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Shire To Initiate Two Phase 4 Clinical Trials To Compare Vyvanse® (lisdexamfetamine Dimesylate) Capsules, (CII) To Concerta® (methylphenidate HCl) Extended-Release Tablets, (CII)

IMPORTANT SAFETY INFORMATION

WARNING: POTENTIAL FOR MISUSE, ABUSE, ADDICTION, AND DIVERSION

See Full Prescribing Information for complete Boxed WARNING.

• Vyvanse is a Schedule II controlled substance. Stimulants, such as amphetamines and methylphenidates, are subject to misuse, abuse, addiction, and criminal diversion.

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

Contraindications: Known hypersensitivity to amphetamines or other ingredients in Vyvanse.

Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have been observed in postmarketing reports. Using Vyvanse with monoamine oxidase inhibitors (MAOIs) can result in hypertensive crisis. Stop MAOIs at least 14 days prior to Vyvanse use.

Sudden death, stroke and myocardial infarction have been reported with stimulants at usual doses for the treatment of ADHD. Stimulants generally should not be used in patients with known structural cardiac abnormalities or other serious heart problems. Adults have a greater likelihood than children of having such cardiac disease. Patients being considered for stimulant treatment should have a careful history (including family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease. Further evaluation should be conducted if needed (eg, electrocardiogram and echocardiogram). Patients who develop symptoms suggestive of cardiac disease (eg, exertional chest pain, unexplained syncope) during stimulant treatment should undergo a prompt evaluation.

Use with caution in patients whose underlying medical condition might be compromised by increases in blood pressure or heart rate. Stimulants cause modest increases in average blood pressure (about 2-4 mmHg) and average heart rate (about 3-6 bpm) and patients may have larger increases. Monitor all patients for larger changes.

Use of stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis. Clinical evaluation for bipolar disorder is recommended prior to stimulant use. Monitor for aggressive behavior.

Monitor growth in children during treatment with Vyvanse. Children who are not growing (gaining height or weight) as expected may need to have their treatment interrupted.

Stimulants may lower the convulsive threshold. Discontinue if seizures develop.

Visual disturbances and exacerbation of tics and Tourette's syndrome have been reported with stimulant treatment.

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, decreased weight, vomiting, nausea, dizziness and dry mouth;
  • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
  • Adults: decreased appetite, insomnia, dry mouth, nausea, diarrhea, anxiety and anorexia.

Please click here for   Full PrescribingInformation  for Vyvanse (lisdexamfetamine dimesylate), including Boxed WARNING regarding Potential for Misuse, Abuse, Addiction, and Diversion .

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