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

Adverse Reactions for Pediatric Patients

Adverse reactions reported by ≥2% of pediatric patients (6‑12 years of age) taking Vyvanse and at least twice the incidence in patients taking placebo in the 301, 4‑week, parallel-group, pivotal clinical study (n=290).¹

Adverse Reactions in ≥2% of pediatric patients taking Vyvanse¹

Adverse reactions Vyvanse (n=218) Placebo (n=72)
Decreased Appetite39%4%
Insomnia22% 3%
Upper Abdominal Pain12% 6%
Irritability10% 0%
Vomiting9% 4%
Decreased Weight9% 1%
Nausea6% 3%
Dry Mouth5% 0%
Dizziness5% 0%
Affect Lability3% 0%
Rash3% 0%
Pyrexia2% 1%
Somnolence2% 1%
Tic2% 0%
Anorexia2% 0%

Discontinuation rates¹

In this controlled trial in children ages 6 to 12 years, 8% (18/218) of Vyvanse-treated patients discontinued due to adverse reactions compared to 0% (0/72) of placebo-treated patients.

The most frequently reported adverse reactions (1% or more and twice rate of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, decreased appetite and rash [2 instances for each adverse reaction, i.e., 2/218 (1%)]. Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included abdominal pain upper, dry mouth, weight decreased, dizziness, somnolence, logorrhea, chest pain, anger and hypertension.1


Adverse Reactions for Adolescent Patients

Adverse reactions reported by ≥2% of adolescent patients (13‑17 years of age) taking Vyvanse and at least twice the incidence in patients taking placebo in the 305, 4‑week, parallel-group, pivotal clinical study (n=310).¹

Adverse Reactions in ≥2% of adolescent patients taking Vyvanse¹

Adverse reactions Vyvanse (n=233) Placebo (n=77)
Decreased Appetite34%3%
Insomnia13% 4%
Decreased Weight9% 0%
Dry Mouth4% 1%
Palpitations2% 1%
Anorexia2% 0%
Tremor2% 0%

Discontinuation rates¹

In this controlled trial in patients ages 13 to 17 years, 3% (7/233) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The most frequently reported adverse reactions (1% or more and twice rate of placebo) were decreased appetite (2/233; 1%) and insomnia (2/233; 1%). Less frequently reported adverse reactions (less than 1% or less than twice rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.


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