Vyvanse is a prescription medicine used for the
treatment of moderate to severe binge eating
disorder (B.E.D.) in adults. Vyvanse is not for
weight loss. It is not known if Vyvanse is safe
and effective for the treatment of obesity.
Binge eating
disorder is
something I have,
not something
I do.
Jamie R.
Diagnosed with moderate B.E.D.
WHAT’S NEW?
See the latest,
longer-term data (38 weeks)
on pg. 9
IMPORTANT SAFETY INFORMATION
Vyvanse® is a federally controlled substance (CII)
because it can be abused or lead to dependence.
Keep Vyvanse in a safe place to prevent misuse
and abuse. Selling or giving away Vyvanse may
harm others and is against the law.
Vyvanse is a stimulant medicine. Tell the doctor if
you have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
For additional safety information, click here for
Prescribing Information and Medication Guide
and discuss with your doctor.
Binge Eating Disorder:
A Real Medical Condition
Binge eating disorder (B.E.D.) is the most common
eating disorder in US adults—more than anorexia
and bulimia combined.* Increased understanding of
this disorder has resulted in B.E.D. being recognized
as a distinct medical condition. Only a doctor or other
trained health care professional can diagnose B.E.D. and
determine an appropriate treatment plan. Medicine may
not be appropriate for all adults with B.E.D. Talk to your
doctor to see what might be right for you.
B.E.D. vs Overeating
While overeating is a challenge for many Americans,
repeated binge eating is much less common and
far more severe.
In US adults, B.E.D. occurs in both
men and women, and across
different races and ethnicities†
Average Age of Onset
On average, the onset of B.E.D. in adults appears
at a later age compared to bulimia and anorexia.*
The Majority of Adults with Binge
Eating Disorder Are Not Obese*
B.E.D. can occur in normal-weight, overweight,
or obese adults.*
45%
55%
ARE OBESE
ARE NORMAL-WEIGHT
OR OVERWEIGHT
Of these, 19% are normalweight (BMI 18.5-24.9) and 36%
are overweight (BMI 25-29.9)
(BMI greater than
or equal to 30)
BMI=body mass index
Based on a sample of 2,980 adults aged ≥18 years who were assessed
for an eating disorder in a national survey.
*
Damien C.
Diagnosed with severe B.E.D.
Sample from combined data set of 3 nationally representative samples
of US adults [non-Latino whites, Latinos, Asians, and African Americans].
†
3
The Symptoms of B.E.D.
The Levels of Severity of B.E.D.
All of the following symptoms must be present in
order for your doctor to make a diagnosis of B.E.D.:
When evaluating for B.E.D., a doctor or other trained
health care professional will consider the diagnostic
criteria described to the left, the number of bingeeating episodes per week, and other factors. A diagnosis
of B.E.D. can be described as mild, moderate, severe, or
extreme.
• Regularly eating far more food than most people
would in a similar time period under similar
circumstances.
• Feeling a loss of control over your eating during
a binge or over how much you are eating.
• When binge eating you experience three or more
of these:
› Eating extremely fast.
› Eating beyond feeling full.
› Eating large amounts of food when not hungry.
› Eating alone to hide how much one is eating.
› Feeling terrible after a binge.
• Feeling very upset by eating binges.
• Have been binge eating, on average, at least once
a week for three months.
• Unlike people with other eating disorders, adults
with B.E.D. don’t routinely try to “undo” their
excessive eating with extreme actions like throwing
up or over-exercising. Binge eating disorder is not
part of another eating disorder.
Mild: 1–3 binge-eating episodes per week.
Moderate: 4–7 binge-eating episodes per week.
Severe: 8–13 binge-eating episodes per week.
Extreme: 14 or more binge-eating episodes per week.
The B.E.D. criteria above are for informational
purposes only and are not intended to make a
diagnosis. Remember, only a doctor or other trained
health care professional can make a diagnosis of
binge eating disorder.
To learn more about binge eating disorder
visit VyvanseBED.com
Allegra D.
