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

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
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.

DOSING

Titrate to target dose to treat moderate to severe B.E.D. IN ADULTS¹

Start with 30 mg per day, the recommended Vyvanse starting dose¹

Convenient, once-daily dosing¹

Recommended dosing titration¹

Dose distribution during the 8-week dose-maintenance period of Study 343^*2,3

DOSING SAFETY INFORMATION

KEEP IN TOUCH

References

INDICATION AND IMPORTANT SAFETY INFORMATION

DOSING

Titrate to target dose to treat moderate to severe B.E.D. IN ADULTS1

Start with 30 mg per day, the recommended Vyvanse starting dose1

Convenient, once-daily dosing1

Recommended dosing titration1

Dose distribution during the 8-week dose-maintenance period of Study 343*2,3

DOSING SAFETY INFORMATION

KEEP IN TOUCH

References

INDICATION AND IMPORTANT SAFETY INFORMATION

Titrate to target dose to treat moderate to severe B.E.D. IN ADULTS¹

Start with 30 mg per day, the recommended Vyvanse starting dose¹

Convenient, once-daily dosing¹

Recommended dosing titration¹

Dose distribution during the 8-week dose-maintenance period of Study 343^*2,3