This site is intended for US health care professionals only.

IMPORTANT SAFETY INFORMATION

This site is intended for US healthcare 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 and monitor for signs of abuse and dependence while on therapy.

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.

Adverse Reactions in Adults With Moderate to Severe B.E.D. Taking Vyvanse^®

Studies 1 and 2

Adverse reactions reported by ≥5% 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 Reaction Vyvanse (n=373) Placebo (n=372)

Dry mouth36% 7%

Insomnia*20% 8%

Decreased appetiteDecreased
appetite8% 2%

Increased heart rate^†Increased heart
rate^†7% 1%

Feeling jittery6% 1%

Constipation6% 1%

Anxiety5% 1%

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

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

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 rate of placebo) included increased heart rate, headache, abdominal pain upper, dyspnea, rash, insomnia, irritability, feeling jittery and anxiety

Longer-Term (6 Months) 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.¹

Open-Label Treatment Phase (12 weeks)¹

Adverse Reaction	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)¹

Adverse Reaction	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 previously been reported in adults.²

Discontinuation Rates^2,3:

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 led to discontinuation in ≥1% of Vyvanse-treated patients

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 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 children and adolescents 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 with ADHD (monitor weight and height). Treatment may need to be interrupted in children not growing or gaining weight 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 during treatment for new numbness, pain, skin color change, or sensitivity to temperature in fingers and toes. 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.

Please click here for Full Prescribing Information.

References

Vyvanse [package insert]. Lexington, MA: Shire US Inc.
Data on file; SPD489-169; Shire US Inc.

References

Hudson J, McElroy S, Ferreira-Cornwell MC, Radewonuak J, Gasior M. A double-blind, placebo-controlled, randomized-withdrawal study of lisdexamfetamine dimesylate in adults with moderate to severe binge eating disorder. Paper presented at: 54th Annual Meeting of the American College of Neuropsychopharmacology; December 6-10, 2015; Hollywood, FL.
Data on file. SPD489-212; Shire US Inc.
Vyvanse [package insert]. Lexington, MA: Shire US Inc.

Adverse Reactions in Adults With Moderate to Severe B.E.D. Taking Vyvanse®

Studies 1 and 2

Discontinuation rates1:

Longer-Term (6 Months) Maintenance of Efficacy Study

Open-Label Treatment Phase (12 weeks)1

Randomized-Withdrawal Phase (26 weeks)1

Discontinuation Rates2,3:

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Adverse Reactions in Adults With Moderate to Severe B.E.D. Taking Vyvanse^®

Discontinuation rates¹:

Open-Label Treatment Phase (12 weeks)¹

Randomized-Withdrawal Phase (26 weeks)¹

Discontinuation Rates^2,3: