Frequently Asked Questions About HUMIRA and JIA
HUMIRA is used in children 4 years of age and older to reduce signs and symptoms of moderate to severe polyarticular JIA. HUMIRA can be used alone or with methotrexate or with certain other medicines.
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.
HUMIRA may increase the chance of getting lymphoma or other cancers.
There have been cases of unusual cancers in children and teenagers using TNF-blocker medicines.
HUMIRA can cause serious side effects including allergic reactions, hepatitis B virus reactivation, nervous system problems, blood problems, heart failure, certain immune reactions (including a lupus-like syndrome), and new or worsening psoriasis.
Please click here for additional Important Safety Information you should know about HUMIRA and discuss it with your doctor.
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.
- 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, and monitor your child closely for signs and symptoms of TB during treatment with HUMIRA. If your child's doctor feels your child is at risk, your child may be treated with medicine for TB.
- Certain types of Cancer. There have been cases of unusual cancers in children and teenagers using TNF-blocker medicines. For children and adults taking TNF-blocker medicines, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some patients have developed non-melanoma skin cancer; tell your child's doctor if your child has a bump or open sore that doesn’t heal.
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 of an allergic reaction to HUMIRA 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?
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 include cough, low-grade fever, weight loss, or loss of body fat and muscle.
- Allergic reactions. Signs of a serious allergic reaction include skin rash, a swollen face, or trouble breathing.
- Hepatitis B virus reactivation in patients that carry the virus in their blood. Symptoms include feeling unwell, poor appetite, tiredness, fever, rash, or joint pain.
- 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.
- New heart failure or worsening of heart failure you already have. Symptoms include shortness of breath or swelling of your 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 rash on your cheeks or arms that gets worse in the sun.
- 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.
Certain types of cancer. There have been cases of unusual cancers in children and teenage patients using TNF-blocking agents. For children and adults taking TNF-blocker medicines, including HUMIRA, the chances of getting lymphoma or other cancers may increase. Some patients receiving HUMIRA have developed types of cancer called non-melanoma skin cancer. Tell your doctor if you have a bump or open sore that doesn’t heal.
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, call your child's doctor right away if your child has an infection or any signs of an infection, including:
- A fever
- Feeling very tired
- A cough
- Flu-like symptoms
- Warm, red, or painful skin
- Open cuts or sores on the body
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, have your child take their 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.
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to view Medication Guide and discuss it with your doctor.
Click here for Uses and Important Safety Information you should know about HUMIRA, and discuss it with your doctor.