Important Safety Information About HUMIRA^® (adalimumab)

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

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF-blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection.

• Serious infections have happened in patients taking HUMIRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before starting HUMIRA, and monitor you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB.
• Certain types of Cancer. There have been cases of unusual cancers in children and teenagers using TNF-blocker medicines. For children and adults taking TNF-blocker medicines, including HUMIRA, the chance of getting lymphoma or other cancers may increase. Some patients have developed non-melanoma skin cancer; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor about all of your health conditions, including if you:

Have an infection, are being treated for infection, or have signs of an infection Get a lot of infections or have infections that keep coming back Have any open cuts or sores on your body Have diabetes Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis

Have or have had hepatitis B Are scheduled for major surgery Have numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome Have heart failure or other heart conditions Have recently received or are scheduled to receive a vaccine. Patients receiving HUMIRA should not receive live vaccines Are allergic to rubber or latex, or any ingredients of HUMIRA Are pregnant, planning to become pregnant, or breastfeeding

Also tell your doctor about all the medicines you take, especially Kineret (anakinra). Some medicines that suppress the immune system may increase your risk of serious infections.

What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

• Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include cough, low-grade fever, weight loss, or loss of body fat and muscle.
• Allergic reactions. Signs of a serious allergic reaction include skin rash, a swollen face, or trouble breathing.
• Hepatitis B virus reactivation in patients that carry the virus in their blood. Symptoms include feeling unwell, poor appetite, tiredness, fever, rash, or joint pain.
• Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
• Blood problems. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
• New heart failure or worsening of heart failure you already have. Symptoms include shortness of breath or swelling of your ankles or feet, or sudden weight gain.
• Immune reactions including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
• Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, call your doctor right away if you have an infection or any signs of an infection, including:

A fever Feeling very tired

A cough Flu-like symptoms

Warm, red, or painful skin Open cuts or sores on your body

This is the most important information to know about HUMIRA. For more information, talk to your health care provider.