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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

• 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

• 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

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).