Moderate to Severe
Pediatric Crohn's Disease

HUMIRA offers both treatment and support
for you and your child.

HUMIRA may be right for your child.

After you and your child’s doctor have discussed HUMIRA, here are some things you should know. The goals of pediatric Crohn's disease management include achieving remission (few or no symptoms) and maintaining 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.

In addition, HUMIRA Ambassadors are available to provide support and guidance for you and your child throughout the duration of his or her treatment.


Bring your child into the
treatment discussion.

You know your child. When you feel that he or she is ready, you may want to include your child in discussions with the doctor about his or her condition and treatment. Remember to ask if he or she understands what the doctor has said.

Talking about and sharing this decision may help your child realize the importance of following treatment as directed by his or her doctor, and may give your child a better understanding of his or her condition.


Many Crohn's symptoms may
be caused by inflammation.

Many people with immune-mediated inflammatory diseases such as Crohn's disease produce too much tumor necrosis factor (TNF). TNF is a protein that is found in your body and is part of your immune system. However, in patients with Crohn's disease, this overproduction of TNF can cause inflammation in the digestive or gastrointestinal (GI) tract, which can contribute to Crohn's symptoms.

HUMIRA targets and blocks TNF.

HUMIRA belongs to a class of biologic medicines known as TNF blockers. Overproduction of TNF in the GI tract is associated with Crohn's disease. HUMIRA specifically binds to TNF to block its action. This helps reduce the inflammation that can lead to Crohn's symptoms.

How HUMIRA Works
discuss your Crohn’s treatment goals with your gastroenterologist

Starting your child on HUMIRA

It's understandable that you may have some questions about starting your child on a new treatment. That's why we want to provide you with the information and support you need as your child starts HUMIRA.

One resource at your disposal is your HUMIRA Ambassador, who has received in-depth training on pediatric Crohn's disease and HUMIRA, available to you at no additional cost. Your HUMIRA Ambassador will work with you and your child during the onboarding process as well as provide education and support throughout your child’s treatment. They are available to answer questions about injecting HUMIRA, and they can also arrange for in-home injection training from a local registered nurse. HUMIRA Ambassadors do not give medical advice and will direct you to your child's health care professional for any treatment-related questions, including further referrals.


Learn how to give HUMIRA correctly.

If the doctor decides that you are able to give your child injections at home, you should receive training by a health care professional on the right way to prepare and inject HUMIRA. Do not try to inject HUMIRA until you have been shown the right way to give the injections. The doctor will take your child's weight into consideration when deciding the appropriate dose. Your child’s first injection must be given under the supervision of a health care professional. Remember to keep your HUMIRA refrigerated in its original container until ready for use.

With HUMIRA, you may not have to make an appointment and travel to the doctor’s office for every dose. HUMIRA offers you the flexibility to administer your child’s medicine in the comfort of your home. Your child’s doctor will follow up with you on a regular basis. Refer to the Patient Instructions for Use for the HUMIRA Pen or the prefilled syringe and the Medication Guide for more information on the right way to inject HUMIRA.

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 child’s doctor if he or she is experiencing any side effect that is bothersome or that does not go away.


Step-by-step instructional videos are also available to help with learning how to inject HUMIRA.

We also want to provide additional information that may help you become more familiar with giving your child his or her injection. Here are some Tips for Creating a Positive Injection Environment when giving an injection.


HUMIRA dosing

Important: You must pay attention to your child’s starting dose—it is different than his or her maintenance dose and is a critical part of taking HUMIRA as prescribed. The doctor will take your child's weight into consideration when deciding the appropriate dose. Your child’s first injection must be given under the supervision of a health care professional. Remember to keep HUMIRA refrigerated in its original container until ready for use.

If your child weighs from 37 to 87 lbs

Starting Dose

On Day 1*
Two 40 mg prefilled
syringes (80 mg)
on Day 1 you will inject 2 HUMIRA Pens (80 mg). On Day 15 you will inject 1 HUMIRA Pens (40 mg). on Day 1 you will inject 2 HUMIRA Pens (80 mg). On Day 15 you will inject 1 HUMIRA Pens (40 mg).
On Day 15
One 40 mg
prefilled syringe
on Day 1 you will inject 2 HUMIRA Pens (80 mg). On Day 15 you will inject 1 HUMIRA Pens (40 mg).

Continuing Dose

On Day 29 and every
other week thereafter
on Day 29 and every other week thereafter you will inject 1 HUMIRA Pen (40 mg). One 20 mg prefilled syringe

If your child weighs 88 lbs or more

Starting Dose

On Day 1
Four 40 mg prefilled
syringes (160 mg)
on Day 1 you will inject 4 HUMIRA Pens (160 mg). On Day 15 you will inject 2 HUMIRA Pens (80 mg). on Day 1 you will inject 4 HUMIRA Pens (160 mg). On Day 15 you will inject 2 HUMIRA Pens (80 mg). on Day 1 you will inject 4 HUMIRA Pens (160 mg). On Day 15 you will inject 2 HUMIRA Pens (80 mg). on Day 1 you will inject 4 HUMIRA Pens (160 mg). On Day 15 you will inject 2 HUMIRA Pens (80 mg).
On Day 15*
Two 40 mg prefilled
syringes (80 mg)
on Day 1 you will inject 4 HUMIRA Pens (160 mg). On Day 15 you will inject 2 HUMIRA Pens (80 mg). on Day 1 you will inject 4 HUMIRA Pens (160 mg). On Day 15 you will inject 2 HUMIRA Pens (80 mg).

Continuing Dose

On Day 29 and every
other week thereafter
on Day 29 and every other week thereafter you will inject 1 HUMIRA Pen (40 mg). One 40 mg prefilled syringe

* 80 mg dose is given as 2 injections in one day.
If your child weighs 88 lbs or more, the first dose (160 mg) can be administered as 4 injections in one day or as 2 injections per day for 2 consecutive days.
HUMIRA is also available in 40 mg prefilled Pens.

HUMIRA has not been studied in pediatric patients with Crohn’s disease less than 6 years old.

Next Page: How HUMIRA Works

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

We understand that
starting your child
on a new treatment
can be challenging.

Learn More

Learn about the education and one-to-one support that a HUMIRA Ambassador can offer you and your child.


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.

1299985-1678907


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.