Diagnosed with
severe B.E.D.
5
Vyvanse is a prescription medicine used for the treatment of
moderate to severe binge eating disorder (B.E.D.) in adults.
Vyvanse is not for weight loss. It is not known if Vyvanse is
safe and effective for the treatment of obesity.
See How Vyvanse Performed
in Short-Term Studies
In two 12-week studies of adults who were diagnosed with
moderate to severe binge eating disorder (B.E.D.), Vyvanse
was proven to reduce weekly binge days (a day with at least
1 binge episode).
At the end of both Study 1 and Study 2, adults with
moderate to severe B.E.D. who took Vyvanse experienced,
on average, significantly fewer binge days per week
compared to those who took placebo. The change
in binge days per week for adult patients with moderate
to severe B.E.D. from the start of the study to the end was
measured using a statistical measure called the LS-Mean.
Important Information About Vyvanse
Vyvanse is a stimulant medicine. Tell the doctor if
you have ever abused or been dependent on alcohol,
prescription medicines, or street drugs.
You Should Not Take Vyvanse if You:
• are taking or have taken an anti-depression medicine
called a monoamine oxidase inhibitor (MAOI) within
the past 14 days.
• are sensitive to, allergic to, or had a reaction to other
stimulant medicines.
The results from each study at Week 12:
More From the Short-Term Studies
• At the end of Study 1, on average, Vyvanse decreased
binge days per week by 1.35 days more than placebo
(from the start of the study) — that is an average
decrease of 3.87 days for Vyvanse and 2.51 days for
placebo.
• At the end of Study 2, on average, Vyvanse decreased
binge days per week by 1.66 days more than placebo
(from the start of the study) — that is an average
decrease of 3.92 days for Vyvanse and 2.26 days for
placebo.
In the same studies, a tool used by a doctor that measures
obsessive binge eating thoughts and compulsive binge
eating behaviors related to B.E.D.— the Yale-Brown
Obsessive Compulsive Scale Modified for Binge Eating,
or Y-BOCS-BE— was used. At the final visit of each of
the 12-week studies, patients taking Vyvanse had a
greater decrease in obsessive and compulsive thoughts
and behaviors about binge eating compared to patients
taking placebo.
IMPORTANT SAFETY INFORMATION
Who should not take Vyvanse?
Do not take Vyvanse if you are:
•taking or have taken an anti-depression medicine
called a monoamine oxidase inhibitor (MAOI) within
the past 14 days.
•sensitive or allergic to, or had a reaction to other
stimulant medicines.
For additional safety information, click here for
Prescribing Information and Medication Guide
and discuss with your doctor.
Problems that can occur while taking Vyvanse.
Tell the doctor:
• if you have heart problems or heart defects, high
blood pressure, or a family history of these problems.
This is important because sudden death has occurred
in people with heart problems or defects taking
stimulant medicines, and sudden death, stroke and
heart attack have happened in adults taking stimulant
medicines. Since increases in blood pressure and heart
rate may occur, the doctor should regularly check these
during treatment. Call the doctor right away if you
have any signs of heart problems such as chest pain,
shortness of breath, or fainting while taking Vyvanse. 7
Vyvanse is a prescription medicine used for the treatment of
moderate to severe binge eating disorder (B.E.D.) in adults.
Vyvanse is not for weight loss. It is not known if Vyvanse is
safe and effective for the treatment of obesity.
More From the Short-Term Studies (cont.)
Doctors’ Rating of Improvement
In the two studies, doctors also rated patients as much
improved or very much improved (“improved”), or not
improved, using the Clinical Global ImpressionsImprovement rating scale. In Study 1, of patients treated
with Vyvanse, 82% were rated “improved” and 18% rated
“not improved.” Of patients treated with placebo, 47%
were rated “improved” and 53% rated “not improved.” In
Study 2, of patients treated with Vyvanse, 86% were rated
“improved” and 14% rated “not improved.” Of patients
treated with placebo, 43% were rated “improved” and
57% were rated “not improved.”
