Moderate to Severe
Pediatric Crohn's Disease

HUMIRA may be right for your child with
moderate to severe Crohn's disease.

After you and your child’s doctor have discussed HUMIRA,
here are some things you should know.

In a clinical study, at 26 weeks, more than half of the patients on HUMIRA saw significant symptom relief and many achieved remission. HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in children 6 years of age and older with moderate to severe Crohn’s disease when certain other treatments have not worked well enough.


A look at our history1-3

HUMIRA was first approved in the United States in 2002 as a biologic therapy. It has been studied in 76 different clinical trials worldwide, and it’s approved in the US for 8 different conditions, including moderate to severe Crohn’s disease in adults in 2007, moderate to severe juvenile idiopathic arthritis in children 2 years of age and older in 2008, and moderate to severe pediatric Crohn's disease in children 6 years of age and older in 2014. Over one million patients are currently being treated with HUMIRA worldwide.*3

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.

HUMIRA is a prescription medicine used alone, with methotrexate, or with certain other medicines to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis in children 4 years of age and older.

*As of June 2016.

Important information about HSTCL

Some people receiving TNF blockers including HUMIRA developed a rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL), which often results in death. Most of these people were male teenagers or young men and also were being treated for inflammatory bowel disease with another medicine called Imuran®† (azathioprine) or Purinethol®† (6-mercaptopurine, 6–MP).

All trademarks are the property of their respective companies.

HUMIRA is not right for everyone.


Learn About How HUMIRA Works

Personalized support for you and your child

You may choose to have a HUMIRA Ambassador who is provided at no additional cost and offers one-to-one personalized support. Your Ambassador has received in-depth training on pediatric Crohn's disease and HUMIRA.

HUMIRA Ambassador services are available through HUMIRA Complete, an optional product support program offered to you by AbbVie that includes services such as injection training from a local registered nurse, financial assistance information, a HUMIRA Complete Co-pay Savings Card (if eligible), and more. Your HUMIRA Ambassador can provide you and your child with one-to-one customized education and support as well as assist you with the other resources provided through HUMIRA Complete.

Call 1.800.4HUMIRA to connect with a HUMIRA Ambassador today (select the option to speak with a nurse).

Terms and Conditions apply. This benefit covers HUMIRA® (adalimumab) alone or, for rheumatology patients, HUMIRA plus one of the following medications: methotrexate, leflunomide (Arava®), or hydroxychloroquine (Plaquenil®). Eligibility: In Massachusetts, co-pay assistance is not available for products with certain generic equivalents (for example, any product with an AB-rated generic equivalent). Available to patients with commercial prescription insurance coverage for HUMIRA. Co-pay assistance program is not available to patients receiving prescription reimbursement under any federal, state or government-funded insurance programs (for example, Medicare, Medicaid, TRICARE, Department of Defense or Veteran's Affairs programs) or where prohibited by law. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance.

Next Page: Considering HUMIRA

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

IMPORTANT SAFETY INFORMATION
ABOUT HUMIRA® (adalimumab)1

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, even if your TB test was negative. 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. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas.
  • 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. Children should be brought up to date on all vaccines before starting HUMIRA.
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
  • Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

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 (decreased blood cells that help fight infections or stop bleeding). 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). These problems can lead to liver failure and death.
  • 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 (pain, 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 certain other medications. 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.
    • Moderate to severe hidradenitis suppurativa (HS) in adults.
  • 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.
  • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.

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In This Section

Find out how
HUMIRA works.

How HUMIRA Works

Watch how HUMIRA
works inside the body.


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.

References: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc. 2. Burmester GR, Panaccione R, Gordon KB, et al. Adalimumab: long-term safety in 23,458 patients from global clinical trials in rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, and Crohn’s disease. Ann Rheum Dis. 2013;72(4):517-524. 3. Data on file, AbbVie Inc.

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Information from AbbVie

HUMIRA Use1

HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in children 6 years of age and older with moderate to severe Crohn’s disease when certain other treatments have not worked well enough.

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.