This site is intended for US residents only.

EVEKEO is another approach to ADHD therapy

What is EVEKEO?

EVEKEO® CII (amphetamine sulfate tablets, USP) is a prescription medicine for the treatment of narcolepsy, attention-deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short term adjunct in a regimen of weight reduction.1

EVEKEO is the ONLY ADHD stimulant therapy with a 1:1 racemic mixture of dextroamphetamine and levoamphetamine.1,2

EVEKEO is the only ADHD medicine that is half dextroamphetamine and half levoamphetamine.1,2

How does EVEKEO work to treat children with ADHD?

EVEKEO is a type of ADHD medicine called a stimulant.

  • Stimulants help networks in the brain communicate with each other better3
  • Taking a stimulant for ADHD symptoms might make it easier to pay attention and focus, and control hyperactive and impulsive behavior3

Who can take EVEKEO?

EVEKEO is approved for use in children with ADHD who are 3 years of age and up.1

When might EVEKEO be the right choice?

Actually, that’s up to you and the healthcare provider. Symptoms vary from patient to patient, so ADHD treatment should be individualized. EVEKEO can be used to treat childhood ADHD if the two of you decide it’s the appropriate choice. Just remember, the more you know about EVEKEO, the better conversation you will be able to have with the healthcare provider.

50% levoamphetamine.
50% dextroamphetamine.

Read about the EVEKEO classroom study of children with ADHD
Get answers to frequently asked questions

References: 1. Evekeo [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC. 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. 3. National Resource Center on ADHD: A program of CHADD. What We Know 3. Managing medication for children and adolescents with ADHD. http//www.help4adhd.org. Accessed May 23. 2016.

IMPORTANT SAFETY INFORMATION

INDICATION

Evekeo® (amphetamine sulfate tablets, USP) is a prescription medicine for the treatment of narcolepsy, attention deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short term adjunct in a regimen of weight reduction.

Evekeo is a federally controlled substance (CII) with a high risk of abuse or dependence. Prolonged use may lead to drug dependence and must be avoided. Subjects may obtain Evekeo for illegal non- therapeutic use or distribution to others, and therefore it should be prescribed or dispensed sparingly.

Misuse of Evekeo may cause sudden death and serious cardiovascular adverse events.

Do not take Evekeo if you or your child:

  • has a history of advanced heart disease or hardening of the arteries, moderate to severe high blood pressure, hyperthyroidism, known hypersensitivity or other serious cardiac problems that may place you or your child at increased vulnerability to the sympathomimetic effects of a stimulant drug
  • is very anxious, tense or agitated
  • has a history of drug abuse
  • is taking or has taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor (MAOI)
  • is sensitive to, allergic to, or had a reaction to other stimulant medicines

Warnings and Precautions

Serious heart problems can occur when taking stimulant medicines, such as Evekeo, and can include:

  • sudden death in people 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 including heart defects, abnormal heart rhythm, high blood pressure, disease known as cardiomyopathy, coronary artery disease, or a family history of these problems or sudden cardiac death. 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 Evekeo.

Mental (psychiatric) problems can occur including:

  • new or worse behavior and thought problems
  • new or worse bipolar illness
  • new or worse aggressive behavior or hostility

New aggressive behavior or psychotic symptoms can occur in children and teenagers such as:

  • seeing things or hearing voices
  • believing things that are not true
  • being suspicious
  • new manic problems

Tell your doctor about any drug abuse, alcohol abuse or mental problems that you or your child has had or about a family history of suicide, bipolar illness or depression, new or worsening aggressive behavior or hostility.Call your doctor right away if you or your child has any new or worsening mental symptoms while taking Evekeo.


Circulation problems in fingers and toes:

  • 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 or your child has any numbness, pain, color change, or sensitivity to temperature in your fingers and toes or a family history of health conditions including circulation problems in fingers and toes. Call your doctor right away if you or your child has any signs of unexplained wounds appearing on fingers and toes while taking Evekeo.


