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Understanding Ulcerative Colitis in Children

A chronic, inflammatory disease

Ulcerative colitis (UC) belongs to a larger group of illnesses called inflammatory bowel diseases (IBD). It is associated with inflammation of the large intestine (colon and rectum) in the gastrointestinal (GI) tract.

Although the exact cause of pediatric UC is not fully understood, research shows that it could be the result of several factors, such as genetics, the environment, or an immune system problem.

Ulcerative colitis is a chronic—or long-lasting—disease that can worsen over time if left untreated. Fortunately, there are medicines available that may help patients, like your child, experience symptom relief and achieve remission.

Inflammation and the immune system

Inflammation is our immune system’s way of protecting us from bacteria, viruses, and other potentially harmful substances. In people with UC, the immune system mistakenly attacks the inner lining of the large intestine. This results in excess inflammation that can lead to the symptoms of UC.

Although it isn’t known for sure what causes the excess inflammation, too much of the protein TNF alpha may be to blame. Our immune system naturally produces TNF alpha, but people with UC may be producing too much of it.

Understanding ulcerative colitis symptoms in children

Because UC is a chronic disease, your child’s symptoms can change or worsen over time. Children can go through periods when they experience few or no symptoms, known as remission, as well as periods when symptoms can become more frequent and intense.

If your child is experiencing symptoms, even while being treated for UC, it could be time to talk with your child’s doctor about a different treatment.

Common symptoms your child may be experiencing

The symptoms of UC can vary over time and often depend on the level of severity. It’s best to work with your child’s doctor to determine the severity of your child’s condition.

Children with UC may also be affected by age-related issues, including problems with gaining weight, slowed growth, short stature, or delayed puberty.

Common symptoms of pediatric UC include:

  • Diarrhea with blood
  • Abdominal discomfort
  • An urgent need to have a bowel movement
  • Feeling tired
  • Nausea or loss of appetite
  • Weight loss
  • Fever
  • Anemia—a condition in which the body has fewer red blood cells than normal (this is something your doctor is able to diagnose with a blood test)

Remission: the goal of pediatric UC treatment

The goal of UC treatment is remission—few or no symptoms. If your child is taking medication for UC and still experiencing symptoms, talk to their doctor about other treatment options that may help. 

HUMIRA, a biologic, blocks TNF alpha, a source of inflammation that may be contributing to your child’s UC symptoms. At your child’s next appointment, ask your doctor if treatment with HUMIRA may be able to provide symptom relief and remission.


HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

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 or with methotrexate.
    • 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 hidradenitis suppurativa (HS) in people 12 years and older.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. 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) in adults and children 2 years of age and older.

US-HUM-210186

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 are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding

IMPORTANT SAFETY INFORMATION1

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

IMPORTANT SAFETY INFORMATION1

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

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

IMPORTANT SAFETY INFORMATION1

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

IMPORTANT SAFETY INFORMATION1

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. 

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

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 or with methotrexate.
    • 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 hidradenitis suppurativa (HS) in people 12 years and older.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. 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) in adults and children 2 years of age and older.

US-HUM-210186