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

What is adalimumab (Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package)?

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 purposes not listed in this medication guide.

What are the possible side effects of adalimumab (Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package)?

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.

• fever, night sweats, weight loss, tiredness;
• feeling full after eating only a small amount;
• pain in your upper stomach that may spread to your shoulder;
• easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Stop using adalimumab and call your doctor at once if you have any of these other serious side effects:

• signs of infection (fever, chills, sore throat, vomiting, diarrhea, flu symptoms);
• shortness of breath with swelling of your ankles or feet;
• confusion, neck stiffness, seizure (convulsions);
• pain or burning when you urinate;
• chest pain, ongoing cough, coughing up mucus or blood;
• numbness or tingly feeling, weakness in your legs;
• 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about adalimumab (Humira, Humira Pen, Humira Pen Crohn's Disease Starter Package)?

Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Adalimumab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. 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, cough, or flu symptoms.

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

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.

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