Moderate to Severe
Crohn's Disease
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What is Crohn's disease?
What can it mean for you?

Crohn's disease is a chronic and unpredictable disease.

Crohn's disease belongs to a larger group of illnesses called inflammatory bowel disease (IBD). It is associated with inflammation of the digestive tract, or gastrointestinal (GI) tract, which runs from the mouth to the anus, and includes the stomach and intestines. It more commonly affects the end of the small intestine and the large intestine.

HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in adults with moderate to severe Crohn's disease who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.

Crohn's is often classified as an immune-mediated inflammatory disease.

When you have this type of disease, inflammation is due to an abnormal and prolonged response by your body's immune system. For people with Crohn's, this inflammation occurs in the GI tract.


How do you get Crohn's disease?

The exact cause is unknown.

Even though the cause of Crohn's is not fully understood, it's thought to be a result of a combination of factors:

Genetics

  • About 5% to 20% of patients have a close relative with either Crohn's or ulcerative colitis
  • A person's risk of having Crohn's is about 10X greater if they have a relative with it
  • If the relative with Crohn's is a brother or sister, a person’s risk of having it is 30X greater
  • While several genes were found to be associated with Crohn's, many people who carry these genes do not develop Crohn's

Immune System

  • Researchers believe substances in the intestines are mistaken for invading substances (antigens)
  • To combat these antigens, your immune system causes temporary inflammation, which is reduced as you regain health
  • With Crohn's, inflammation can persist long after your immune system should have finished its job

Environment

  • Immune responses in the GI tract can be due to exposure to foreign substances in the environment
  • Inflammation can also be triggered by microorganisms and intestinal bacteria
  • Crohn’s is more common in urban than in rural areas
  • It‘s more common in northern than in southern climates
  • Certain foods can aggravate symptoms in some people, but there have been no studies to suggest that diet can either cause or treat Crohn's
  • There's no specific diet that patients with the disease should follow (although it's always advisable to eat a balanced diet)
  • There's no convincing evidence that Crohn's results from food allergies

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There are 5 types of Crohn's disease that affect different locations within the GI tract. Learn about each.

Each type of Crohn's disease has its own specific set of symptoms.

Click on circles in the above illustration for a closer look.


Stay informed. It can help you ask the right questions.

While there are many medications available to treat moderate to severe Crohn's disease, the amount of treatment information can feel overwhelming—whether you are newly diagnosed or are a long-time patient.

That’s why being well informed is an important first step toward finding a treatment that will be effective for you. Learning about your options and setting goals for your treatment can help you and your doctor make the best decisions about your care.

Learn About Treatment & Biologics

Your safety is important to us.
Learn about our Important Safety Information.

IMPORTANT SAFETY INFORMATION
ABOUT HUMIRA® (adalimumab)1

Next Page: Crohn‘s Disease Symptoms

What is the most important information I should know about HUMIRA?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

  • Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB.

  • Cancer. For children and adults taking TNF blockers, including HUMIRA, the chance of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers including HUMIRA, your chance of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.


What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

  • Have an infection, are being treated for infection, or have symptoms of an infection
  • Get a lot of infections or infections that keep coming back
  • Have diabetes
  • Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB
  • Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis
  • Have or have had hepatitis B
  • Are scheduled for major surgery
  • Have or have had cancer
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed

Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).


What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
  • Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
  • Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.


Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.


Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

  • Fever, sweats, or chills
  • Muscle aches
  • Cough
  • Shortness of breath
  • Blood in phlegm
  • Weight loss
  • Warm, red, or painful skin or sores on your body
  • Diarrhea or stomach pain
  • Burning when you urinate
  • Urinating more often than normal
  • Feeling very tired

HUMIRA is given by injection under the skin.


This is the most important information to know about HUMIRA. For more information, talk to your health care provider.

 

Uses

 

HUMIRA is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
    • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
  • In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
  • To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy, and are under the care of a doctor who will decide if other systemic therapies are less appropriate.

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In This Section

How are Crohn's
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affecting you?

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Crohn's at a Glance

It's an immune-mediated disease that can affect the entire GI tract from the mouth to the anus.

Common Symptoms

  • Diarrhea
  • Abdominal pain or cramping

Causes

Exact causes are unknown, but are believed to be a combination of factors, including:

  • Genetics
  • Environment
  • Immune System

Who's Affected

  • Affects men and women equally
  • Occurs more commonly in young adults
  • Can affect any ethnic group, but mostly Caucasians

Please see the Full Prescribing Information, including the Medication Guide, for HUMIRA.

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 cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

Please see accompanying full Prescribing Information, including Patient Instructions for Use in the Medication Guide and discuss it with your doctor.

Legal Notices/Privacy Policy. Copyright 2013, AbbVie Inc., North Chicago, Illinois, U.S.A. If you have any questions about AbbVie’s HUMIRA.com website that have not been answered click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

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HUMIRA Use1

HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in adults with moderate to severe Crohn’s disease who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and achieve clinical remission in these adults who have also lost response to or are unable to tolerate infliximab.

SAFETY CONSIDERATIONS1

Serious infections have happened in people taking HUMIRA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. HUMIRA may increase the chance of getting lymphoma, including a rare kind, or other cancers. HUMIRA can cause serious side effects including hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, heart failure, certain immune reactions including a lupus-like syndrome, liver problems, and new or worsening psoriasis.