- Data illustrates AbbVie's commitment to providing research
and innovative solutions that support patients with high disease
burden and unmet need
- Oral presentations address treatment of moderate to severe
Crohn's disease, including efficacy and safety outcomes from the
SKYRIZI® (risankizumab-rzaa) pivotal clinical program as
well as late-breaking Phase 3 investigational data from the
upadacitinib 52-week maintenance trial
- Poster presentations include an analysis of the impact of
CREON® (pancrelipase) on patient-reported daily symptoms
in exocrine pancreatic insufficiency due to chronic pancreatitis or
pancreatic surgery
NORTH
CHICAGO, Ill., Oct. 24,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that 26 abstracts across its gastroenterology portfolio
will be presented at the American College of Gastroenterology (ACG)
Annual Scientific Meeting, October 21-26,
2022, in Charlotte, N.C.,
and virtually.
AbbVie's oral and poster presentations at ACG 2022 will
highlight data in digestive disorders and inflammatory bowel
diseases, including Crohn's disease (CD), ulcerative colitis (UC),
irritable bowel syndrome with constipation (IBS-C), irritable bowel
syndrome with diarrhea (IBS-D), chronic idiopathic constipation
(CIC) and exocrine pancreatic insufficiency (EPI). AbbVie is deeply
committed to providing research and innovative solutions to support
patients in their journey to manage their gastrointestinal
disease.
"At AbbVie, our thoughtfully designed clinical programs focus on
creating bodies of evidence that elevate our understanding of
immune-mediated GI conditions," said Celine
Goldberger, MD, PhD, vice president, head of US Medical
Affairs, AbbVie. "Pioneering research presented at ACG illustrates
our dedication to enhancing scientific understanding of how to
improve disease activity and shape the future of GI management,
beyond only managing symptoms and aiming to improve standards of
care."
AbbVie will share oral presentations from the
SKYRIZI® (risankizumab-rzaa) and RINVOQ®
(upadacitinib) Phase 3 clinical trial programs including
late-breaking data. Notable poster data include data on
SKYRIZI®, LINZESS® (linaclotide),
RINVOQ® (upadacitinib) and CREON®
(pancrelipase), as well as the impact of inflammatory bowel
disease. A database with all 26 AbbVie abstracts accepted for
presentation at ACG 2022 can be found here.
AbbVie abstracts presented at the 2022 ACG Annual Scientific
Meeting are outlined below.
Abstract
Title
|
Presentation
Details
All times
ET
|
Crohn's
Disease
|
|
Clinical and Endoscopic
Improvements with Risankizumab Induction and Maintenance Dosing
Versus Placebo are Observed Irrespective of Number of Prior Failed
Biologics
|
Oral
Presentation; Plenary Session 3A - IBD / Late Breaking
Abstracts; October 25; 2:35 to 2:45 PM
|
Fatigue Improvement
Correlates with Reductions in Work Productivity Impairment and
Related Indirect Cost in Patients with Crohn's disease: Post Hoc
Analysis of Two Phase 3 Induction Trials
|
October 24; 10:00 AM to
12:00 PM
|
52-Weeks Risankizumab
Subcutaneous Maintenance Dosing is Efficacious and Well Tolerated
in Patients with Moderate to Severe Crohn's Disease Who Had Delayed
Response to 12-Weeks IV Risankizumab Induction
|
Oral
Presentation; Plenary Session 3A - IBD / Late Breaking
Abstracts; October 25; 2:35 to 2:45 PM
|
Baseline and Early
Predictors of Response to Risankizumab Induction and Maintenance
Treatment in Patients with Moderate to Severe Crohn's
Disease
|
October 25; 10:00 AM to
12:00 PM
|
Induction and
Maintenance Treatment with Risankizumab is Superior to Placebo for
