Frequently Asked Questions About HUMIRA^® and JIA

• What is the most important information I should know about HUMIRA?
• How does exposure to illnesses such as chicken pox affect my child?
• What should I do about my child's vaccination schedule?
• How will I know if my child is allergic to HUMIRA?
• How will HUMIRA affect the growth and development of my child?
• Are there any foods that interact with HUMIRA?
• Who shouldn't use HUMIRA?
• What are the possible side effects with HUMIRA?
• What are the common side effects with HUMIRA?
• How do I give my child a HUMIRA injection?
• Will I be able to reuse the syringe?
• How should I store my child's HUMIRA?

HUMIRA is used to reduce the signs and symptoms of moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone or with methotrexate or with certain other medicines.

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

HUMIRA is a medicine that affects your child’s immune system. HUMIRA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking HUMIRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your child’s doctor should test your child for TB before starting HUMIRA.
• Your child’s doctor should monitor your child closely for signs and symptoms of TB during treatment with HUMIRA.

Before starting HUMIRA, tell your child’s doctor if your child:

• may have an infection. Your child should not start taking HUMIRA if your child has any kind of infection.
• is being treated for an infection
• has signs of an infection, such as a fever, cough, or flu-like symptoms
• has any open cuts or sores on their body
• gets a lot of infections or has infections that keep coming back
• has diabetes
• has TB, or has been in close contact with someone with TB
• was born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your child’s doctor if you are not sure.
• lives or has lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). If you do not know if your child has lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your child’s doctor.
• has or had hepatitis B
• uses the medicine Kineret (anakinra). Your child may have a higher chance for serious infections and a low white blood cell count when taking HUMIRA with Kineret.
• is scheduled to have major surgery

After starting HUMIRA, call your child’s doctor right away if your child has an infection, or any sign of an infection, including:

• a fever
• feel very tired
• a cough
• flu-like symptoms
• warm, red, or painful skin
• open cuts or sores on your child's body

HUMIRA can make your child more likely to get infections or make any infection that your child may have worse.

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.

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

Warning signs may include a skin rash, swollen face, or difficulty breathing. 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/she has any allergies to rubber or latex. The needle cover on the pre-filled 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 a trial of 171 children ages 4 to 17 years old with polyarticular JIA for a period of up to 2 years. Currently there are not enough data to assess the effect of HUMIRA on growth, development, and maturation of a child. If you are concerned about these issues, talk with the child's physician who prescribed HUMIRA.

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/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 pre-filled syringe contains dry natural rubber. Tell your doctor if your child has any allergies to rubber or latex.

What are the possible side effects with HUMIRA?

Serious side effects, which sometimes lead to death, have happened in patients taking HUMIRA, including:

Serious Infections. See "What is the most important information I should know about HUMIRA?"

Your child’s doctor will examine your child for tuberculosis (TB) and perform a test to see if he or she has TB. If your child’s doctor feels that he or she is at risk for TB, your child may be treated with medicine for TB before beginning treatment with HUMIRA and during treatment with HUMIRA. Even if your child’s TB test is negative your child’s doctor should carefully monitor your child for TB infections while taking HUMIRA. Patients who had a negative TB skin test before receiving HUMIRA have developed active TB. Tell your child’s doctor if your child has any of the following symptoms while taking or after taking HUMIRA:

• cough that does not go away
• low grade fever
• weight loss
• loss of body fat and muscle (wasting)

• Certain types of Cancer.
  • There have been cases of certain kinds of cancer, in patients taking HUMIRA or other TNF blockers.
  • Some patients receiving HUMIRA have developed types of cancer called non-melanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life-threatening if treated. Tell your child’s doctor if your child has a bump or open sore that doesn't heal.
  • Patients with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• Allergic reactions. Signs of a serious allergic reaction include a skin rash, a swollen face, or trouble breathing.
• Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases patients have died as a result of hepatitis B virus being reactivated. Your child’s doctor should monitor your child carefully during treatment with HUMIRA if they carry the hepatitis B virus in their blood. Tell your child’s doctor if your child has any of the following symptoms:
  • feel unwell
  • poor appetite
  • tiredness (fatigue)
  • fever, skin rash, or joint pain
• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your child’s vision, weakness in your child’s arms or legs, and dizziness.
• Blood problems. Your child’s body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• New heart failure or worsening of heart failure your child already has. Symptoms include shortness of breath or swelling of your child’s ankles or feet or 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 a rash on your child’s cheeks or arms that gets worse in the sun. Symptoms may go away when you stop HUMIRA.

Call your child’s doctor or get medical care right away if your child develops any of the above symptoms. Your child’s treatment with HUMIRA may be stopped.

What are the common side effects with HUMIRA?

Common side effects with HUMIRA include:

• Injection site reaction such as redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. If your child has pain, redness or swelling around the injection site that doesn’t go away within a few days or gets worse, call your child’s doctor right away.
• Upper respiratory infection (including sinus infections)
• Headaches
• Rash
• Nausea

These are not all the possible side effects with HUMIRA. Tell your child’s doctor if your child has any side effect that bothers your child 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 section, "How do I prepare and give an injection of HUMIRA?" at the end of this Medication Guide for complete instructions for use.

• HUMIRA is given by an injection under the skin. Your child’s doctor will tell you how often to inject HUMIRA. Do not inject HUMIRA more often than prescribed.
• Make sure you have been shown how to inject HUMIRA before you do it to your child. You can call your child’s doctor or 1-800-4HUMIRA (448-6472) if you have any questions about giving your child an injection. Someone you know can also help you with your child’s injection.
• If your child takes more HUMIRA than you were told to take, call your child’s doctor right away.
• Do not miss any doses of HUMIRA. If your child forgets to take HUMIRA, inject a dose as soon as you remember. Then, take your child’s next dose at their regular scheduled time. This will put your child back on schedule. To help your child remember when to take HUMIRA, you can mark your calendar ahead of time with the stickers provided in the back of the Medication Guide.

Will I be able to reuse the syringe?

HUMIRA is available as a single-dose syringe or Pen and should NEVER be injected more than once.

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. Refrigerated HUMIRA remains stable until the expiration date printed on the pre-filled syringe or Pen. 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.

Click here to view Medication Guide and discuss it with your doctor.