INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above. 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.

This site is intended for US healthcare professionals only.

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 and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in patients ages 6 and above. 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.

IMPORTANT SAFETY INFORMATION    This site is intended for US healthcare 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 and monitor for signs of abuse and dependence while on therapy.
Full Safety Information Below

303 Study: 4-Week Trial With Forced Dose Escalation

Explore the clinical study design of Vyvanse as a treatment for adult patients with ADHD Vyvanse significantly improved ADHD symptoms in adults¹

  • Randomized, double-blind, parallel-group, placebo-controlled, 4-week trial with forced dose escalation in 420 adult subjects aged 18-55 years with ADHD (based on DSM-IV-TR®) to evaluate the safety and efficacy of Vyvanse 30, 50, and 70 mg/day compared with placebo1,2
  • Primary Endpoint: Mean change from baseline to endpoint* in ADHD-RS-IV total score1,2
  • DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
  • ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, with Adult Prompts, an investigator-rated measure of the core symptoms of ADHD.
  • *Endpoint was defined as the last post-randomization treatment week for which a valid score was obtained.
PATIENT CHARACTERISTICS1,2

In a study of 420 randomized subjects:

PRIMARY ENDPOINT: Mean change from baseline to endpoint in ADHD-RS-IV total score1-3

Vyvanse significantly improved ADHD symptoms in adults

Mean change from baseline in ADHD-RS-IV total score at endpoint1,2

  • *Average of all doses tested.
  • P<.0001 for Vyvanse vs. placebo at endpoint.2

IMPORTANT SAFETY INFORMATION (cont’d)

  • 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 (MAOIs) or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis.

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