This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US health care professionals only.

WARNING: ABUSE AND DEPENDENCE

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

Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

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IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

  • CNS stimulants (amphetamines and methylphenidate-containing products), including Vyvanse, have a high potential for abuse and dependence. Assess the risk of abuse prior to prescribing; monitor for signs of abuse and dependence during therapy.
  • Contraindications
    Patients should not take Vyvanse if they are:
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking monoamine oxidase inhibitors (MAOI) or have taken an MAOI within the past 14 days. Hypertensive crisis can occur.
  • Warnings and Precautions
    • Prior to and during 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. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can cause increases 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.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients with ADHD. Monitor weight and height in children during treatment with Vyvanse for ADHD. Treatment may need to be interrupted in children not growing as expected.
    • CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
  • Adverse Reactions
    The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in ADHD 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.

    The most common adverse reactions (≥ 5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, feeling jittery, constipation, and anxiety.
  • Other Considerations
    • Safety and effectiveness in patients <18 years with B.E.D. have not been established.

INDICATION AND LIMITATION OF USE

Vyvanse (lisdexamfetamine dimesylate) is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above, and for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. Vyvanse is not indicated or recommended for weight loss. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. The safety and effectiveness of Vyvanse for the treatment of obesity have not been established.

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

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