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

301 Study: Efficacy Assessed in Patients Aged 6-12 Years Using ADHD-RS-IV and CPRS ADHD Index

Explore the clinical study design of Vyvanse as a treatment for pediatric patients with ADHD Vyvanse demonstrated a significant reduction in ADHD-RS-IV total score for children aged 6-12 with ADHD1,3

  • Randomized, double-blind, parallel-group, placebo-controlled, forced-dose escalation, 4-week study to assess the efficacy and safety of Vyvanse 30 mg, 50 mg, or 70 mg/day compared with placebo in 290 children aged 6-12 years with ADHD (as defined by DSM-IV-TR®)1,2
  • Primary Endpoint: Change from baseline to endpoint in ADHD-RS-IV total score*1,2
  • Key Secondary Endpoint: Duration of efficacy as measured by CPRS ADHD index at 10 am, 2 pm, and 6 pm1
  • 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.
  • ADHD-RS-IV=Attention-Deficit/Hyperactivity Disorder Rating Scale, Version IV, a validated investigator-rated measure that consists of 18 items designed to reflect symptomatology of ADHD based on DSM-IV-TR® criteria.
  • CPRS=Conners' Parent Rating Scale, an instrument that uses parent ratings to help assess ADHD symptoms and behaviors in children. In this study, parents rated their child’s symptomatic behaviors at 10 am, 2 pm, and 6 pm.
PATIENT CHARACTERISTICS1,2:
  • 290 patients aged 6-12 years
  • Primary diagnosis of ADHD based on DSM-IV-TR® criteria
  • Baseline ADHD-RS-IV total score of ≥28

INDICATION AND LIMITATION OF USE
Vyvanse® (lisdexamfetamine dimesylate) is indicated for the treatment of 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.

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*

Vyvanse provided a 56% average reduction in ADHD-RS-IV total score (from 43.9 to 19.5) for all doses combined vs a 14% average reduction for placebo (from 42.4 to 36.6)*

  • *P<.0001 for Vyvanse versus placebo.

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.
KEY SECONDARY ENDPOINT: Duration of efficacy as measured by CPRS ADHD index1,2

Children aged 6-12 years treated with Vyvanse experienced significant symptom improvement based on CPRS at 10am, 2pm, and 6pm

LS Mean Percentage Change From Baseline to Endpoint on CPRS ADHD Index4-6

  • LS=least squares.
  • *P<.001 for Vyvanse vs placebo at all timepoints assessed.
  • Mean of all doses tested. Median daily dosing between 7:30 am and 8 am.

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