Achieving Symptomatic Relief in Patients with Moderate to Severe
Crohn's Disease
|
Oral
Presentation; Plenary Session 3A - IBD / Late Breaking
Abstracts; October 25; 2:15 to 2:25 PM
|
Risankizumab Results in
Improvements in Disease Activity Scores in Patients with Crohn's
Disease: Post-hoc Analysis of the Phase 3 Induction and Maintenance
Studies
|
October 24; 10:00 AM to
12:00 PM
|
Efficacy and Safety of
Upadacitinib Induction Therapy in Patients with Moderately to
Severely Active Crohn's Disease: Results from a Randomized Phase 3
U-EXCEL Study
|
October 24; 10:00 AM to
12:00 PM
|
Efficacy and Safety of
Upadacitinib Maintenance Therapy in Patients with Moderately to
Severely Active Crohn's Disease: Results from a Randomized Phase 3
U-ENDURE Maintenance Study
|
Oral
Presentation; Plenary Session 3A - IBD / Late Breaking
Abstracts; October 25; 3:25 to 3:35 PM
|
Ulcerative
Colitis
|
|
Benefit-risk Assessment
of Upadacitinib Treatment in Patients with Moderately to Severely
Active Ulcerative Colitis
|
October 23; 5:00 to
7:00 PM
|
Benefits of High Versus
Low Dose Upadacitinib as Maintenance Treatment in Ulcerative
Colitis Patients Who Were Responders to 8-week Induction with
Upadacitinib: Results from the U-ACHIEVE Phase 3 Maintenance
Trial
|
Oral
Presentation; Presidential Plenary Session 1; October 24; 8:00
to 8:12 AM
|
Matching-Adjusted
Indirect Comparison of Upadacitinib Versus Vedolizumab in Patients
with Moderate to Severe Ulcerative Colitis
|
October 24; 10:00 AM to
12:00 PM
|
Efficacy and Safety of
Upadacitinib in Patients with Moderately to Severely Active
Ulcerative Colitis Receiving 16 weeks' Extended Induction Treatment
Followed by 52 weeks' Maintenance Treatment in the
U-ACHIEVE/U-ACCOMPLISH Trials
|
Oral
Presentation; Plenary Session 4A - Colon / IBD; October 26;
9:30 to 9:40 AM
|
Efficacy and Safety of
Upadacitinib Maintenance Therapy in Patients with Moderately to
Severely Active Ulcerative Colitis: Final Results from the Phase 3
U-ACHIEVE Maintenance Study
|
October 24; 10:00 AM to
12:00 PM
|
Efficacy of
Upadacitinib Dose Escalation in a Phase 3 Long-Term Extension
Ulcerative Colitis Study
|
October 24; 3:00 to
5:00 PM
|
Impact of Inflammatory
Burden on Efficacy of Upadacitinib Maintenance Therapy in
Ulcerative Colitis: Results from the Phase 3 U-ACHIEVE
Study
|
October 25; 10:00 AM to
12:00 PM
|
Symptoms and Laboratory
Values as Proxies for Endoscopic and Histologic Clinical Endpoints
in Ulcerative Colitis: A Mediation Analysis Based on Upadacitinib
Phase 3 Induction Trials
|
October 24; 3:00 to
5:00 PM
|
Inflammatory Bowel
Disease (IBD)
|
|
A Longitudinal
Evaluation of Patients with Inflammatory Bowel Disease in Puerto
Rico
|
October 25; 3:00 to
5:00 PM
|
Economic Costs and
Trends in Inflammatory Bowel Disease-related Hospitalizations and
Surgery in the United States
|
October 25; 3:00 to
5:00 PM
|
Racial and Ethnic
Differences in Diagnosed Prevalence, Specialist Visits, and
Treatment Utilization of Inflammatory Bowel Disease: Retrospective
Analysis of US Claims Data
|
October 25; 3:00 to
5:00 PM
|
Evaluation of
Quality-of-Care Indicators Among Patients with Crohn's Disease and
Ulcerative Colitis in the United States: 2019–2020
|
October 24; 3:00 to
5:00 PM
|
Irritable Bowel
Syndrome with Constipation (IBS-C)
|
|
Predictors of Placebo
Response in Patients with Irritable Bowel Syndrome and
Constipation: A Post-hoc Analysis from Pooled Phase 2b/3 Studies
Assessing the Safety and Efficacy of Linaclotide
|
October 24; 10:00 AM to
12:00 PM
|
Disease Burden and
Care-seeking Behavior of Patients with Irritable Bowel Syndrome
with Constipation (IBS-C) in the United States
