DIARRHEA AND ABDOMINAL PAIN?

Irritable Bowel Syndrome with Diarrhea (IBS-D)
LIVING WITH FREQUENT
DIARRHEA AND ABDOMINAL PAIN?
VIBERZI may help
VIBERZI is a prescription medicine used to treat
adults who have IBS-D.
Important Risk Information
VIBERZI can cause serious side effects, including:
•A spasm in a muscle of the digestive system (called the
sphincter of Oddi), which may cause new or worsening
abdominal pain. Your risk of having a spasm is increased if
you do not have a gallbladder. This spasm usually happens
within the first week of treatment and usually goes away
when treatment is stopped.
Stop taking VIBERZI and call your doctor if you have new or
worsening stomach-area (abdomen) pain or pain in the upper
right side of your stomach-area (abdomen) that may move to
your back or shoulder, with or without nausea and vomiting.
Please see Important Risk Information
throughout and brief summary
of Medication Guide.
Living with IBS-D
IBS-D is not the same as an occasional stomach issue.
It is a condition that is long-lasting (chronic), that
includes frequent episodes of diarrhea as the most
common symptom, along with abdominal pain.
If you’re living with IBS-D, you know how unpredictable
symptoms like diarrhea and abdominal pain can be.
People with IBS-D can also experience gassiness
and bloating.
IBS-D may be more common than you think
The causes of IBS-D
While food or stress can often trigger IBS-D symptoms,
there’s more to the story. The exact causes of IBS-D
are unclear, but experts believe that a few factors may
be involved:
1
Muscles in the GI tract may
contract too much
2
Nerves in the bowel may not
respond as they should
3
Signals communicating between the
bowel and the brain may be disrupted
Symptoms like frequent diarrhea and abdominal pain
are uncomfortable, bothersome, and frustrating.
Even when they aren’t present, you never know when
they might come back.
Doctor Discussions
Do you ever feel frustrated that your symptoms
keep coming back? Be sure to talk to your doctor
about all your symptoms and the ways you’ve tried
to get ahead of diarrhea and abdominal pain.
2
3
VIBERZI may help
VIBERZI is a prescription medicine for adults with IBS-D
that is taken every day. VIBERZI is specifically designed
for IBS-D. Taking VIBERZI helps you proactively manage
2 of the most bothersome symptoms of IBS-D—diarrhea
and abdominal pain.
VIBERZI may help you feel more in
control of IBS-D symptoms
Taken every day, as prescribed by your doctor, VIBERZI
may provide continued symptom relief. VIBERZI makes
stools less loose and watery and has been shown to
reduce abdominal pain.
Who should not take VIBERZI?
Do not take VIBERZI if you:
•H
ave or had a blockage in your gallbladder or
a sphincter of Oddi problem
•H
ave or had problems with alcohol abuse, alcohol
addiction, or drink more than 3 alcoholic drinks a day
•H
ave had inflammation of your pancreas (pancreatitis)
or other pancreas problems, including if you have had
or may have had a blockage in your pancreas
• Have severe liver problems
•H
ave had long-lasting (chronic) or severe constipation,
or problems caused by constipation
•H
ave or may have had a bowel blockage
(intestinal obstruction)
Talk to your doctor if you are not sure if you have
any of these conditions.
Important Risk Information (cont.)
VIBERZI can cause serious side effects, including:
•Inflammation of the pancreas (called pancreatitis).
Symptoms of pancreatitis usually go away when
treatment with VIBERZI is stopped. Your risk of
getting pancreatitis is increased if you drink more
than 3 alcoholic drinks a day. Limit your use of
alcoholic drinks while you are taking VIBERZI.
top taking VIBERZI and call your doctor if you have
S
new or worsening stomach-area (abdomen) pain or
pain in the upper right side of your stomach-area
(abdomen) that may move to your back or shoulder,
with or without nausea and vomiting.
4
VIBERZI has been shown to relieve the 2 main
symptoms of IBS-D at the same time:
1
2
Reduces
diarrhea
Reduces
abdominal pain
VIBERZI may help you get ahead of diarrhea and
abdominal pain. In clinical trials, VIBERZI helped people
get IBS-D symptoms under control—and keep them
under control.
Please see Important Risk Information
throughout and brief summary
of Medication Guide.
5
What should I tell my doctor before
taking VIBERZI?
Before taking VIBERZI, tell your doctor about all of your
medical conditions, including if you:
• Do not have a gallbladder
• Have liver problems
•A
re pregnant or plan to become pregnant.
It is not known if VIBERZI will harm your unborn baby
How does VIBERZI work?
VIBERZI is the first and only prescription therapy in a
different class of medicine for IBS-D. VIBERZI acts directly
in the intestine to treat the 2 main symptoms of IBS-D.*
Slows the
movement
of food
through the
colon
Reduces
nerve
sensitivity
in the
intestine
•A
re breastfeeding or plan to breastfeed. It is not
known if VIBERZI passes into your breast milk
or could harm your baby
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines,
vitamins, and herbal supplements. VIBERZI and other
medicines may affect each other, causing side effects.
