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:

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:

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

Information You Should Know About HUMIRA^® (adalimumab)

HUMIRA is a medicine called a tumor necrosis factor (TNF) blocker. HUMIRA is taken by injection and is available by prescription only.

HUMIRA is used to:

• Reduce the signs and symptoms of:
  • moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone or with methotrexate or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 4 years of age and older. HUMIRA can be used alone or with methotrexate or with certain other medicines.
  • psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • ankylosing spondylitis (AS) in adults.
  • moderate to severe Crohn's disease (CD) in adults who have not responded well to conventional treatments. HUMIRA is also for these adults who have lost response to or are unable to tolerate infliximab.
• Treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in adults who are under the ongoing care of a physician, have the condition in many areas of their body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills). When considering HUMIRA, your physician will determine if other systemic therapies are medically less appropriate.