After you and your child’s doctor have discussed HUMIRA, here are some things you should know. The goals of pediatric Crohn's disease management include achieving remission (few or no symptoms) and maintaining remission. HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in children 6 years of age and older with moderate to severe Crohn’s disease when certain other treatments have not worked well enough.
In addition, HUMIRA Ambassadors are available to provide support and guidance for you and your child throughout the duration of his or her treatment.
You know your child. When you feel that he or she is ready, you may want to include your child in discussions with the doctor about his or her condition and treatment. Remember to ask if he or she understands what the doctor has said.
Talking about and sharing this decision may help your child realize the importance of following treatment as directed by his or her doctor, and may give your child a better understanding of his or her condition.
Many people with immune-mediated inflammatory diseases such as Crohn's disease produce too much tumor necrosis factor (TNF). TNF is a protein that is found in your body and is part of your immune system. However, in patients with Crohn's disease, this overproduction of TNF can cause inflammation in the digestive or gastrointestinal (GI) tract, which can contribute to Crohn's symptoms.
HUMIRA belongs to a class of biologic medicines known as TNF blockers. Overproduction of TNF in the GI tract is associated with Crohn's disease. HUMIRA specifically binds to TNF to block its action. This helps reduce the inflammation that can lead to Crohn's symptoms.How HUMIRA Works
It's understandable that you may have some questions about starting your child on a new treatment. That's why we want to provide you with the information and support you need as your child starts HUMIRA.
One resource at your disposal is your HUMIRA Ambassador, who has received in-depth training on pediatric Crohn's disease and HUMIRA, available to you at no additional cost. Your HUMIRA Ambassador will work with you and your child during the onboarding process as well as provide education and support throughout your child’s treatment. They are available to answer questions about injecting HUMIRA, and they can also arrange for in-home injection training from a local registered nurse. HUMIRA Ambassadors do not give medical advice and will direct you to your child's health care professional for any treatment-related questions, including further referrals.
If the doctor decides that you are able to give your child injections at home, you should receive training by a health care professional on the right way to prepare and inject HUMIRA. Do not try to inject HUMIRA until you have been shown the right way to give the injections. The doctor will take your child's weight into consideration when deciding the appropriate dose. Your child’s first injection must be given under the supervision of a health care professional. Remember to keep your HUMIRA refrigerated in its original container until ready for use.
With HUMIRA, you may not have to make an appointment and travel to the doctor’s office for every dose. HUMIRA offers you the flexibility to administer your child’s medicine in the comfort of your home. Your child’s doctor will follow up with you on a regular basis. Refer to the Patient Instructions for Use for the HUMIRA Pen or the prefilled syringe and the Medication Guide for more information on the right way to inject HUMIRA.
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 he or she is experiencing any side effect that is bothersome or that does not go away.
We also want to provide additional information that may help you become more familiar with giving your child his or her injection. Here are some Tips for Creating a Positive Injection Environment when giving an injection.
Important: You must pay attention to your child’s starting dose—it is different than his or her maintenance dose and is a critical part of taking HUMIRA as prescribed. The doctor will take your child's weight into consideration when deciding the appropriate dose. Your child’s first injection must be given under the supervision of a health care professional. Remember to keep HUMIRA refrigerated in its original container until ready for use.
* 80 mg dose is given as 2 injections in one day.
† If your child weighs 88 lbs or more, the first dose (160 mg) can be administered as 4 injections in one day or as 2 injections per day for 2 consecutive days.
‡ HUMIRA is also available in 40 mg prefilled Pens.
HUMIRA has not been studied in pediatric patients with Crohn’s disease less than 6 years old.
You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your 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 doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA, even if your TB test was negative. If your doctor feels you are at risk, you 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, your 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 doctor if you have a bump or open sore that doesn’t heal.
Tell your doctor about all of your health conditions, including if you:
Also tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).
HUMIRA can cause serious side effects, including:
Call your doctor or get medical care right away if you develop 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 doctor if you have any side effect that bothers you or that does not go away.
HUMIRA is given by injection under the skin.
HUMIRA is a prescription medicine used:
HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in children 6 years of age and older with moderate to severe Crohn’s disease when certain other treatments have not worked well enough.
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. HUMIRA may increase the chance of getting lymphoma, including a rare kind, or other cancers. HUMIRA can cause serious side effects including hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, heart failure, certain immune reactions including a lupus-like syndrome, liver problems, and new or worsening psoriasis.