|
October 23; 5:00 to
7:00 PM
|
Chronic Idiopathic
Constipation (CIC)
|
|
Impact of Abdominal
Symptoms in Patients with Chronic Idiopathic Constipation (CIC) in
the United States
|
October 23; 5:00 to
7:00 PM
|
Irritable Bowel
Syndrome with Diarrhea (IBS-D)
|
|
Burden of Disease in
Patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) in the
United States
|
October 23; 5:00 to
7:00 PM
|
Exocrine Pancreatic
Insufficiency (EPI)
|
|
Development of a
Clinical Screening Tool for Exocrine Pancreatic Insufficiency (EPI)
in Patients with Chronic Pancreatitis (CP)
|
October 24; 3:00 to
5:00 PM
|
Impact of Pancrelipase
on Patient-Reported Daily Symptoms in Patients with Exocrine
Pancreatic Insufficiency due to Chronic Pancreatitis or Pancreatic
Surgery: Analysis of Randomized Trial Patient-Reported Daily
Symptoms
|
October 24; 3:00 to
5:00 PM
|
SKYRIZI (risankizumab) is part of a collaboration between
Boehringer Ingelheim and AbbVie, with AbbVie leading development
and commercialization of SKYRIZI globally.
Use of RINVOQ (upadacitinib) in Crohn's disease is not approved
and its safety and efficacy have not been evaluated by regulatory
authorities.
LINZESS (linaclotide) is part of a collaboration between AbbVie
and Ironwood Pharmaceuticals to share development and
commercialization of LINZESS in the
United States.
U.S. Use and Important Safety Information About
SKYRIZI® (risankizumab-rzaa)1
SKYRIZI is a prescription medicine used to treat adults
with:
- moderate to severe plaque psoriasis who may benefit from taking
injections or pills (systemic therapy) or treatment using
ultraviolet or UV light (phototherapy).
- active psoriatic arthritis (PsA).
- moderate to severe Crohn's disease
What is the most important information I should know about
SKYRIZI® (risankizumab-rzaa)?
SKYRIZI is a prescription medication that may cause serious
side effects, including:
Serious Allergic Reactions:
Stop using SKYRIZI and get emergency help right away if you get any
of the following symptoms of serious allergic reaction:
- Fainting, dizziness, feeling lightheaded (low blood
pressure)
- Swelling of your face, eyelids, lips, mouth, tongue, or
throat
- Trouble breathing or throat tightness
- Chest tightness
- Skin rash, hives
- Itching
Infections:
SKYRIZI may lower the ability of your immune system to fight
infections and may increase your risk of infections. Your
healthcare provider should check you for infections and
tuberculosis (TB) before starting treatment with SKYRIZI and may
treat you for TB before you begin treatment with SKYRIZI if you
have a history of TB or have active TB. Your healthcare provider
should watch you closely for signs and symptoms of TB during and
after treatment with SKYRIZI.
- Tell your healthcare provider right away if you have an
infection or have symptoms of an infection, including:
-
- fever, sweats, or chills
- muscle aches
- weight loss
- cough
- warm, red, or painful skin or sores on your body different from
your psoriasis
- diarrhea or stomach pain
- shortness of breath
- blood in your mucus (phlegm)
- burning when you urinate or urinating more often than
normal
Do not use SKYRIZI if you are allergic to
risankizumab-rzaa or any of the ingredients in SKYRIZI.
Before using SKYRIZI, tell your healthcare provider about all
of your medical conditions, including if you:
- have any of the conditions or symptoms listed in the section
"What is the most important information I should know about
SKYRIZI?"
- have an infection that does not go away or that keeps coming
back.
- have TB or have been in close contact with someone with
TB.
