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; monitor for signs of abuse and dependence during therapy.
Full Safety Information Below

Vyvanse® (lisdexamfetamine dimesylate) 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
appetite
8% 2%
Increased heart rateIncreased 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 Rates2,3:

  • 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; monitor for signs of abuse and dependence during therapy.
  • Contraindications

    Patients should not take Vyvanse if they are:

    • hypersensitive to amphetamines or other ingredients of Vyvanse. Anaphylactic reactions, Stevens-Johnson Syndrome, angioedema, and urticaria have occurred.
    • taking 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. Note that 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. Evaluate patients with exertional chest pain, unexplained syncope, or arrhythmias while taking Vyvanse.
    • CNS stimulants can 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.
    • Prior to treatment assess for the presence of bipolar disorder. CNS stimulants may cause psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with pre-existing psychosis.
    • 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 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 (eg, SSRIs, SNRIs, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort), but also during overdosage situations. The potential for a pharmacokinetic interaction exists with co-administration of CYP2D6 inhibitors which may increase the risk with increased exposure to the active metabolite of Vyvanse (dextroamphetamine). In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6. If serotonin syndrome occurs, discontinue Vyvanse and any concomitant serotonergic agents immediately 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, feeling jittery, constipation, 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.

INDICATION AND LIMITATION OF USE

Vyvanse (lisdexamfetamine dimesylate) 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.

Please click here for Full Prescribing Information, including Boxed WARNING regarding Potential for Abuse and Dependence.

References

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

References

  1. 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.
  2. Data on file. SPD489-212; Shire US Inc.
  3. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
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