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What is the most important information I should know about adalimumab?

Before you start treatment with adalimumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Treatment with adalimumab may increase your risk of developing certain types of cancer or autoimmune disorders (such as a lupus-like syndrome). Talk with your doctor about your individual risk.

Adalimumab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.

Serious and sometimes fatal infections may occur during treatment with adalimumab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, easy bruising or bleeding, pale skin, or unusual weakness.

Do not receive a "live" vaccine while you are being treated with adalimumab.

What is adalimumab?

Adalimumab reduces the effects of a substance in the body that can cause inflammation.

Adalimumab is used to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. It is also used to treat Crohn's disease after other drugs have been tried without successful treatment of symptoms.

Adalimumab may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using adalimumab?

Do not use this medication if you are allergic to adalimumab, or if you are also being treated with anakinra (Kineret).

Before using adalimumab, tell your doctor if you are allergic to any drugs, or if you have:

• an active or recent infection;

• a history of tuberculosis;

• hepatitis B;

• congestive heart failure;

• lupus;

• an allergy to latex rubber;

• a disease that affects the nerves or muscles, such as multiple sclerosis, myasthenia gravis, Guillain-Barre syndrome; or

• if you are scheduled to have major surgery or receive any vaccines.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use adalimumab.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Your name may need to be listed on a Humira pregnancy registry when you start using this medication.

It is not known whether adalimumab passes into breast milk. Do not use adalimumab without first talking to your doctor if you are breast-feeding a baby.

Using this medication may increase your risk of certain types of cancer, such as breast, colon, prostate, or lung cancer, or melanoma (a tumor that usually affects the skin). You may also develop an autoimmune disorder such as a lupus-like syndrome. Talk with your doctor about your specific risk.