4-Week Time Period with No
Binge-Eating Episodes
Need Help Controlling Your Moderate
or Severe B.E.D. Symptoms?
New research has shown that Vyvanse was
effective at controlling B.E.D. symptoms
throughout the course of a new longer-term
study of 38 weeks. In the study, patients who initially
responded to Vyvanse had a longer time to relapse*
compared to those who were switched to placebo.
Adverse events seen in this study were consistent
with those seen in other studies of adult patients
with moderate to severe B.E.D. on Vyvanse.
Relapse was defined as a worsening in both the
number of binge eating days (2 or more per week
for 2 consecutive weeks) and the illness severity
score determined by the health care professional.
*
In the two clinical studies, the percentage of patients who
had no binge-eating episodes in the last 4 weeks of the
studies was measured. This was defined as a patient who
experienced no binge-eating episodes during the 4 weeks
leading up to the patient’s last visit of the study. In both
studies, patients taking Vyvanse were more likely to have
no binge-eating episodes during this 4-week time period
compared to patients taking placebo.
IMPORTANT SAFETY INFORMATION CONT.
Problems that can occur while taking Vyvanse.
Tell the doctor:
• if you have mental problems, or a family history of
suicide, bipolar illness, or depression. This is important
because new or worsening behavior and thought
problems or bipolar illness may occur. New symptoms
such as seeing or hearing things that are not real,
believing things that are not true, being suspicious,
or having new manic symptoms may occur. Call the
doctor right away if there are any new or worsening
mental symptoms during treatment.
Problems that can occur while taking Vyvanse.
Tell the doctor:
• if you have circulation problems in fingers and
toes (peripheral vasculopathy, including Raynaud’s
phenomenon). Fingers or toes may feel numb, cool,
painful, sensitive to temperature and/or change color
from pale, to blue, to red. Call the doctor right away
if any signs of unexplained wounds appear on fingers
or toes while taking Vyvanse.
For additional safety information, click here for
Prescribing Information and Medication Guide
and discuss with your doctor.
9
Vyvanse is a prescription medicine used for the treatment of
moderate to severe binge eating disorder (B.E.D.) in adults.
Vyvanse is not for weight loss. It is not known if Vyvanse is
safe and effective for the treatment of obesity.
Problems May Occur While
Taking Vyvanse
Getting Started with Vyvanse
Vyvanse is a once-a-day capsule that should be taken
in the morning, with or without food, exactly as your
doctor tells you to take it.
In clinical studies, adult patients with moderate to severe
B.E.D. began treatment with 30 mg per day, and by week
4 were treated with 50 mg or a maximum dose of 70 mg
per day. Your own treatment needs may be different. It is
important to work with your doctor to find the dose that
is right for you.
RECOMMENDED ONCE-DAILY DOSING
MAXIMUM DOSE
30mg
STARTING
DOSE
50mg
70mg
TARGET DOSE RANGE
Tell the Doctor If You:
•h
ave kidney problems. Your doctor may lower your
dose.
Tell the doctor if you:
• have heart problems or heart defects, high blood
pressure, or a family history of these problems. This
is important because sudden death has occurred in
people with heart problems or defects taking stimulant
medicines, and sudden death, stroke, and heart attack
have happened in adults taking stimulant medicines.
Since increases in blood pressure and heart rate may
occur, the doctor should regularly check these during
treatment. Call the doctor right away if you have any
signs of heart problems such as chest pain, shortness
of breath, or fainting while taking Vyvanse.
• have mental problems, or a family history of suicide,
bipolar illness, or depression. This is important because
new or worsening behavior and thought problems or
bipolar illness may occur. New symptoms such as seeing
or hearing things that are not real, believing things that
are not true, being suspicious, or having new manic
symptoms may occur. Call the doctor right away if
there are any new or worsening mental symptoms
during treatment.
• have circulation problems in fingers and toes (peripheral
vasculopathy, including Raynaud’s phenomenon).
