Moderate to Severe
Pediatric Crohn's Disease

Frequently Asked Questions About HUMIRA

Whether your child has already started on HUMIRA or if you are considering it, there are some questions you may have. Take a look below to find some answers that may help you as you consider your child’s treatment options. For further assistance, read about what to expect with HUMIRA or call 1.800.4HUMIRA.

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

You should discuss the potential benefits and risks of HUMIRA with your child's doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your child's immune system to fight infections. Your child should not start taking HUMIRA if he or she has any kind of infection unless your child's 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 child's doctor should test your child for TB before starting HUMIRA, and check your child closely for signs and symptoms of TB during treatment with HUMIRA. If your child's doctor feels your child is at risk, he or she 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, the 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 child’s doctor if he or she has a bump or open sore that doesn't heal.

Please see "What are the possible side effects with HUMIRA?" for additional information regarding possible side effects. Also, please read the Medication Guide and discuss it with your doctor.

See more Important Safety Information for HUMIRA.

How does exposure to illnesses such as chicken pox affect my child?

It is important that you make your child's school nurse and teachers aware that your child is taking HUMIRA. They should inform you of any infections (chicken pox, mumps, measles, etc.) that your child might be exposed to at school. You should call the prescribing doctor if this occurs.

What should I do about my child’s vaccination schedule?

Discuss your concerns with your child’s prescribing doctor. Your child should be brought up to date with all immunizations prior to starting HUMIRA. Live vaccines should not be given with HUMIRA. Except for live virus vaccines, your child may still receive vaccines while on HUMIRA.

Should my child get a flu vaccination (“flu shot”) if he or she is taking HUMIRA?

As you may know, HUMIRA affects the immune system and can lower your child’s ability to fight infections like seasonal flu or H1N1. According to the US Centers for Disease Control (CDC), the most effective way to prevent the flu is to get an annual vaccination.

There are currently 2 types of vaccines available for H1N1 and the seasonal flu:

  • An injectable form, given with a syringe, does not contain a live form of the virus
  • An intranasal form, which is administered as a mist in your child’s nose, contains a weakened live form of the virus. The intranasal forms are live vaccines, and patients receiving HUMIRA should not receive live vaccines.

Always tell any doctor who is treating your child about all medications your child is taking, including HUMIRA. Consult the doctor who prescribed your child’s HUMIRA before getting any vaccination for your child.

How will I know if my child is allergic to HUMIRA?

Warning signs of a serious allergic reaction to HUMIRA may include hives, trouble breathing, and swelling of the face, eyes, lips, or mouth. If your child experiences any of these symptoms, call your child's prescribing doctor or seek emergency care immediately.

Tell your child's doctor if he or she has any allergies to rubber or latex. The needle cover on the prefilled syringe contains dry natural rubber, which can trigger an allergic reaction.

Are there any foods that interact with HUMIRA?

Studies have not been done to see how HUMIRA interacts with food. If you have questions, talk to your child's doctor.

Who shouldn't use HUMIRA?

Your child should not use HUMIRA if he or she has an allergy to HUMIRA or to any of the ingredients in HUMIRA (including sodium phosphate, sodium citrate, citric acid, mannitol, and polysorbate 80). The needle cover on the prefilled syringe contains dry natural rubber. Tell your child’s doctor if he or she has any allergies to rubber or latex.

What are the possible side effects with HUMIRA?

Also, see What is the most important information I should know about 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 the face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with vision, weakness in the 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 the 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 the 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 the stomach (abdomen).
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your child's doctor or get medical care right away if your child develops 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 child's doctor if your child has any side effect that bothers him or her or that does not go away.

Remember, tell your child's doctor right away if your child has an infection or any signs 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 child's body
  • Diarrhea or stomach pain
  • Burning when your child urinates
  • Urinating more often than normal
  • Feeling very tired

See more Important Safety Information for HUMIRA

What are the common side effects of HUMIRA?

Common side effects of HUMIRA include:

  • Injection site reactions (redness, rash, swelling, itching, or bruising)
  • Upper respiratory infections (sinus infections)
  • Headaches
  • Rash
  • Nausea

These are not all of the possible side effects with HUMIRA. Tell the doctor if your child has any side effect that bothers him or her or that does not go away. Ask your child's doctor or pharmacist for more information.

