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.
Full Safety Information Below

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
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
Shire

All content of this Web site including text, images, graphics, sound files, and their arrangements, belongs to Shire and is protected by international copyrights 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 online privacy policy for more information. While Shire US Inc. makes reasonable efforts to include accurate, up-to-date information on the site, Shire US Inc. makes no warranties or representations as to its accuracy. Shire US Inc. assumes no liability for any errors or omissions in the content of the site.

AdChoices

S38425  04/18

You are about to leave vyvansepro.com.

Please be advised that Shire has no control over the content or presentation of the site you are about to view.

Cancel Continue