ADVERSE REACTIONS

Safety information
for treating
moderate to severe
B.E.D. with Vyvanse

Help your patients understand potential side effects of treating moderate to severe B.E.D.

Hypothetical patient portrayal. Individual results may vary.

SAFETY DATA

SAFTEY DATA

Two Identically Designed Studies Maintenance of Efficacy Study

STUDIES343 & 344

TWO IDENTICALLY DESIGNED STUDIES

Adverse reactions reported by ≥2% of adult patients with moderate to severe B.E.D. taking Vyvanse and at least twice the incidence in patients taking placebo in 2 identically designed 12-week studies.¹

ADVERSE REACTIONS	VYVANSE (n=373)	PLACEBO (n=372)
Dry Mouth	36%	7%
Insomnia*	20%	8%
Decreased Appetite	8%	2%
Increased Heart Rate^†	7%	1%
Feeling Jittery	6%	1%
Constipation	6%	1%
Anxiety	5%	1%
Diarrhea	4%	2%
Decreased Weight	4%	0%
Hyperhidrosis	4%	0%
Vomiting	2%	1%
Gastroenteritis	2%	1%
Paresthesia	2%	1%
Pruritus	2%	1%
Upper Abdominal Pain	2%	0%
Energy Increased	2%	0%
Urinary Tract Infection	2%	0%
Nightmare	2%	0%
Restlessness	2%	0%
Oropharyngeal Pain	2%	0%

^*Includes all preferred terms containing the word “insomnia.”
^†Includes the preferred terms “heart rate increased” and “tachycardia.”

Discontinuation rates¹:

5.1% (19/373) of Vyvanse-treated patients discontinued due to adverse reactions compared to 2.4% (9/372) of placebo-treated patients
No single adverse reaction led to discontinuation in ≥1% of Vyvanse-treated patients
Less commonly reported adverse reactions (less than 1% or less than twice the rate of placebo) included increased heart rate, headache, upper abdominal pain, dyspnea, rash, insomnia, irritability, feeling jittery, and anxiety

The safety profile of Vyvanse was consistent with what has previously been reported in adults with ADHD.²

STUDY346

MAINTENANCE OF EFFICACY STUDY

Adverse reactions reported by ≥5% of adult patients with moderate to severe B.E.D. taking Vyvanse in a double-blind, placebo-controlled, randomized-withdrawal study.³

Open-label treatment phase (12 weeks)³

ADVERSE REACTIONS	VYVANSE (n=411)
Dry Mouth	33.8%
Headache	16.1%
Insomnia	11.2%
Decreased Appetite	9.2%
Nausea	8.5%
Anxiety	7.1%
Constipation	6.8%
Hyperhidrosis	5.6%
Feeling Jittery	5.1%
Diarrhea	5.1%

Randomized-withdrawal phase (26 weeks)³

ADVERSE REACTIONS	VYVANSE (n=136)	PLACEBO (n=134)
Nasopharyngitis	9.6%	6.7%
Headache	8.8%	6.7%
Upper Respiratory Tract Infection	8.1%	3.7%
Dry Mouth	5.1%	1.5%

The safety profile of Vyvanse was consistent with what has been reported in previous studies of adults with B.E.D.⁴

Discontinuation rates^3,4:

During the open-label phase, 5.4% (22/411) of patients discontinued due to adverse reactions
During the randomized-withdrawal phase, 4.4% (6/136) of Vyvanse-treated patients discontinued due to adverse reactions compared with no placebo patients (0/134)
- -No single adverse reaction was reported for more than 1 patient

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Guide patients to their appropriate dose.

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Individual results may vary.

TITRATE TO THE
TARGET DOSE

Guide your patients through proper titration to the once-daily Vyvanse target dose to help manage their moderate to severe binge eating.¹

Dosing & Titration

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References

Vyvanse [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A., Inc.
Data on file; SPD489-169; Shire US Inc.
Hudson JI, McElroy SL, Ferreira-Cornwell MC, Radewonuk J, Gasior M. Efficacy of lisdexamfetamine in adults with moderate to severe binge-eating disorder: a randomized clinical trial. JAMA Psychiatry. 2017;74(9):903-910.
Data on file; SPD489-212; Shire US Inc.

INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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, 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
- The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Pregnancy and Lactation
Other Considerations
- Safety and effectiveness in patients <18 years with B.E.D. have not been established.

Please click here for Full Prescribing Information.

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US-LIS-1285v1.0 10/22

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INDICATION AND LIMITATION OF USE

Vyvanse is indicated for the treatment of moderate to severe binge eating disorder (B.E.D.) in adults. 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 LIMITATION 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, 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
- The most common adverse reactions (≥5% and at least twice the rate of placebo) reported in clinical trials of adults with moderate to severe B.E.D. were: dry mouth, insomnia, decreased appetite, increased heart rate, constipation, feeling jittery, and anxiety.
Pregnancy and Lactation
Vyvanse may cause fetal harm. Breastfeeding is not recommended during Vyvanse treatment.

Other Considerations
- Safety and effectiveness in patients <18 years with B.E.D. have not been established.

ADVERSE REACTIONS

Safety information for treating moderate to severe B.E.D. with Vyvanse

SAFETY DATA

SAFTEY DATA

STUDIES343 & 344

TWO IDENTICALLY DESIGNED STUDIES

Adverse reactions reported by ≥2% of adult patients with moderate to severe B.E.D. taking Vyvanse and at least twice the incidence in patients taking placebo in 2 identically designed 12-week studies.1

Discontinuation rates1:

STUDY346

MAINTENANCE OF EFFICACY STUDY

Adverse reactions reported by ≥5% of adult patients with moderate to severe B.E.D. taking Vyvanse in a double-blind, placebo-controlled, randomized-withdrawal study.3

Open-label treatment phase (12 weeks)3

Randomized-withdrawal phase (26 weeks)3

Discontinuation rates3,4:

SHOW YOUR ELIGIBLE PATIENTS HOW THEY COULD SAVE

TITRATE TO THE TARGET DOSE

KEEP IN TOUCH

References

INDICATION AND IMPORTANT SAFETY INFORMATION

Safety information
for treating
moderate to severe
B.E.D. with Vyvanse

Adverse reactions reported by ≥2% of adult patients with moderate to severe B.E.D. taking Vyvanse and at least twice the incidence in patients taking placebo in 2 identically designed 12-week studies.¹

Discontinuation rates¹:

Adverse reactions reported by ≥5% of adult patients with moderate to severe B.E.D. taking Vyvanse in a double-blind, placebo-controlled, randomized-withdrawal study.³

Open-label treatment phase (12 weeks)³

Randomized-withdrawal phase (26 weeks)³

Discontinuation rates^3,4:

TITRATE TO THE
TARGET DOSE