How do I give my child a HUMIRA injection?

See the Patient Instructions for Use for the HUMIRA Pen or the prefilled syringe which comes with your child's HUMIRA.

Do not try to inject HUMIRA until you have been shown the right way to give the injections to your child. If your child's doctor decides that you are able to give the injections to your child at home, you should receive training on the right way to prepare and inject HUMIRA. Your child's first injection should be given under the supervision of a health care professional.

Check out our step-by-step instructional video about how to inject HUMIRA.

Here are some Tips for Creating a Positive Injection Environment you can try that may help the transition into your child’s injection routine.

Learn more about injecting HUMIRA from your HUMIRA Ambassador.

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

What should I do with the used Pens or syringes? Can I reuse the needle?

HUMIRA comes in single-use Pens and prefilled syringes. The needle is not removable or reusable.

You should always check with your child's health care provider for instructions on how to properly dispose of used Pens and syringes.

Here are some tips that you may find helpful:

Place your Pen or syringe in an FDA-cleared sharps disposal container right away after use and keep it out of the reach of children. DO NOT throw away (dispose of) the Pen or a syringe in household trash or recycle the sharps disposal container. Or use a household container made of heavy-duty plastic, able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out; upright and stable; leak-resistant; and properly labeled to warn of hazardous waste inside.

HUMIRA Ambassadors can arrange to send you sharps containers for used Pens and syringes and can help you enroll in the sharps disposal service, at no additional cost. Call 1.800.4HUMIRA to enroll in the Ambassador Program (select the option to speak with a nurse).

When the container is almost full, you will need to follow the community guidelines for the right way to dispose of the sharps container. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at http://www.fda.gov/safesharpsdisposal

Items used in preparation of your injection, such as gauze or cotton balls, may be placed in the trash, unless otherwise instructed by your doctor, nurse, or pharmacist. The dose tray and cover may be recycled.

How should I store my child's HUMIRA?

HUMIRA needs to be stored in a refrigerator (2°C-8°C/36°F-46°F) in its original container and protected from light until it's used. HUMIRA should never be put in the freezer or frozen. Do not use HUMIRA if frozen, even if it has been thawed. Refrigerated HUMIRA may be used until the expiration date printed on the Pen or prefilled syringe. If you need to take it with you, such as when you're traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. Care should be taken to avoid dropping or crushing the product as the prefilled syringe is glass.

Can I store HUMIRA at room temperature?

  • Yes, if needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days with protection from light
  • Never store HUMIRA in extreme cold or extreme heat, or in direct sunlight
  • Keep track of the date you removed HUMIRA from the refrigerator by marking it on the carton and dose tray in the space provided
  • Once taken out of the refrigerator for room temperature storage, HUMIRA must be used within 14 days even if it is put back in the refrigerator. If not used within 14 days, the HUMIRA should be discarded
  • For questions regarding HUMIRA call Abbvie Inc. at 1-800-633-9110

How can I travel with HUMIRA?

  • When traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days with protection from light
  • Bring only the amount of HUMIRA you will need and can use within 14 days
  • Keep track of the date you removed HUMIRA from the refrigerator by marking it on the dose tray in the space provided
  • Never store HUMIRA in extreme cold or extreme heat, or in direct sunlight
  • When flying, do not store HUMIRA in your checked baggage, take it in your carry-on bag as it's safe to go through airport security
  • Once you arrive, even if you put HUMIRA back in the refrigerator, you must still use it within 14 days of when you first removed from the refrigerator. If not used within 14 days, the HUMIRA should be discarded
  • For questions regarding HUMIRA call Abbvie Inc. at 1-800-633-9110

Should I inject HUMIRA at room temperature?

If more comfortable, take your HUMIRA Pen or prefilled syringe out of the refrigerator for 15-30 minutes before injecting to allow the liquid to reach room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Do not warm HUMIRA in any other way (for example, do not warm in a microwave or under hot water).

Next Page: Understanding Pediatric
Crohn's Disease

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).
  • 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 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


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.

1299985-1889709


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.