Fingers or toes may feel numb, cool, painful, sensitive
to temperature and/or change color from pale, to blue,
to red. Call the doctor right away if any signs of
unexplained wounds appear on fingers or toes
while taking Vyvanse.
IMPORTANT SAFETY INFORMATION CONT.
Problems that can occur while taking Vyvanse.
Tell the doctor:
• if you are pregnant or plan to become pregnant. It is
not known if Vyvanse may harm your unborn baby.
For additional safety information, click here for
Prescribing Information and Medication Guide
and discuss with your doctor.
Problems that can occur while taking Vyvanse.
Tell the doctor:
• if you are breastfeeding or plan to breastfeed. Do not
breastfeed while taking Vyvanse. Talk to your doctor
about the best way to feed your baby if you take
Vyvanse.
11
Vyvanse is a prescription medicine used for the treatment of
moderate to severe binge eating disorder (B.E.D.) in adults.
Vyvanse is not for weight loss. It is not known if Vyvanse is
safe and effective for the treatment of obesity.
Talking with Your Doctor
Most Common Side Effects
If you have any concerns, be sure to talk to your doctor.
Only a doctor or other trained health care professional
can diagnose B.E.D. and determine an appropriate
treatment plan.
The most common side effects reported in studies of
adults with moderate to severe B.E.D. taking Vyvanse
were dry mouth, trouble sleeping, decreased appetite,
increased heart rate, constipation, feeling jittery, and
anxiety.
When talking with your doctor about your binge-eating
episodes, it is important to describe your experiences.
It may help to use language your doctor is already familiar
with, found on page 4 of this brochure.
Be sure to give your doctor the most complete and most
accurate information you can so that he or she can do
what is best for you.
Please see important safety information throughout this
brochure. Be sure to talk to your doctor about any side
effects that are bothersome or do not go away. These
are not all the possible side effects of Vyvanse. For more
information ask your doctor or pharmacist.
Vyvanse is not right for all adults with moderate to severe
B.E.D., so be open and direct with your doctor. Share
how long you have experienced episodes of binge eating,
in addition to other details about your binges. Your
health, including your eating habits, is certainly worth
discussing with your doctor.
How Vyvanse May Work
Vyvanse is a stimulant medicine. It is not known exactly
how stimulant medicines work, but they are thought to
increase the level of certain naturally occurring chemicals
in the brain.
Wendy W.
Diagnosed with
moderate B.E.D.
Important to Know
Vyvanse is not for weight loss. It is not known if Vyvanse
is safe and effective for the treatment of obesity.
IMPORTANT SAFETY INFORMATION CONT.
What are possible side effects of Vyvanse?
The most common side effects of Vyvanse reported in
studies of adults with moderate to severe B.E.D. include:
• dry mouth
• constipation
• trouble sleeping
• feeling jittery
• decreased appetite • anxiety
• increased heart rate
For additional safety information, click here for
Prescribing Information and Medication Guide
and discuss with your doctor.
13
Start the Conversation
If you are concerned enough about B.E.D. to talk with
your doctor, then you may have a lot of questions. Write
them down in advance, and take your questions with you
to your next appointment. When it comes to your health,
it is important to address your concerns with your doctor.
E
For additional safety information, click here for
Prescribing Information and Medication Guide
and discuss with your doctor.
15
15
Talk with your doctor today to see
if once-daily Vyvanse is right for you.
IMPORTANT SAFETY INFORMATION
Vyvanse® is a federally controlled substance (CII)
because it can be abused or lead to dependence.
Keep Vyvanse in a safe place to prevent misuse
and abuse. Selling or giving away Vyvanse may
harm others and is against the law.
For additional safety information, click here
for Prescribing Information and Medication Guide
and discuss with your doctor.
You are encouraged to report negative side
effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Sign up for a Vyvanse Savings Offer
at VyvanseBED.com
1-800-828-2088
©2016 Shire US Inc., Lexington, MA 02421
Vyvanse® is a registered trademark of Shire LLC.
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