safety Information

EVEKEO ODT® (amphetamine sulfate) is a central nervous system (CNS) stimulant prescription medicine used for the treatment of:

  • Attention Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. EVEKEO ODT may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD.

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

EVEKEO ODT is a federally controlled substance (CII) because it contains amphetamine that can be a target for people who abuse prescription medicines or street drugs. Keep EVEKEO ODT in a safe place to protect it from theft. Never give your EVEKEO ODT to anyone else because it may cause death or harm them. Selling or giving away EVEKEO ODT may harm others and is against the law.

WARNING: ABUSE, MISUSE, AND ADDICTION

See full prescribing information for complete boxed warning.

EVEKEO ODT has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including EVEKEO ODT, can result in overdose and death:

  • Before prescribing EVEKEO ODT, assess each patient’s risk for abuse, misuse, and addiction.
  • Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug.
  • Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

ADDITIONAL IMPORTANT SAFETY INFORMATION

Do not take EVEKEO ODT if you or your child:

  • are allergic to amphetamine products or any of the ingredients in EVEKEO ODT.
  • are taking or have stopped taking in the last 14 days, a medicine used to treat depression called a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid and the intravenous medicine methylene blue. Ask your healthcare provider or pharmacist if you are not sure if you or your child take one of these medicines.

What is the most important information I should know about EVEKEO ODT?

EVEKEO ODT may cause serious sides effects, including:

Abuse, misuse, and addiction. EVEKEO ODT has a high potential for abuse and misuse and may lead to substance use problems, including addiction. Misuse and abuse of EVEKEO ODT, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of EVEKEO ODT or when it is used in ways that are not approved, such as snorting or injection.

  • Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with EVEKEO ODT and will monitor you or your child during treatment.
  • EVEKEO ODT may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider.
  • Do not give EVEKEO ODT to anyone else.
  • Keep EVEKEO ODT in a safe place and properly dispose of any unused medicine.
  • Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Risks for people with serious heart problems. Sudden death has happened in people who have heart defects or other serious heart disease.

Your healthcare provider should check you or your child carefully for heart problems before starting treatment with EVEKEO ODT. Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects.

Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with EVEKEO ODT.

Increased blood pressure and heart rate. Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with EVEKEO ODT.

Mental (psychiatric) problems can occur including:

  • new or worsening behavior and thought problems.
  • new or worsening bipolar illness.
  • new psychotic symptoms (such as hearing voices, or seeing, or believing things that are not real) or new manic symptoms.

Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.

Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with EVEKEO ODT, especially hearing voices, seeing, or believing things that are not real, or new manic symptoms.

Before taking EVEKEO ODT, tell your healthcare provider about all medical conditions, including if you or your child:

  • have heart problems, heart disease, heart defects, or high blood pressure.
  • have mental problems including psychosis, mania, bipolar illness, or depression, or have a family history of suicide, bipolar illness, or depression.
  • have seizures (convulsions) or have had an abnormal brain wave test (EEG).
  • have circulation problems in fingers and toes.
  • have or had repeated movements or sounds (tics) or Tourette’s syndrome or have a family history of tics or Tourette’s syndrome.
  • are pregnant or plan to become pregnant. It is not known if EVEKEO ODT will harm the unborn baby.
    • There is a pregnancy registry for females who are exposed to EVEKEO ODT during pregnancy. The purpose of the registry is to collect information about the health of females exposed to EVEKEO ODT and their baby. If you or your child becomes pregnant during treatment with EVEKEO ODT, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visit online at https://womensmentalhealth.org/clinicaland-research-programs/pregnancyregistry/othermedications/
  • are breastfeeding or plan to breastfeed. EVEKEO ODT passes into breast milk. You or your child should not breastfeed during treatment with EVEKEO ODT. Talk to your healthcare provider about the best way to feed the baby during treatment with EVEKEO ODT.

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

EVEKEO ODT and some medicines may interact with each other and cause serious side effects. Sometimes the doses of other medicines will need to be changed during treatment with EVEKEO ODT.

Especially tell your healthcare provider if you or your child take medicines used to treat depression including MAOIs.

Know the medicines that you or your child take. Keep a list of your or your child’s medicines with you to show your healthcare provider and pharmacist when you or your child get a new medicine. Do not start any new medicine during treatment with EVEKEO ODT without talking to your healthcare provider first.

What are possible side effects of EVEKEO ODT?

EVEKEO ODT may cause serious side effects, including:

  • Slowing of growth (height and weight) in children. Children should have their height and weight checked often during treatment with EVEKEO ODT. Your healthcare provider may stop your child’s EVEKEO ODT treatment if they are not growing or gaining weight as expected.
  • Seizures (convulsions). Your healthcare provider may stop treatment with EVEKEO ODT if you have a seizure.
  • Circulation problems in fingers and toes (peripheral vasculopathy, including Raynaud’s phenomenon). Signs and symptoms may include:
    • fingers or toes may feel numb, cool, painful.
    • fingers or toes may change color from pale, to blue, to red.

Tell your healthcare provider if you or your child have numbness, pain, skin color change, or sensitivity to temperature in your fingers or toes.

Call your healthcare provider right away if you or your child have any signs of unexplained wounds appearing on fingers or toes during treatment with EVEKEO ODT.

  • 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 with EVEKEO ODT.
  • Serotonin Syndrome. A potentially life-threatening problem called serotonin syndrome may happen when EVEKEO ODT is taken with certain other medicines. Stop taking EVEKEO ODT and call your healthcare provider or go to the nearest hospital emergency room right away if you or your child develop any of the following signs and symptoms of serotonin syndrome:
    • Agitation
    • confusion
    • fast heart beat
    • dizziness
    • flushing
    • tremors, stiff muscles, or muscle twitching
    • seizures
    • seeing or hearing things that are not real (hallucination)
    • coma
    • changes in blood pressure
    • sweating
    • high body temperature (hyperthermia)
    • loss of coordination
    • nausea, vomiting, diarrhea

The most common side effects of EVEKEO ODT include decreased appetite and trouble sleeping.

These are not all the possible side effects of EVEKEO ODT. Please see Full Prescribing Information for a full list.

The Important Safety Information does not include all the information needed to use EVEKEO ODT safely and effectively. Please see accompanying full Prescribing Information for EVEKEO ODT.

To Report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PP-EVK-US-0074

References:

  • 1. EVEKEO ODT® [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2022.
  • 2. Childress AC, Brams M, Cutler AJ, et al. The efficacy and safety of Evekeo, racemic amphetamine sulfate, for treatment of attention-deficit/hyperactivity disorder symptoms: a multicenter, dose-optimized, double-blind, randomized, placebo-controlled crossover laboratory classroom study. J Child Adolesc Psychopharmacol. 2015;25(5):402-414.