If you are taking VIBERZI,
you should not take:
*This was seen in animal studies and the relevance to
humans is not known.
• Medicines that cause constipation, including:
— Lotronex® (alosetron)
— Anticholinergic medicines
— Opioid pain medicines
Ask your doctor or pharmacist for a list of these
medicines if you are not sure.
•Y
ou may take loperamide (ie, Imodium®)
occasionally to treat severe diarrhea, but avoid
long-term use. Stop taking loperamide right away
if you become constipated
Doctor Discussions
Have you ever looked for an everyday way to
manage IBS-D symptoms? If so, be sure to share
it with your doctor.
Trademarks are owned by their respective companies.
6
Please see Important Risk Information
throughout and brief summary
of Medication Guide.
7
Make VIBERZI part of your
everyday routine
VIBERZI is 1 tablet, taken 2 times each day with food.
If your doctor prescribes VIBERZI, get into the habit
of taking 1 tablet in the morning and 1 tablet in the
evening. Taking VIBERZI every day may help you
Doctor Discussions
Are you ever frustrated by unpredictable symptoms
like diarrhea and abdominal pain? Be sure to share
that with your doctor.
proactively manage your symptoms of IBS-D.
1 tablet in the morning
with food
What should I avoid while taking VIBERZI?
1 tablet in the evening
with food
8
• Limit your use of alcoholic drinks while you
are taking VIBERZI
• If you have liver problems, do not drive, operate
machinery, or do other dangerous activities until
you know how VIBERZI affects you
Stay with it
What are the possible side effects of VIBERZI?
It’s important to take VIBERZI every day as your
doctor prescribes. Take VIBERZI as long as your doctor
recommends to continue receiving the benefits of
treatment. Keep in mind that IBS-D symptoms may
return if you stop taking VIBERZI.
The most common side effects of VIBERZI include
constipation, nausea, and abdominal pain. Stop
taking VIBERZI and call your doctor if you have
constipation that lasts more than 4 days. These are
not all the possible side effects of VIBERZI. Call your
doctor for medical advice about side effects.
Please see Important Risk Information
throughout and brief summary
of Medication Guide.
9
Frequently asked questions
Q: Will I experience constipation
with VIBERZI?
?? ?
In clinical studies, constipation occurred
in 8% of people taking VIBERZI. Severe
constipation occurred in fewer than 1% of
people. Stop taking VIBERZI and call your
doctor if you have constipation that lasts
more than 4 days.
Q: In what types of people was
VIBERZI studied?
VIBERZI was studied in 2 clinical trials involving
more than 2400 men and women, ages 18 to 80.
Q: Can VIBERZI be used in children
or the elderly?
It is not known if VIBERZI is safe and effective
in children. VIBERZI is a prescription medicine
used to treat adults who have IBS-D.
Patients aged 65 years and older were included
in the clinical trials. No overall differences in
effectiveness were observed between adults
aged 65 years and older and younger people.
People aged 65 years and older had an
increased number of side effects, including
serious side effects and stomach problems,
compared to people younger than age 65.
10
Q: Can I take Imodium® (loperamide)
with VIBERZI?
Always talk to your doctor about other medicines
you might be taking. In clinical studies, people
could take Imodium® as needed while also taking
VIBERZI. If you are taking VIBERZI, you may take
Imodium® occasionally to treat severe diarrhea, but
avoid long-term use. Stop taking Imodium® right
away if you become constipated.
Trademarks are owned by their respective companies.
Q: How is VIBERZI different from
other medicines, like Imodium®
or Pepto-Bismol™?
Imodium® and Pepto-Bismol™ are over-thecounter medicines for occasional use. VIBERZI
is a prescription medicine that is FDA-approved
for daily use in adults with IBS-D to reduce
abdominal pain and diarrhea at the same time.
Trademarks are owned by their respective companies.
Q: What does it mean that VIBERZI is
a controlled substance?
VIBERZI is a federally controlled substance
because it may be abused or lead to
dependence. It has been designated
as a substance which has a low
potential for abuse and a low risk
of dependence.
11
If you’re experiencing symptoms,
talk with your doctor.
It’s important that you talk about all your symptoms
and how long you’ve been experiencing them, so your
doctor can determine if VIBERZI is right for you.
1. Do you have loose or watery stools?
YES
NO
CONSTIPATION
NORMAL
DIARRHEA
Help your doctor by referring to this stool form chart.
Circle the description that is most like what you’re experiencing.
7
Watery, no solid pieces (entirely liquid)
6
Fluffy pieces with ragged edges, a mushy stool
5
Soft blobs with clear-cut edges (passed easily)
4
Like a sausage or snake, smooth and soft
3
Like a sausage but with cracks on surface
2
Sausage-shaped but lumpy
1
Separate hard lumps like nuts (difficult to pass)
© 2006 The Rome Foundation, Inc.
2. H
ow many times per week do you have
loose or watery stools?
3. D
o you experience abdominal (stomach) pain? YES
NO
4. Have you had the symptoms above for
at least 3 months or more?