- have recently received or are scheduled to receive an
immunization (vaccine). Medications that interact with the immune
system may increase your risk of getting an infection after
receiving live vaccines. You should avoid receiving live vaccines
right before, during, or right after treatment with SKYRIZI. Tell
your healthcare provider that you are taking SKYRIZI before
receiving a vaccine.
- are pregnant or plan to become pregnant. It is not known if
SKYRIZI can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if
SKYRIZI passes into your breast milk.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most
important information I should know about SKYRIZI?"
Liver problems in people with Crohn's disease: A
person with Crohn's disease who received SKYRIZI by intravenous
infusion developed changes in liver blood tests with a rash that
led to hospitalization. Your doctor will do blood tests to check
your liver before, during, and up to 12 weeks of treatment and may
stop treatment with SKYRIZI if you develop liver problems. Tell
your doctor right away if you notice any of the following symptoms:
unexplained rash, nausea, vomiting, stomach(abdominal) pain,
tiredness(fatigue), loss of appetite, yellowing of the skin and
eyes (jaundice) and dark urine.
The most common side effects of SKYRIZI in people treated for
Crohn's Disease include: upper respiratory infections,
headache, joint pain, stomach (abdominal) pain, injection site
reactions, and fungal skin infections.
The most common side effects of SKYRIZI in people treated for
plaque psoriasis and psoriatic arthritis include: upper
respiratory infections, headache, feeling tired, injection site
reactions, and fungal skin infections.
These are not all the possible side effects of SKYRIZI. Call
your doctor for medical advice about side effects.
Use SKYRIZI exactly as your healthcare provider tells you to use
it.
SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a
600mg/10mL vial for intravenous infusion, and a 180 mg/1.2 mL or
360mg/2.4mL single-dose prefilled cartridge with on-body
injector.
This is the most important information to know about SKYRIZI.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help. Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for Full Prescribing
Information and Medication Guide for
SKYRIZI.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
U.S. Uses and Important Safety Information About
RINVOQ® (upadacitinib)2
RINVOQ is a prescription medicine used to treat:
- Adults with moderate to severe rheumatoid arthritis
(RA) when 1 or more medicines called tumor necrosis factor
(TNF) blockers have been used, and did not work well or could not
be tolerated.
- Adults with active psoriatic arthritis (PsA) when 1
or more medicines called TNF blockers have been used, and did not
work well or could not be tolerated.
- Adults with moderate to severe active ulcerative colitis
(UC) when 1 or more medicines called TNF blockers have
been used, and did not work well or could not be tolerated.
- Adults with active ankylosing spondylitis (AS) when 1 or
more medicines called TNF blockers have been used, and did not work
well or could not be tolerated.
- Adults with active non-radiographic axial spondyloarthritis
(nr-axSpA) with objective signs of inflammation when a TNF
blocker medicine has been used, and did not work well or could not
be tolerated.
It is not known if RINVOQ is safe and effective in children with
juvenile idiopathic arthritis, psoriatic arthritis, ulcerative
colitis, ankylosing spondylitis or non-radiographic axial
spondyloarthritis.
- Adults and children 12 years of age and older with moderate
to severe eczema (atopic dermatitis [AD]) that did not respond
to previous treatment and their eczema is not well controlled with
other pills or injections, including biologic medicines, or when
the use of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and
older weighing at least 88 pounds (40 kg) with atopic
dermatitis.
It is not known if RINVOQ is safe and effective in children
under 12 years of age with atopic dermatitis.
What is the most important information I should know about
RINVOQ?
RINVOQ may cause serious side effects, including:
- Serious infections. RINVOQ can lower your ability to
fight infections. Serious infections have happened while taking
RINVOQ, including tuberculosis (TB) and infections caused by
bacteria, fungi, or viruses that can spread throughout the body.
Some people have died from these infections. Your healthcare
provider (HCP) should test you for TB before starting RINVOQ and
check you closely for signs and symptoms of TB during treatment
with RINVOQ. You should not start taking RINVOQ if you have any
kind of infection unless your HCP tells you it is okay. If you get
a serious infection, your HCP may stop your treatment until your
infection is controlled. You may be at higher risk of developing
shingles (herpes zoster).
