Adalimumab

(a da LIM yoo mab)

Dosage Forms

• This medicine is available as an injection.

Pharmacologic Category

• Antirheumatic, Disease Modifying
• Gastrointestinal Agent, Miscellaneous
• Monoclonal Antibody
• Tumor Necrosis Factor (TNF) Blocking Agent

What key warnings should I know about before giving this medicine to my child?

• Tuberculosis has been seen in patients started on adalimumab. These patients were exposed to tuberculosis in the past, but never had the infection. Your child should be tested to see if he/she has been exposed to tuberculosis.
• This medicine may increase your child's risk of developing lymphoma.
• Serious infections have occurred in patients who take these types of medicines. Talk with healthcare provider.
• This medicine does not mix well with many medicines. Serious reactions may occur. Check all medicines with child's healthcare provider.
• Please read the medication guide.

Is it safe for my child to take this medicine?

• Not if your child has an allergy to adalimumab or any other part of this medicine.
• Be sure to let healthcare provider know if your child has any allergies or reactions to medicine, food preservatives, or dyes. Make sure to tell about the allergy and how it affected your child. This includes telling about rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other symptoms involved.
• Not if your child has an infection.
• If your child has a latex allergy, talk with healthcare provider.

Why does my child need this medicine?

• This medicine is used to treat arthritis. The arthritis is usually considered moderately to severely active and may not have responded to other treatments.

How does this medicine work?

• Adalimumab is an arthritis-changing medicine. It reduces inflammation and helps reduce symptoms and protect joints from further harm.
• It reduces inflammation.
• It decreases the body's harmful response to diseases affecting the immune system.
• It reduces gastrointestinal inflammation and helps reduce symptoms.

How is this medicine given?

• This medicine is given as a shot into the fatty part of the skin.
• Your child's healthcare provider will teach you how to give the shot.
• Wash hands before and after use.
• Follow instructions closely if you are giving the shot at home.
• Throw syringe away after single use. Do not reuse.
• Throw away needles in needle/sharp disposal box and return box to healthcare provider when full.

How long does this medicine take to work?

• It may take several months to see the full effect.

What do I do if my child misses a dose? (does not apply to patients in the hospital)

• Give a missed dose as soon as possible.
• If it is almost time for the next dose, skip the missed dose and return to your child's regular schedule.
• Do not give a double dose or extra doses.
• Do not change dose or stop your child's medicine. Talk with healthcare provider.

What safety measures should I take while my child is using this medicine?

• Talk with healthcare provider before your child receives any vaccinations. Use with this medicine may either increase the risk of serious infection or make the vaccination less effective.
• Hepatitis B testing may be suggested. Unrecognized hepatitis B infection may worsen during treatment.
• Long-term use may increase your child's risk of cancer.
• Serious infections have been reported with use of this medicine. If your child has any infection, has many infections, or is taking antibiotics, talk with healthcare provider.
• Check your child's medicines with healthcare provider. This medicine may not mix well with other medicines.
• If your child has diabetes, talk with healthcare provider. Your child may be more likely to develop infections.

What are some possible side effects of this medicine?

• Risk of infection. Avoid people with infections, colds, or flu.
• Headache.
• Flu-like symptoms. These include headache, weakness, fever, shakes, aches, pains, and sweating. Your child may be given medicine before this shot to prevent these symptoms.
• Irritation where the shot is given.

What should I monitor?

• Change in condition being treated. Is it better, worse, or about the same?
• For the occurrence of side effects.
• Follow up with healthcare provider.

When should I call my child's healthcare provider?

• If any of this information causes you to be concerned, any of the common side effects occur, or if your child's symptoms do not improve after taking this medicine.
• If you suspect an overdose, call your local poison control center or emergency department immediately.
• If your child shows signs of a life-threatening reaction, call healthcare provider or emergency department immediately. These include wheezing; chest tightness; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat; or if your child exhibits any other unusual behavior.
• If your child shows any signs or symptoms of infection. These include a fever of 100.5 degrees or higher, chills, severe sore throat, ear or sinus pain, cough, increased sputum or change in color, painful urination, mouth sores, wound that will not heal, or anal itching or pain.
• If your child has difficulty breathing.
• If your child has a severe headache.
• If your child develops a rash.
• No improvement in condition or if you believe your child's condition is worse.

How should I store and/or dispose of this medicine?

• Store in a refrigerator. Do not freeze.
• Protect from light.

General statements

• If your child has a life-threatening allergy, he/she should wear allergy identification at all times.
• This medicine is available by prescription only. If there are refills, contact your pharmacy. If no refills remain, you may need to contact your child's healthcare provider.
• This medicine should be thrown out when your child no longer needs it or if the medicine becomes outdated.
• Most medicines can be thrown away in household trash after mixing with coffee grounds or kitty litter and sealing in a plastic bag.
• Do not share your child's medicine with others and do not give anyone else's medicine to your child.
• Keep all medicine out of the reach of children and pets.
• Many medications interact with other medications. Keep a list of all your child's medicines (prescription, natural products, supplements, vitamins, over-the-counter) with you. Give this list to your child's healthcare provider (doctor, nurse, nurse practitioner, pharmacist, physician assistant).
• Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or in Canada to Health Canada's Canada Vigilance Program at 1-866-234-2345.
• Talk with your child's healthcare provider before giving him/her any new medicine, including over-the-counter, natural products, or vitamins.
• Medicine can be dangerous if used incorrectly. Follow directions given by healthcare provider.

Copyright © 1978- Lexi-Comp Inc., The Children's Hospital, Denver, CO., and Pediatric Pharmacy Advocacy Group, Inc. All Rights Reserved. This information is protected under US and international copyright law. Unauthorized use or reproduction is prohibited.