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Brand Names: Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package

Generic Name: adalimumab (Pronunciation: ay da LIM yoo mab)

• What is adalimumab (Humira)?
• What are the possible side effects of adalimumab (Humira)?
• What is the most important information I should know about adalimumab (Humira)?
• What should I discuss with my healthcare provider before using adalimumab (Humira)?
• How should I use adalimumab (Humira)?
• What happens if I miss a dose (Humira)?
• What happens if I overdose (Humira)?
• What should I avoid while using adalimumab (Humira)?
• What other drugs will affect adalimumab (Humira)?
• Where can I get more information?

What is adalimumab (Humira)?

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 are the possible side effects of adalimumab (Humira)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Serious and sometimes fatal infections may occur during treatment with adalimumab. Stop using adalimumab and call your doctor right away if you have signs of infection such as:

• fever, sweating, chills, tired feeling;
• feeling short of breath;
• cough, sore throat; or
• flu symptoms, weight loss.

Call your doctor at once if you have any of these other serious side effects:

• shortness of breath with swelling of your ankles or feet;
• confusion, seizure (convulsions);
• pain or burning when you urinate;
• chest pain, ongoing cough, coughing up blood;
• easy bruising or bleeding, pale skin, unusual weakness;
• numbness or tingly feeling, weakness in your legs;
• jaundice (yellowing of the skin or eyes);
• red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores;
• joint pain or swelling with fever, swollen glands, muscle aches, vomiting, unusual thoughts or behavior, and/or seizure (convulsions); or
• patchy skin color, red spots, or a butterfly-shaped skin rash over your cheeks and nose (worsens in sunlight).

Less serious side effects may include:

• headache;
• stuffy nose, sinus pain;
• nausea, stomach pain; or
• pain, redness, itching, swelling, or bleeding where you injected the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

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 such as lymphoma (cancer of the lymph nodes) or autoimmune disorders (such as a lupus-like syndrome). This risk may be greater in children and young adults. 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, cough, sweating, tired feeling, or feeling short of breath.

Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.

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