YES
NO
5. Do your symptoms keep coming back?
YES
NO
Please see Important Risk Information
throughout and brief summary
of Medication Guide.
Allergan® and its design are trademarks of Allergan, Inc.
VIBERZI™ and its design are trademarks of Furiex Pharmaceuticals, LLC, an Allergan affiliate.
© 2016 Allergan. All rights reserved. VBZ50022 03/16
Brief Summary of
the Medication Guide
VIBERZI (vye BER zee), CIV
(eluxadoline) tablets
This information does not take the
place of talking with your doctor
about your medical condition or your treatment.
What is VIBERZI?
VIBERZI is a prescription medicine used to treat adults who
have irritable bowel syndrome with diarrhea (IBS-D).
• VIBERZI is a controlled substance (CIV) because it contains
eluxadoline that can be a target for people who abuse
prescription medicines or street drugs. Keep your VIBERZI
in a safe place to protect it from theft. Never give your
VIBERZI to anyone else, because it may harm them.
Selling or giving away this medicine is against the law.
It is not known if VIBERZI is safe and effective in children.
People 65 years old and older have had an increased number
of side effects, including serious side effects and stomach
problems, while taking VIBERZI than people younger than
65 years old have had.
What is the most important information I should know
about VIBERZI?
VIBERZI can cause serious side effects, including:
•Sphincter of Oddi spasm. A spasm in a muscular valve of the
digestive system (called the sphincter of Oddi), which may
cause new or worsening stomach area (abdomen) pain.
Your risk of having a spasm is increased if you do not have
a gallbladder. This spasm usually happens within the first
week of treatment with VIBERZI and usually goes away when
treatment with VIBERZI is stopped.
•Inflammation of the pancreas (pancreatitis). Symptoms of
pancreatitis usually go away when treatment with VIBERZI is
stopped. Your risk of getting pancreatitis is increased if you
drink more than 3 alcoholic drinks a day. Limit your use of
alcoholic drinks while you are taking VIBERZI.
Stop taking VIBERZI and call your doctor if you have new or
worsening stomach-area (abdomen) pain or pain in the upper
right side of your stomach-area (abdomen) that may move to
your back or shoulder, with or without nausea and vomiting.
Who should not take VIBERZI?
Do not take VIBERZI if you:
•have or may have had a blockage in your gallbladder or a
sphincter of Oddi problem
• have or had problems with alcohol abuse, alcohol addiction,
or drink more than 3 alcoholic drinks a day
•have had inflammation of your pancreas (pancreatitis)
or other pancreas problems, including if you have had or
may have had a blockage in your pancreas
•have severe liver problems
•have had long-lasting (chronic) or severe constipation,
or problems caused by constipation
•have or may have had a bowel blockage
(intestinal obstruction)
Talk to your doctor if you are not sure if you have any of these
conditions.
What should I tell my doctor before taking VIBERZI?
Before taking VIBERZI, tell your doctor about all of your
medical conditions, including if you:
• do not have a gallbladder
• have liver problems
• are pregnant or plan to become pregnant. It is not known
if VIBERZI will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if
VIBERZI passes into your breast milk or could harm your baby.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and
herbal supplements. Keep a list of your medicines to show your
doctor and pharmacist when you get a new medicine. VIBERZI
and other medicines may affect each other causing side effects.
If you are taking VIBERZI you should not take:
• medicines that cause constipation including:
o Lotronex® (alosetron)
o anticholinergic medicines
o opioid pain medicines
Ask your doctor or pharmacist for a list of these medicines,
if you are not sure.
• Avoid taking loperamide, a medicine used to treat diarrhea,
for a long time (chronic use). You may take loperamide
occasionally to treat severe diarrhea. Stop taking loperamide
right away if you become constipated.
How should I take VIBERZI?
•Take VIBERZI exactly as your doctor tells you to take it.
•Take 1 tablet of VIBERZI 2 times each day with food.
• If you miss a dose, take your next dose at your regular time.
Do not take 2 doses at the same time to make up for a
missed dose.
•Do not change your dose or stop taking VIBERZI unless your
doctor tells you to.
• If you take too much VIBERZI, call your doctor or go to
the nearest hospital emergency room right away.
What should I avoid while taking VIBERZI?
• Limit your use of alcoholic drinks while you are taking VIBERZI.
• If you have liver problems, do not drive, operate machinery,
or do other dangerous activities until you know how VIBERZI
affects you.
What are the possible side effects of VIBERZI?
The most common side effects of VIBERZI include:
constipation, nausea, and abdominal pain. Stop taking VIBERZI
and call your doctor if you have constipation that lasts more
than 4 days.
These are not all the possible side effects of VIBERZI.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
Keep VIBERZI and all medicines out of the reach of children.
Need more information?
• This section summarizes the most important information
about VIBERZI. If you would like more information, talk with
your doctor.
• Go to www.VIBERZI.com or call 1-800-272-5525
VIBERZITM and its design are trademarks of
Furiex Pharmaceuticals, LLC, an Allergan affiliate.
Distributed by: Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
© Actavis 2015. All rights reserved.
ELX38198 10/15