HUMIRA^®: A Biologic Medication to Treat Moderate to Severe Crohn's Disease

Important Safety Information You Should Know About HUMIRA^® (adalimumab)

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.

Before starting HUMIRA:
You should not start taking HUMIRA if you have any kind of infection. Tell your doctor if you think you have an infection, are being treated for an infection, have signs of an infection (such as a fever, cough, or flu-like symptoms), have any open cuts or sores on your body, or get a lot of infections or have infections that keep coming back. Tell your doctor if you have diabetes, have TB or have been in close contact with someone with TB, were born in, lived in, or traveled to countries where there is more risk for getting TB, live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis), have or have had hepatitis B, use the medicine Kineret (anakinra), or are scheduled to have major surgery.

Tell your doctor if you have any 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, are pregnant, become pregnant, plan to become pregnant or are breastfeeding. Tell your doctor if you are allergic to HUMIRA or any of its ingredients or are allergic to rubber or latex. The needle cover of the prefilled syringe and the pen contain dry natural rubber.

Also, tell your doctor if you have recently received or are scheduled for any vaccines. Except for live vaccines, patients may still receive vaccines while on HUMIRA. It is recommended that children with juvenile idiopathic arthritis be brought up to date with all immunizations prior to starting HUMIRA.

After starting HUMIRA:
Call your doctor right away if you have an infection, or any sign of an infection, including a fever, feeling very tired, cough, flu-like symptoms, warm, red or painful skin, or if you have any open cuts or sores on your body. HUMIRA can make you more likely to get infections or make any infection that you may have worse.

Possible side effects of HUMIRA:
Serious side effects, which sometimes lead to death, have happened in patients taking HUMIRA.
Serious infections. These infections include TB and infections caused by viruses, fungi, or bacteria. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with HUMIRA and during treatment with HUMIRA. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking HUMIRA. Patients who had a negative TB skin test before receiving HUMIRA have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking HUMIRA: cough, low-grade fever, weight loss, or loss of body fat and muscle.
Certain types of cancer. There have been cases of certain kinds of cancer, in patients taking HUMIRA or other TNF blockers. Patients with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. Some patients receiving HUMIRA have developed types of cancer called non-melanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.
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. Tell your doctor if you have any of the following symptoms: feel unwell, poor appetite, fatigue, 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 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.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with HUMIRA may be stopped.

Common side effects of HUMIRA are: injection site reactions (redness, rash, swelling, itching or bruising), upper respiratory infections (sinus infections), headaches, rash and nausea.

These are not all the side effects with HUMIRA. Ask your doctor or pharmacist for more information.

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.

Please see the full prescribing information, including the Medication Guide, for HUMIRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

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