ADVERSE REACTIONS

ADVERSE REACTIONS ADULT & PEDIATRIC STUDIES IN ADHD

Hypothetical patient portrayal. Individual results may vary.

ADVERSE REACTIONS

SAFETY PROFILE

STUDY 303

IN ADULTS

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

ADVERSE REACTIONS VYVANSE
(n=358)
PLACEBO
(n=62)
Decreased Appetite 27% 2%
Insomnia 27% 8%
Dry Mouth 26% 3%
Diarrhea 7% 0%
Nausea 7% 0%
Anxiety 6% 0%
Anorexia 5% 0%
Feeling Jittery 4% 0%
Agitation 3% 0%
Increased Blood Pressure 3% 0%
Hyperhidrosis 3% 0%
Restlessness 3% 0%
Decreased Weight 3% 0%
Dyspnea 2% 0%
Increased Heart Rate 2% 0%
Tremor 2% 0%
Palpitations 2% 0%

Discontinuation Rates in Adults1

Six percent (21/358) of Vyvanse-treated adult patients discontinued due to adverse reactions compared to 2% (1/62) of placebo-treated patients.

The most frequently reported adverse reactions (1% or more and twice the rate 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%). Less frequently reported adverse reactions (less than 1% or less than twice the rate of placebo) included palpitations, diarrhea, nausea, decreased appetite, dizziness, agitation, depression, paranoia, and restlessness.

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.

STUDY 301

IN CHILDREN

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 Study 301, the 4-week, parallel-group, pivotal clinical study (N=290).1

ADVERSE REACTIONS VYVANSE
(n=218)
PLACEBO
(n=72)
Decreased Appetite 39% 4%
Insomnia 22% 3%
Upper Abdominal Pain 12% 6%
Irritability 10% 0%
Vomiting 9% 4%
Decreased Weight 9% 1%
Nausea 6% 3%
Dry Mouth 5% 0%
Dizziness 5% 0%
Affect Lability 3% 0%
Rash 3% 0%
Pyrexia 2% 1%
Somnolence 2% 1%
Tic 2% 0%
Anorexia 2% 0%

Discontinuation Rates in Children (aged 6-12)1

Eight percent (18/218) of Vyvanse-treated pediatric 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 the 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, ie, 2/218 [1%]). Less frequently reported adverse reactions (less than 1% or less than twice the rate of placebo) included upper abdominal pain, dry mouth, decreased weight, dizziness, somnolence, logorrhea, chest pain, anger, and hypertension.

STUDY 305

IN ADOLESCENTS

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 Study 305, the 4-week, parallel-group, pivotal clinical study (N=310).1

ADVERSE REACTIONS VYVANSE
(n=233)
PLACEBO
(n=77)
Decreased Appetite 34% 3%
Insomnia 13% 4%
Decreased Weight 9% 0%
Dry Mouth 4% 1%
Palpitations 2% 1%
Anorexia 2% 0%
Tremor 2% 0%

Discontinuation Rates in Adolescents (aged 13-17)1

Three percent (7/233) of Vyvanse-treated adolescent 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 the 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 the rate of placebo) included irritability, dermatillomania, mood swings, and dyspnea.


Know your pediatric patients and administration options.

Hypothetical patient portrayal

ONCE-DAILY DOSING AND CUSTOMIZABLE ADMINISTRATION

Vyvanse has once-daily dosing and onlyVyvanse (lisdexamfetamine dimesylate) has 5 administration options, so you can tailor treatment to meet the needs of each patient with ADHD.1

Hypothetical patient portrayal

KEEP IN TOUCH

Stay up to date with the latest information and resources to help support your Vyvanse patients.

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

INDICATION AND IMPORTANT SAFETY INFORMATION