ADVERSE REACTIONS

ADVERSE REACTIONS ADULT & PEDIATRIC STUDIES IN ADHD

Help your patients understand the side effects of treatment.

Hypothetical patient portrayal. Individual results may vary.

ADVERSE REACTIONS

SAFETY PROFILE

In Adults In Children In Adolescents

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.

PROPER USE OF STIMULANT
MEDICATION BROCHURE

Help your patients understand the proper use of stimulant medications for ADHD.

DOWNLOAD BROCHURE

Child drinking orange juice, a mixable option to administer Vyvanse® (lisdexamfetamine dimesylate).

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

ADHD DOSING & ADMINISTRATION

Hypothetical patient portrayal

KEEP IN TOUCH

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

References

Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.

INDICATION AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 and older. Pediatric patients with ADHD younger than 6 years of age experienced more long-term weight loss than patients 6 years and older. 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

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate 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.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with 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.
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. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants 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.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). Treatment may need to be interrupted in patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
- 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. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- 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

Please click here for Full Prescribing Information.

VYVANSE and the VYVANSE logo are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA and the TAKEDA logo are registered trademarks of Takeda Pharmaceutical Company Limited. ©2022 Takeda Pharmaceuticals U.S.A., Inc. All rights reserved. 1-877-TAKEDA-7 (1-877-825-3327).

All content of this website, including text, images, graphics, sound files, and their arrangement, is copyrighted and owned by Takeda Pharmaceuticals U.S.A., Inc. and is protected by international copyright laws. All other intellectual property rights are reserved. The content may not be copied for commercial use or, distribution, nor may these objects be downloaded, modified, or posted to other sites. This site is intended solely for US residents and is governed solely by US laws and government regulations. Please see our Terms of Use for more information. While Takeda makes reasonable efforts to include accurate, up-to-date information on this site, Takeda makes no warranties or representations as to its accuracy. Takeda assumes no liability for any errors or omissions in the content of this site. The information on this site is not intended to make a diagnosis or to take the place of talking to a US healthcare professional.

US-LIS-1285v1.0 10/22

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INDICATION AND LIMITATIONS OF USE

Vyvanse is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in ages 6+. Pediatric patients with ADHD <6 years of age experienced more long-term weight loss than patients 6+ years. It is not for weight loss or to treat obesity. Use of other sympathomimetic drugs for weight loss has been associated with serious cardiovascular adverse events. Click here for FULL SAFETY INFORMATION.

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE: CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate 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. Click here for FULL SAFETY INFORMATION.

INDICATION AND IMPORTANT SAFETY INFORMATION

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INDICATION AND LIMITATIONS OF USE

IMPORTANT SAFETY INFORMATION

WARNING: ABUSE AND DEPENDENCE

CNS stimulants, including Vyvanse, other amphetamine-containing products, and methylphenidate 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.

Contraindications
- Known hypersensitivity to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
- Use with 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.
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. Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulants at recommended doses, as well as sudden death in pediatric patients with structural cardiac abnormalities and other serious heart problems while taking CNS stimulants at recommended doses. Further evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
- CNS stimulants 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.
- Exacerbation of Pre-existing Psychosis: May exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disorder: May induce a mixed/manic episode in patients with bipolar disorder. Prior to initiating treatment, screen for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms, or a family history of suicide, bipolar disorder, and depression). New Psychotic or Manic Symptoms: At recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients with no prior history of psychotic illness or mania. Discontinue if symptoms occur.
- CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients (monitor weight and height). Treatment may need to be interrupted in patients not growing or gaining weight as expected. Vyvanse is not approved for use in pediatric patients below 6 years of age.
- 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. Careful observation for digital changes is necessary during treatment with stimulants. Further evaluation may be required, including referral.
- Increased risk of serotonin syndrome when co-administered with serotonergic agents (e.g., SSRIs, SNRIs, triptans) and CYP2D6 inhibitors, but also during overdosage situations. Discontinue Vyvanse if it occurs and initiate supportive treatment.
Adverse Reactions
- 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.

ADVERSE REACTIONS

ADVERSE REACTIONS ADULT & PEDIATRIC STUDIES IN ADHD

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

Discontinuation Rates in Adults1

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

Discontinuation Rates in Children (aged 6-12)1

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

Discontinuation Rates in Adolescents (aged 13-17)1

PROPER USE OF STIMULANT MEDICATION BROCHURE

ONCE-DAILY DOSING AND CUSTOMIZABLE ADMINISTRATION

KEEP IN TOUCH

References

INDICATION AND IMPORTANT SAFETY INFORMATION

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

Discontinuation Rates in Adults¹

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

Discontinuation Rates in Children (aged 6-12)¹

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

Discontinuation Rates in Adolescents (aged 13-17)¹

PROPER USE OF STIMULANT
MEDICATION BROCHURE