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

305 Study: Efficacy Assessed in Patients Aged 13-17 Years Using ADHD-RS-IV1

Explore the clinical study design of Vyvanse as a treatment for adolescent patients with ADHD Vyvanse demonstrated a significant reduction in ADHD-RS-IV total score for adolescents aged 13-17 years with ADHD¹

  • Randomized, double-blind, parallel-group, placebo-controlled, 4-week trial with forced-dose escalation in 314 teens aged 13 to 17 years with ADHD based on the DSM-IV-TR® to evaluate the safety and efficacy of Vyvanse 30, 50, and 70 mg/day compared with placebo1,2
  • Primary Endpoint: Change from baseline to endpoint* in ADHD-RS-IV total score1,2
  • ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, a validated, investigator-rated measure that consists of 18 items designed to reflect the symptomatology of ADHD based on DSM-IV-TR® criteria.
  • DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
  • *Last post-randomization treatment week for which a valid ADHD-RS-IV total score was obtained.
PATIENT CHARACTERISTICS1,2:
  • Diagnosis of ADHD based on DSM-IV-TR® criteria
  • Baseline ADHD-RS-IV total score ≥28
PRIMARY ENDPOINT: Change from baseline to endpoint in ADHD-RS-IV total score1-3

Significant reduction in ADHD-RS-IV total score with Vyvanse compared to placebo*

Mean Change in ADHD-RS-IV total score from baseline to endpoint1,3

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

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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