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.
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. 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 the seasonal flu:
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 natural rubber latex, 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 natural rubber latex. Tell your child’s doctor if he or she has any allergies to rubber or latex.
HUMIRA can cause serious side effects, including:
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 (pain, 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:
Common side effects of HUMIRA include:
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.
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.
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.
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.
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.
Once your child’s HUMIRA Pen or prefilled syringe has reached room temperature, it must be used within 14 days even if it is put back in the refrigerator. HUMIRA that has reached room temperature must be discarded if it is not used 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.
Yes. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray.
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).
No, the formula of HUMIRA has not changed.