ADVERSE REACTIONS

Safety information
for treating

moderate to severe
B.E.D. with Vyvanse

Hypothetical patient portrayal. Individual results may vary.

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 rates3,4:

  • 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

Help your eligible patients start saving.

Hypothetical patient portrayal

SHOW YOUR ELIGIBLE PATIENTS HOW THEY COULD SAVE

We’re dedicated to providing a savings offer to help make Vyvanse prescriptions accessible to your eligible patients. See details. Restrictions apply.

Guide patients to their appropriate dose.

Hypothetical patient portrayal.
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

Hypothetical patient portrayal

KEEP IN TOUCH

Stay up to date with the latest information to help support your Vyvanse patients.

References
  1. Vyvanse [package insert]. Lexington, MA: Shire US Inc.
  2. Data on file; SPD489-169; Shire US Inc.
  3. 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.
  4. Data on file; SPD489-212; Shire US Inc.

INDICATION AND IMPORTANT SAFETY INFORMATION