For attention-deficit/hyperactivity disorder (ADHD)

Another Approach to Pediatric
ADHD Treatment

Evekeo: The ONLY ADHD stimulant therapy with a 1:1 racemic mixture of levoamphetamine and dextroamphetamine1,2

ADHD is a neurological disorder recognized by such organizations as the American Academy of Pediatrics, American Medical Association, American Academy of Family Physicians, and the American Psychiatric Association.3-6 Recent data suggest that more than 6 million school-aged children in the United States have been diagnosed with ADHD at one time.7

Evekeo® CII (amphetamine sulfate tablets, USP) has been available in the United States since 2015. Evekeo has been studied in a laboratory classroom with data covering ADHD-RS-IV, PERMP, and SKAMP.

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. Subcommittee on Attention-Deficit/Hyperactivity Disorder, Steering Committee on Quality Improvement and Management. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2011;128(5):1007-1022. 4. American Medical Association. Diagnosis and treatment of attention deficit/hyperactivity disorder in school-age children H-60.950. https://searchpf.ama-assn.org/SearchML/searchDetails.action?uri=%2FAMADoc%2FHOD.xml-0-5044.xml. Accessed May 25, 2016. 5. American Academy of Family Physicians. Clinical practice guideline. ADHD in children and adolescents. http://www.aafp.org/patient-care/clinical-recommendations/all/ADHD.html. Accessed April 27, 2016. 6. American Psychiatric Association. Attention deficit/hyperactivity disorder. http://www.dsm5.org/documents /adhd%20fact%20sheet.pdf. Accessed April 27, 2016. 7. Visser SN, Danielson ML, Bitsko RH, et al. Trends in the parent-report of health care provider diagnosed and medicated ADHD: United States, 2003-2011. J Am Acad Child Adolesc Psychiatry. 2014;53(1):34-46.e2. doi:10.1016/j.jaac.2013.09.001.

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.

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, constipation, gastrointestinal disturbances, anorexia and weight loss, urticaria, impotence, changes in libido, frequent or prolonged erections, and rhabdomyolysis.


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.

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