- Increased risk of death in people 50 years and older who
have at least 1 heart disease (cardiovascular) risk
factor.
- Cancer and immune system problems. RINVOQ may increase
your risk of certain cancers. Lymphoma and other cancers, including
skin cancers, can happen. Current or past smokers are at higher
risk of certain cancers, including lymphoma and lung cancer. Follow
your HCP's advice about having your skin checked for skin cancer
during treatment with RINVOQ. Limit the amount of time you spend in
sunlight. Wear protective clothing when you are in the sun and use
sunscreen.
- Increased risk of major cardiovascular (CV) events, such as
heart attack, stroke, or death, in people 50 years and older who
have at least 1 heart disease (CV) risk factor, especially if you
are a current or past smoker.
- Blood clots: Blood clots in the veins of the legs or
lungs and arteries can happen with RINVOQ. This may be
life-threatening and cause death. Blood clots in the veins of the
legs and lungs have happened more often in people who are 50 years
and older and with at least 1 heart disease (CV) risk factor.
- Allergic reactions. Symptoms such as rash (hives),
trouble breathing, feeling faint or dizzy, or swelling of your
lips, tongue, or throat, that may mean you are having an allergic
reaction have been seen in people taking RINVOQ. Some of these
reactions were serious. If any of these symptoms occur during
treatment with RINVOQ, stop taking RINVOQ and get emergency medical
help right away.
- Tears in the stomach or intestines and changes in certain
laboratory tests. Your HCP should do blood tests before you
start taking RINVOQ and while you take it. Your HCP may stop your
RINVOQ treatment for a period of time if needed because of changes
in these blood test results.
Do not take RINVOQ if you are allergic to upadacitinib or any
of the ingredients in RINVOQ. See the Medication Guide or
Consumer Brief Summary for a complete list of ingredients.
What should I tell my HCP BEFORE starting RINVOQ?
Tell your HCP if you:
- Are being treated for an infection, have an infection that
won't go away or keeps coming back, or have symptoms of an
infection such as:
-
- Fever, sweating, or chills
- Shortness of breath
- Warm, red, or painful skin or sores on your body
- Muscle aches
- Feeling tired
- Blood in phlegm
- Diarrhea or stomach pain
- Cough
- Weight loss
- Burning when urinating or urinating more often than normal
- Have TB or have been in close contact with someone with
TB.
- Are a current or past smoker.
- Have had a heart attack, other heart problems, or stroke.
- Have had any type of cancer, hepatitis B or C, shingles (herpes
zoster), blood clots in the veins of your legs or lungs,
diverticulitis (inflammation in parts of the large intestine), or
ulcers in your stomach or intestines.
- Have other medical conditions including liver problems, low red
or white blood cell counts, diabetes, chronic lung disease, HIV, or
a weak immune system.
- Live, have lived, or have traveled to parts of the country,
such as the Ohio and Mississippi
River valleys and the Southwest, that increase your risk of getting
certain kinds of fungal infections. If you are unsure if you've
been to these types of areas, ask your HCP.
- Have recently received or are scheduled to receive a vaccine.
People who take RINVOQ should not receive live vaccines.
- Are pregnant or plan to become pregnant. Based on findings in
animal studies, RINVOQ may harm your unborn baby. Your HCP will
check whether or not you are pregnant before you start RINVOQ. You
should use effective birth control (contraception) to avoid
becoming pregnant during treatment with RINVOQ and for 4 weeks
after your last dose.
- Are breastfeeding or plan to breastfeed. RINVOQ may pass into
your breast milk. Do not breastfeed during treatment with RINVOQ
and for 6 days after your last dose.
Tell your HCP about all the medicines you
take, including prescription and over-the-counter
medicines, vitamins, and herbal supplements. RINVOQ and other
medicines may affect each other, causing side effects.
Especially tell your HCP if you take:
- Medicines for fungal or bacterial infections
- Rifampicin or phenytoin
- Medicines that affect your immune system
If you are not sure if you are taking any of these medicines,
ask your HCP or pharmacist.
