Moderate to Severe Polyarticular
Juvenile Idiopathic Arthritis
Menu

Frequently Asked Questions
About HUMIRA

Whether your child has already started on HUMIRA or you are considering it, here 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, 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.

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.

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.

How will HUMIRA affect the growth and development of my child?

HUMIRA has been studied in clinical trials in patients with polyarticular JIA as young as 2 years old. Currently, there are not enough data to assess the effect of HUMIRA on the growth, development, and maturation of a child. If you are concerned about these issues, talk with your child's prescribing physician.

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 which comes with your child's HUMIRA.

Do not try to inject HUMIRA yourself 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 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 healthcare professional.

What should I do with the used Pen or syringe? Can I reuse the needle?

HUMIRA comes in single-use prefilled Pens or in 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. You should follow any special state or local laws regarding the proper disposal of Pens and syringes. DO NOT throw the Pen or syringe in the household trash or recycle.

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. DO NOT throw away (dispose of) pen or 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.

You can sign up to receive sharps containers for HUMIRA Pen or syringe disposal at no additional cost.

When the container is almost full, 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 the 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 prefilled syringe or Pen. 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 my child’s HUMIRA at room temperature?

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. HUMIRA should be discarded if not used within the 14-day period.

When not traveling, your child’s HUMIRA Pen or prefilled syringe should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton until you are ready to use it.

My child’s HUMIRA carton says that it “may be stored at room temperature.” What is considered room temperature?

Room temperature is up to 77°F (25°C). In addition, your child’s HUMIRA Pen or prefilled syringe should be protected from direct sunlight and stored in its original carton until you are ready to use it.

How long can I store my child’s HUMIRA Pen or prefilled syringe at room temperature?

Once you remove your child’s HUMIRA Pen or prefilled syringe from the refrigerator, it must be used within 14 days. If not used within the 14 days, it must be discarded.

Can I put my child’s HUMIRA Pen or prefilled syringe back in the refrigerator after I’ve already taken it out and allowed it to reach room temperature?

No. Once your child’s HUMIRA Pen or prefilled syringe has reached room temperature, it must be used within 14 days. HUMIRA that has reached room temperature must be discarded if it is not used within the 14-day period.

What should I do if I have not used my child’s unrefrigerated HUMIRA Pen or prefilled syringe within the 14-day period?

Do not use it and call your pharmacist immediately to let them know that your child’s HUMIRA Pen or prefilled syringe has been stored out of the refrigerator for more than 14 days. Your pharmacist will be able to advise you on how you may obtain a new HUMIRA Pen or prefilled syringe for your child.

Should I record the date when I take my child’s HUMIRA Pen or prefilled syringe out of the refrigerator?

Yes. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray.

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).

Has HUMIRA changed now that I can leave it at room temperature?

No, the formula of HUMIRA has not changed.

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. 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.

64H-1598805

In This Section

myHUMIRA:
Get answers, tools,
and assistance to
help throughout your
child's treatment plan.

Learn More

myHUMIRA offers:

Savings Card
On-Call Nurse Support
Injection Training Kit & More


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.

1299985-1737903

HUMIRA Use1

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 2 years of age and older.

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.