IMPORTANT SAFETY INFORMATION
WARNING: ABUSE AND DEPENDENCE
- CNS stimulants (amphetamines and methylphenidate-containing products) have a high potential for abuse
- Assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on
- 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.
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.
- Vyvanse (lisdexamfetamine dimesylate) [package insert]. Wayne, PA: Shire Us Inc.