What should I do or tell my HCP AFTER starting
RINVOQ?
- Tell your HCP right away if you have any symptoms of an
infection. RINVOQ can make you more likely to get infections or
make any infections you have worse
- Get emergency help right away if you have any symptoms of a
heart attack or stroke while taking RINVOQ, including:
-
- Discomfort in the center of your chest that lasts for more than
a few minutes or that goes away and comes back
- Severe tightness, pain, pressure, or heaviness in your chest,
throat, neck, or jaw
- Pain or discomfort in your arms, back, neck, jaw, or
stomach
- Shortness of breath with or without chest discomfort
- Breaking out in a cold sweat
- Nausea or vomiting
- Feeling lightheaded
- Weakness in one part or on one side of your body
- Slurred speech
- Tell your HCP right away if you have any signs or symptoms of
blood clots during treatment with RINVOQ, including:
-
- Swelling
- Pain or tenderness in one or both legs
- Sudden unexplained chest or upper back pain
- Shortness of breath or difficulty breathing
- Tell your HCP right away if you have a fever or stomach-area
pain that does not go away, and a change in your bowel habits.
What are other possible side effects of
RINVOQ?
Common side effects include upper respiratory tract infections
(common cold, sinus infections), shingles (herpes zoster), herpes
simplex virus infections (including cold sores), bronchitis,
nausea, cough, fever, acne, headache, increased blood levels of
creatine phosphokinase, allergic reactions, inflammation of hair
follicles, stomach-area (abdominal) pain, increased weight, flu,
tiredness, lower number of certain types of white blood cells
(neutropenia, lymphopenia), muscle pain, flu-like illness, rash,
increased blood cholesterol levels, and increased liver enzyme
levels.
Separation or tear to the lining of the back part of the eye
(retinal detachment) has happened in people with atopic dermatitis
treated with RINVOQ. Call your HCP right away if you have any
sudden changes in your vision during treatment with RINVOQ.
These are not all the possible side effects of RINVOQ.
How should I take RINVOQ?
RINVOQ is taken once a day with or without food. Do not split,
crush, or chew the tablet. Take RINVOQ exactly as your HCP tells
you to use it. RINVOQ is available in 15 mg, 30 mg and 45 mg
extended-release tablets.
This is the most important information to know about RINVOQ.
For more information, talk to your HCP.
You are encouraged to report negative side effects of
prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.
If you are having difficulty paying for your medicine, AbbVie
may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn
more.
Please click here for the Full Prescribing
Information and Medication Guide.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
U.S. Uses and Important Safety Information About
LINZESS® (linaclotide)3
USES
LINZESS® (linaclotide) is a prescription medication
used in adults to treat irritable bowel syndrome with constipation
(IBS-C) and chronic idiopathic constipation (CIC). "Idiopathic"
means the cause of the constipation is unknown. It is not known
if LINZESS is safe and effective in children less than 18 years of
age.
IMPORTANT RISK INFORMATION
- Do not give LINZESS to children who are less than 2 years of
age. It may harm them. LINZESS can cause severe diarrhea and
your child could get severe dehydration (loss of a large amount of
body water and salt).
- Do not take LINZESS if a doctor has told you that you have a
bowel blockage (intestinal obstruction).
Before you take LINZESS, tell your doctor about your medical
conditions, including if you are:
- Pregnant or plan to become pregnant. It is not known if LINZESS
will harm your unborn baby.
- Breastfeeding or plan to breastfeed. You and your doctor should
decide if you will take LINZESS and breastfeed.
Tell your doctor about all the medicines you take,
including prescription and over-the-counter medicines, vitamins,
and herbal supplements.
Side Effects
LINZESS can cause serious side effects, including diarrhea,
which is the most common side effect and can sometimes be
severe. Diarrhea often begins within the first 2 weeks of
LINZESS treatment. Stop taking LINZESS and call your doctor
right away if you get severe diarrhea during treatment with
LINZESS.
