This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US health care 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; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) 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.

Side Effects with Vyvanse

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

Adverse reactions Vyvanse (n=218) Placebo (n=72)
Decreased AppetiteDecreased
Appetite
39% 4%
Insomnia23% 3%
Abdominal Pain Upper12% 6%
Irritability10% 0%
Vomiting9% 4%
Weight Decreased9% 1%
Nausea6% 3%
Dry Mouth5% 0%
Dizziness5% 0%
Affect Lability3% 0%
Rash3% 0%
Pyrexia2% 1%
Somnolence2% 1%
Tic2% 0%

Discontinuation rates1

In the controlled trial in patients aged 6 to 12 years, 9% (20/218) of Vyvanse-treated patients discontinued due to adverse reactions compared with 1% (1/72) of placebo-treated patients. The most frequent adverse reactions leading to discontinuation (i.e., leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were ECG voltage criteria for ventricular hypertrophy, tic, vomiting, psychomotor hyperactivity, insomnia, and rash (2 instances for each adverse reaction, i.e., 2/218 each [1%]).

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

Adverse Reactions Vyvanse (n=233) Placebo (n=77)
Decreased AppetiteDecreased
Appetite
34% 3%
Insomnia13% 4%
Weight Decreased9% 0%
Dry Mouth4% 1%

Discontinuation rates

In the controlled trial in patients ages 13 to 17 years, 4% (10/233) of Vyvanse-treated patients discontinued due to adverse reactions compared to 1% (1/77) of placebo-treated patients. The most frequent adverse reactions leading to discontinuation were irritability (3/233; 1%), decreased appetite (2/233; 1%), and insomnia (2/233; 1%).1

Adverse reactions reported by ≥2% of adult patients taking Vyvanse and at least twice the incidence in patients taking placebo in Study 303, a 4-week, parallel-group, pivotal clinical study (n=420)1

Adverse reactions Vyvanse (n=358) Placebo (n=62)
Decreased AppetiteDecreased
Appetite
27% 2%
Insomnia27% 8%
Dry Mouth26% 3%
Diarrhea7% 0%
Nausea7% 0%
Anxiety6% 0%
Anorexia5% 0%
Feeling Jittery4% 0%
Agitation3% 0%
Increased Blood Pressure3% 0%
Hyperhidrosis3% 0%
Restlessness3% 0%
Decreased Weight3% 0%
Dyspnea2% 0%
Increased Heart Rate2% 0%
Tremor2% 0%

Discontinuation rates1

In the controlled adult trial, 6% (21/358) of Vyvanse-treated patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients. The most frequent adverse reactions leading to discontinuation (ie, leading to discontinuation in at least 1% of Vyvanse-treated patients and at a rate at least twice that of placebo) were insomnia (8/358; 2%), tachycardia (3/358; 1%), irritability (2/358; 1%), hypertension (4/358; 1%), headache (2/358; 1%), anxiety (2/358; 1%), and dyspnea (3/358; 1%).

In the adult population, erectile dysfunction was observed in 2.6% of males who took Vyvanse and 0% who took placebo; decreased libido was observed in 1.4% of subjects who took Vyvanse and 0% who took placebo.1


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; monitor for signs of abuse and dependence during therapy.
  • 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 (MAOI) or have taken an MAOI within the past 14 days. Hypertensive crisis can occur.
  • Warnings and Precautions
    • Prior to and during treatment assess for the presence of cardiac disease. Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, and other serious heart problems. Note that sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in children and adolescents with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can cause increases in blood pressure (mean increase about 2-4 mm Hg) and heart rate (mean increase about 3-6 bpm). Monitor all patients for tachycardia and hypertension.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Monitor weight and height in children during treatment with Vyvanse. Treatment may need to be interrupted in children not growing as expected.
    • CNS stimulants, including Vyvanse, are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; very rare sequelae include digital ulceration and/or soft tissue breakdown. Observe patients for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. Further evaluation may be required, including referral.
  • Adverse Reactions
    The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials were:
    • Children aged 6 to 12: decreased appetite, insomnia, upper abdominal pain, irritability, vomiting, decreased weight, nausea, dry mouth, and dizziness;
    • Adolescents aged 13 to 17: decreased appetite, insomnia, and decreased weight;
    • Adults: decreased appetite, insomnia, dry mouth, diarrhea, nausea, anxiety, and anorexia.
  • Pregnancy and Lactation
    Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.

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.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

Reference

  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.

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