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

311 Study: Analog Classroom Setting Study

Explore the clinical study design of Vyvanse as a treatment for pediatric patients with ADHDVyvanse demonstrated consistent behavior improvement at each postdose timepoint measured for children aged 6-12 years with ADHD¹

  • Randomized, double-blind, placebo-controlled, crossover, analog-classroom study in 129 children aged 6 to 12 years with ADHD (as defined by DSM-IV-TR®)1
  • During a 4-week open-label, dose-optimization phase, subjects were titrated to an optimal dose of Vyvanse 30, 50, or 70 mg/day in the morning. They were randomized in the double-blind crossover phase to receive Vyvanse (optimized dose) followed by placebo or placebo followed by Vyvanse, each for 1 week of treatment. During the double-blind phase, efficacy assessments occurred at the end of each week in the analog classroom setting using the SKAMP-D subscale1,2
  • Primary Endpoint: Time of onset of Vyvanse compared with placebo in the analog classroom setting, as measured by average SKAMP-D subscale scores2
  • Key Secondary Endpoint: Duration of efficacy of Vyvanse compared with placebo in the analog classroom setting, as measured by average SKAMP-D subscale scores2
    • Evaluated at 1.5, 2.5, 5, 7.5, 10, 12, and 13 hours postdose
  • DSM-IV-TR®=Diagnostic and Statistical Manual of Mental Disorders, 4th ed, text revision.
  • SKAMP-D (Swanson, Kotkin, Agler, M-Flynn, and Pelham Deportment) subscale is a validated, standardized classroom assessment tool that measures behavior problems leading to classroom disruptions. It is not a measure of classroom or academic performance. Lower scores indicate less severe symptoms.
STUDY FLOW1,2

PATIENT CHARACTERISTICS1,2:
  • This study included 129 patients
  • Primary diagnosis of ADHD based on DSM-IV-TR® criteria
STUDY ENVIRONMENT

Schedule for Analog Classroom Sessions and SKAMP-D Assessments (Weeks 5 and 6)2,3

  • Throughout the study, classroom sessions were conducted in which children performed individual and group activities to simulate a classroom setting2
  • An independent observer rated the subject’s degree of behavioral impairment by using a 7-point scale (0=normal, 6=maximal impairment) on each SKAMP-D subscale item2
  • SKAMP-D is not a measure of classroom or academic performance3

Subjects treated with Vyvanse experienced a statistically significant improvement in their SKAMP-D score throughout the day at every postdose timepoint measured vs placebo.1,2

PRIMARY ENDPOINT: SKAMP-D time of onset1,2

Significant improvement in behavior at 1.5 hours postdose based on SKAMP-D

  • At 1.5 hours postdose, SKAMP-D score of .70 for Vyvanse vs. 1.14 for placebo (P<.005)
KEY SECONDARY ENDPOINT: SKAMP-D duration of efficacy1-3

Significant improvement in behavior up to 13 hours at all timepoints measured postdose based on SKAMP-D

LS Mean SKAMP-D Score by Postdose Timepoint1-3

  • n=113.
  • *Average of all doses tested.
  • P<.005 for Vyvanse vs placebo at all postdose timepoints assessed.
  • LS=least squares.

IMPORTANT SAFETY INFORMATION (cont’d)

  • Contraindications
    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking 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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