Evekeo may cause serious side effects including:

  • slowing of growth (height and weight) in children, seizures, eyesight changes or blurred vision, and serotonin syndrome. Serotonin syndrome can be life threatening and happens when Evekeo is taken with certain medicines. Symptoms include agitation, hallucinations, coma or other changes in mental status, problems controlling your movements or muscle twitching, fast heartbeat, high or low blood pressure, sweating or fever, nausea or vomiting, diarrhea, and muscle stiffness or tightness

The most common side effects reported with Evekeo include:

  • headache, stomach ache, trouble sleeping, decreased appetite, unpleasant taste, nervousness, dizziness, sexual problems (impotence in males), vomiting, itching, diarrhea or constipation, dry mouth, weight loss, and mood swings

Talk to your doctor if you or your child have side effects that are bothersome or do not go away, if you or your child is pregnant, plan on becoming pregnant, or are breast-feeding, about all health conditions (or a family history of), and about the medicines you or your child take. Your doctor will decide whether Evekeo can be taken with other medicines and if Evekeo is right for your child.

For additional safety information, consult the Evekeo full Prescribing Information and Medication Guide.

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.

INDICATION

Evekeo® (amphetamine sulfate tablets, USP) is a prescription medicine for the treatment of narcolepsy, attention deficit disorder with hyperactivity as an integral part of a total treatment program and exogenous obesity as a short-term adjunct in a regimen of weight reduction.

IMPORTANT SAFETY INFORMATION

Evekeo is a federally controlled substance (CII) with a high risk of abuse or dependence. Prolonged use may lead to drug dependence and must be avoided. Subjects may obtain Evekeo for illegal non- therapeutic use or distribution to others, and therefore it should be prescribed or dispensed sparingly.

Misuse of Evekeo may cause sudden death and serious cardiovascular adverse events.

Contraindications

Evekeo is contraindicated in patients:

  • with a history of advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines
  • that are tense or agitated
  • with a history of drug abuse
  • taking or who have taken monoamine oxidase inhibitor (MAOI) within 14 days. Hypertensive crises may result.

Warnings and Precautions

Sudden death has been reported in children and adolescents with structural cardiac abnormalities or other serious heart problems in association with CNS stimulant treatment at usual doses. Sudden death, stroke and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Stimulant medications can cause an increase in blood pressure (mean increase about 2-4 mmHg) and heart rate (mean increase about 3-6 bpm). All patients should be monitored for larger changes in heart rate and blood pressure.


Children, adolescents, or adults who are being considered for treatment with Evekeo should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease. Patients developing any signs of heart problems such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease while taking Evekeo should undergo a prompt cardiac evaluation.


Stimulants may exacerbate symptoms in patients with pre-existing psychotic disorder or in patients with new or worsening bipolar disorder. Treatment emergent psychotic or manic symptoms can occur in children or adolescents such as hallucinations, delusional thinking, or mania. Aggressive behavior or hostility is also often observed in children and adolescents taking medications for ADHD and should be monitored for the-appearance of or worsening of aggressive behavior or hostility.


Stimulants have been associated with long-term suppression of growth in pediatric patients. Growth should be monitored during treatment with Evekeo, and patients not growing or gaining height or weight as expected may need to have their treatment interrupted.


Stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.


Stimulants used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects were observed in post‐marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.


Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as MAOIs, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort. See DRUG INTERACTIONS in the prescribing information for all Evekeo interactions. The potential for a pharmacokinetic interaction exists with the co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to Evekeo. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6.


Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular symptoms, seizures, and/or gastrointestinal symptoms. Concomitant use of Evekeo with MAOI drugs is contraindicated. Discontinue treatment with Evekeo and any concomitant serotonergic agents immediately if the above symptoms occur and initiate supportive symptomatic treatment. If concomitant use of Evekeo with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Evekeo with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.


Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.


Adverse Reactions

The most common side effects reported with Evekeo treatment include palpitations, tachycardia, hypertension, cardiomyopathy (with chronic use), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of phonic tics and Tourette's syndrome, dry mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances, anorexia and weight loss, urticaria impotence, changes in libido, frequent or prolonged erections, and rhabdomyolysis.


For additional safety information, consult the Evekeo full Prescribing Information and Medication Guide. 

You are encouraged to report side effects of prescription drugs to Azurity Pharmaceuticals, Inc. at 1-800-461-7449 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.


© 2022 Arbor Pharmaceuticals, LLC, a subsidiary of Azurity Pharmaceuticals, Inc.

Sometimes a change is needed for the right patients!

Click here to find out more!