Other common side effects of LINZESS include gas, stomach-area
(abdominal) pain, swelling, or a feeling of fullness or pressure in
your abdomen (distension). Call your doctor or go to the nearest
hospital emergency room right away if you develop unusual or severe
stomach-area (abdominal) pain, especially if you also have bright
red, bloody stools or black stools that look like tar.
These are not all the possible side effects of LINZESS. For more
information, ask your doctor or pharmacist.
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.
If you are having difficulty paying for your medicine, AbbVie
and Ironwood may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.
Please see full Prescribing Information including Boxed
Warning.
U.S. Use and Important Safety Information About
CREON® (pancrelipase)4
CREON® (pancrelipase) is a prescription medicine used
to treat people who cannot digest food normally because their
pancreas does not make enough enzymes due to cystic fibrosis,
swelling of the pancreas that lasts a long time (chronic
pancreatitis), removal of some or all of the pancreas
(pancreatectomy), or other conditions.
Important Safety Information
- CREON may increase your chance of having a rare bowel disorder
called fibrosing colonopathy. Tell your doctor if you have a
history of intestinal blockage, or scarring or thickening of your
bowel wall (fibrosing colonopathy). The risk of having this
condition may be reduced by following the dosing instructions that
your doctor gave you.
- Do not crush or chew CREON capsules or their contents, and
do not hold the capsule or capsule contents in your mouth.
Crushing, chewing, or holding the CREON capsules in your mouth may
cause irritation in your mouth. Talk to your doctor or consult the
CREON Medication Guide for how to take CREON if you have trouble
swallowing capsules. Always take CREON with a meal or snack and
enough liquid to swallow CREON completely. Take CREON exactly as
your doctor tells you.
- Tell your doctor right away if you have unusual or
severe: stomach (abdominal) pain, bloating, trouble passing
stool, nausea, vomiting, diarrhea, worsening of painful, swollen
joints (gout), or allergic reactions, including trouble with
breathing, skin rashes, or swollen lips.
- The most common side effects include increased (hyperglycemia)
or decreased (hypoglycemia) blood sugars, pain in your stomach area
(abdominal area); frequent or abnormal bowel movements, gas;
vomiting, dizziness, and sore throat and cough.
- CREON and other pancreatic enzyme products are made from the
pancreas of pigs, the same pigs people eat as pork. These pigs may
carry viruses. Although it has never been reported, it may be
possible for a person to get a viral infection from taking
pancreatic enzyme products that come from pigs.
Refer to the CREON Medication Guide and full Prescribing
Information every time you refill your prescription because
information may change. Tell your healthcare provider if you have
any symptom or side effect that bothers you or that does not go
away.
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.
If you are having difficulty paying for your medication,
AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to
learn more.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across our
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this news release are, or may be
considered, forward-looking statements for purposes of the Private
Securities Litigation Reform Act of 1995. The words "believe,"
"expect," "anticipate," "project" and similar expressions, among
others, generally identify forward-looking statements. AbbVie
cautions that these forward-looking statements are subject to risks
and uncertainties that may cause actual results to differ
materially from those indicated in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
failure to realize the expected benefits from AbbVie's acquisition
of Allergan plc ("Allergan"), failure to promptly and effectively
integrate Allergan's businesses, competition from other products,
challenges to intellectual property, difficulties inherent in the
research and development process, adverse litigation or government
action, changes to laws and regulations applicable to our industry
and the impact of public health outbreaks, epidemics or pandemics,
such as COVID-19. Additional information about the economic,
competitive, governmental, technological and other factors that may
affect AbbVie's operations is set forth in Item 1A, "Risk Factors,"
of AbbVie's 2021 Annual Report on Form 10-K, which has been filed
with the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
US-IMMG-220338
References:
- SKYRIZI (risankizumab-rzaa) [Package Insert]. North
Chicago, Ill.: AbbVie Inc.
- RINVOQ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
- LINZESS (linaclotide) [Package Insert]. Madison, NJ.:
Allergan USA, Inc.
- CREON (pancrelipase) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
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SOURCE AbbVie