Adalimumab

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|Adalimumab

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Adalimumab


Generic Name: Adalimumab (ay-da-LIM-yoo-mab)
Brand Name: Humira

Adalimumab can decrease your immune system"s ability to fight infections. Adalimumab also has been shown to worsen tuberculosis (TB). Before beginning therapy with Adalimumab , you should have a TB skin test to check for TB that may not be causing any symptoms.


Adalimumab is used for:

Reducing signs and symptoms, preventing bone damage, and improving physical function in patients with moderate to severe rheumatoid arthritis who have not had a good response to other arthritis medicines. It can be used alone or with other medicines.

Adalimumab is a TNF (tumor necrosis factor)-blocker. It works by blocking a protein (TNF-alpha) found in the body"s immune system that causes joint swelling and damage.

Do NOT use Adalimumab if:

  • you are allergic to any ingredient in this medicine
  • you are taking other TNF-blockers (eg, etanercept, infliximab), anakinra, or live vaccines
  • you have a blood infection (sepsis)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Adalimumab :

Some medical conditions may interact with Adalimumab . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, plan to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have heart failure, an infection, an immune system disorder, nerve problems, a brain or spinal cord disorder, cancer, lupus, a latex allergy, or are scheduled for surgery

Some MEDICINES MAY INTERACT with Adalimumab . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anakinra or interleukin-1 because side effects, including increased risk of serious infections or decrease of white blood cells, may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Adalimumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Adalimumab :

Use Adalimumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Adalimumab is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Adalimumab at home, carefully follow the injection procedures taught to you by your health care provider. Ask any questions that you may have about Adalimumab or giving injections.
  • Adalimumab comes with an additional patient leaflet. Read it carefully and reread it each time you get Adalimumab refilled.
  • If Adalimumab contains particles or is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
  • Do not shake Adalimumab .
  • Rotate injection sites. New injections should be given at least 1 inch from an old site.
  • Do not inject into areas of the skin that are sore, bruised, red, or hard.
  • Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
  • If you miss a dose of Adalimumab , call your doctor or pharmacist to establish a new dosing schedule.

Ask your health care provider any questions you may have about how to use Adalimumab .

Important safety information:

  • Adalimumab may cause dizziness or vision changes. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Adalimumab .
  • Adalimumab may lower your body"s ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Adalimumab .
  • Check with your doctor before having vaccinations while you are using Adalimumab . Avoid contact with people who have recently received oral polio vaccine.
  • LAB TESTS, including TB tests and monitoring for infections, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Adalimumab with caution in the ELDERLY because they may be more sensitive to its side effects.
  • Adalimumab is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Adalimumab during pregnancy. It is unknown if Adalimumab is excreted in breast milk. Do not breast-feed while taking Adalimumab .

Possible side effects of Adalimumab :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; flaring; itching, pain, redness, or swelling at the injection site; sinus inflammation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine or stools; butterfly-shaped rash on the nose and cheeks; chest pain; chills; dark urine; dizziness; easy bruising/bleeding; fainting; fast, irregular, or pounding heartbeat; fever; headache; joint pain; leg pain or swelling; mental/mood changes; muscle weakness; night sweats; numbness, tingling, or pain in the hands or feet; painful or frequent urination; pale skin; persistent pain, swelling, or redness at the injection site; persistent sore throat or dry cough; stomach pain; swollen glands; unsteadiness; unusual fatigue; unusual lumps; unusual vaginal discharge; vision changes; weight loss; white patches in the mouth; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Adalimumab :

Store Adalimumab in the refrigerator between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from light. Store in the original container until ready to use. If you need to take Adalimumab with you, such as when traveling, store it in a cool carrier with an ice pack and protect it from light. Do not use after the expiration date on the dose tray label or prefilled syringe. Keep Adalimumab , as well as syringes and needles, out of the reach of children and away from pets.

General information:

  • If you have any questions about Adalimumab , please talk with your doctor, pharmacist, or other health care provider.
  • Adalimumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Adalimumab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006
Database Edition 06.4.1.002
Copyright © 2006 Wolters Kluwer Health, Inc.




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