Frequently Asked Questions About HUMIRA

Yes, HUMIRA Citrate-free is the same HUMIRA you've come to count on with less pain immediately following injection.*

The active ingredient (adalimumab) is the same as it has been for over 15 years, with the same results of HUMIRA you've come to count on.

Learn more about HUMIRA Citrate-free for Juvenile Idiopathic Arthritis.

*Compared to HUMIRA 40 mg/0.8 mL.

Yes. HUMIRA Without Citrate Buffers and HUMIRA Citrate-free are names referring to the same HUMIRA presentation.

HUMIRA Citrate-free comes in several different packages. Look for the 29-gauge needle call-out and updated liquid volume on the package, and let your specialty pharmacy know if you have any questions or concerns about the HUMIRA you receive.

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.

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:

• 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 of HUMIRA original presentation contains natural rubber latex, which can trigger an allergic reaction.

The black needle cover for both the HUMIRA Citrate-free Pen and prefilled syringe is not made with natural rubber latex.

Learn more about HUMIRA Citrate-free for Juvenile Idiopathic Arthritis.

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 of HUMIRA original presentation contains natural rubber latex. Tell your child's doctor if he or she has any allergies to rubber or latex.

The black needle cover for both the HUMIRA Citrate-free Pen and prefilled syringe is not made with natural rubber latex.

Learn more about HUMIRA Citrate-free for Juvenile Idiopathic Arthritis.

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). These problems can lead to liver failure and death.
• 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 (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:

• 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 (pain, 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, located inside your HUMIRA carton, and within the Full Prescribing Information.

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).