IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence.
  • Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of ADHD in patients ages 6 and above.

When Your Patient's Day Changes, ADHD Symptoms Can Change Too1

When assessing patients with ADHD, consider that symptoms may vary within settings.1

LEARN MORE

SAVINGS OFFER

Help eligible patients pay no more than $30 per prescription**Restrictions apply

Register

Formulary Coverage

Look up formulary coverage and co-pay information

Explore

CLINICAL RESULTS

View Vyvanse clinical trial results

Read

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse and dependence.
  • Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy.
  • Contraindications:
    • Known hypersensitivity to amphetamines or other ingredients in Vyvanse. Anaphylactic reactions, Stevens - Johnson syndrome, angioedema, and urticaria have been observed in postmarketing reports.
    • Concurrent administration of monoamine oxidase inhibitors (MAOI) or administration of Vyvanse within 14 days of the last MAOI dose. Hypertensive crisis can occur.
  • Educate patients about abuse and periodically re-evaluate the need for Vyvanse.
  • Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in children and adolescents with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD. Prior to treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during Vyvanse treatment.
  • CNS stimulants cause an increase in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
  • Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use.
  • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
  • Stimulants used to treat ADHD, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Careful observation for digital changes (e.g., numbness, pain, skin color change, or sensitivity to temperature, and rarely ulcerations and/or soft tissue breakdown) is necessary during treatment and may require further evaluation (e.g., referral).
  • The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
    • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth and dizziness;
    • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
    • Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety and anorexia.

INDICATION

Vyvanse is indicated for the treatment of ADHD in patients ages 6 and above.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

Reference

  1. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5®). Arlington, VA: American Psychiatric Association; 2013.

Shire ©2014 Shire US Inc. Wayne, PA 19087. 1-800-828-2088 All rights reserved. Vyvanse® is a registered trademark of Shire LLC.

All content of this Web site including text, images, graphics, sound files, and their arrangements, belongs to Shire and is protected by international copyrights laws. All other intellectual property rights are reserved. The content may not be copied for commercial use or distribution nor may these objects be downloaded, modified, or posted to other sites.

This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our online privacy policy for more information. While Shire US Inc. makes reasonable efforts to include accurate, up-to-date information on the site, Shire US Inc. makes no warranties or representations as to its accuracy. Shire US Inc. assumes no liability for any errors or omissions in the content of the site.

S03990  11/14

You are about to leave vyvansepro.com.

Please be advised that Shire Pharmaceuticals has no control over the content or presentation of the site you are about to view.

Cancel Continue