Please read the Medication Guide for REMICADE® and discuss with your doctor.

Psoriatic Arthritis and REMICADE

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How REMICADE can provide rapid symptom relief and help stop further joint damage

Psoriatic arthritis can be difficult to manage because it involves both joint and skin symptoms, and they may not always develop together. Sometimes people with psoriatic arthritis may be so concerned with treating skin symptoms that they may simply tolerate joint pain when it occurs. They may never make the connection between the two sets of symptoms.

REMICADE has been approved for reducing the signs and symptoms of active psoriatic arthritis, as well as helping to stop the progression of joint damage. REMICADE can also help improve your ability to perform your daily routine, such as, getting out of bed, dressing, opening a jar, or turning a doorknob. This means tasks may become simple again.

Discover the strength of REMICADE for rapid, sustained relief of active psoriatic arthritis.

If you have been diagnosed with psoriatic arthritis, REMICADE may be able to help.

With rapid control of the inflammation process, REMICADE can relieve psoriatic arthritis symptoms in as little as two weeks. Individual results may vary.
REMICADE is strong enough to give you significant improvement of joint pain, swelling, and stiffness. REMICADE can also provide significant improvement of swollen fingers or toes and inflamed tendons or ligaments where they attach to the bone.
REMICADE can help stop further joint damage caused by psoriatic arthritis.
REMICADE can also relieve psoriatic skin symptoms so you have significantly greater skin clearance. Individual results may vary.
REMICADE can help improve physical function, which means you can get back to doing the things you enjoy.
REMICADE provides customized (based on your body weight), infrequent dosing. REMICADE is given as a two-hour IV infusion by a healthcare professional. You may need REMICADE only once every eight weeks. That could be as few as six times a year.
REMICADE has been used to treat more than one million people worldwide with conditions such as ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and rheumatoid arthritis.
REMICADE is covered by most major insurance plans, including Medicare and Medicaid. Coverage policies may vary by insurer or even between plans offered by the same insurer. If you have any questions about insurance coverage or reimbursement, you should first call your insurance company or Medicare. If you have questions or concerns, or if you need additional information related to medical coverage for REMICADE, you may call AccessOne^® at 1-888-ACCESS-1 (222-3771) for free assistance.

For further information about studies involving REMICADE, please visit the following resource:

REMICADE Clinical Studies

IMPORTANT SAFETY INFORMATION

Only your doctor can recommend a course of treatment after checking your health condition. REMICADE^® (infliximab) can cause serious side effects such as lowering your ability to fight infections. There are reports of serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor should monitor you closely for signs and symptoms of TB during treatment with REMICADE^®.
Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. A rare form of fatal lymphoma has occurred mostly in teenage or young adult males with Crohn's disease or ulcerative colitis who were taking REMICADE^® and azathioprine or 6-mercaptopurine. For children and adults taking TNF blockers, including REMICADE^®, the chances of getting lymphoma or other cancers may increase. You should discuss any concerns about your health and medical care with your doctor.

What should I tell my doctor before I take REMICADE^®?

You should let your doctor know if you have or ever had any of the following:

Tuberculosis (TB) or have been near someone who has TB. Your doctor will check you for TB with a skin test. If you have latent (inactive) TB, you will begin TB treatment before you start REMICADE^®.
Lived in a region where certain fungal infections such as histoplasmosis or coccidioidomycosis are common.
Infections that keep coming back, have diabetes or an immune system problem.
Any type of cancer or a risk factor for developing cancer, for example, chronic obstructive pulmonary disease (COPD) or had phototherapy for psoriasis.
Heart failure or any heart condition. Many people with heart failure should not take REMICADE^®.
Hepatitis B virus (HBV) infection or think you may be a carrier of HBV.
Nervous system disorders (such as multiple sclerosis or Guillain-Barré syndrome).

Also tell your doctor about any medications you are taking, including vaccines or Kineret (anakinra), and if you are pregnant, plan to become pregnant or are nursing. Adults and children should not receive a live vaccine while REMICADE^®.

What should I watch for and talk to my doctor about before or while taking REMICADE^®?

The following serious (sometimes fatal) side effects have been reported in people taking REMICADE^®.

You should tell your doctor right away if you have any of the signs listed below:

Infections (such as TB, blood infections, pneumonia)—fever, tiredness, cough, flu, or warm, red or painful skin or any open sores. REMICADE^® can make you more likely to get an infection or make any infection that you have worse.
Lymphoma, or any other cancers in adults and children.
Heart failure—new or worsening symptoms, such as shortness of breath, swelling of your ankles or feet, or sudden weight gain.
Reactivation of HBV—feeling unwell, poor appetite, tiredness, fever, skin rash and/or joint pain.
Liver injury—jaundice (yellow skin and eyes), dark brown urine, right-sided abdominal pain, fever, or severe tiredness.
Blood disorders—fever that doesn't go away, bruising, bleeding or severe paleness.
Nervous system disorders—numbness, weakness, tingling, changes in your vision or seizures.
Allergic reactions during or after the infusion—hives, difficulty breathing, chest pain, high or low blood pressure, swelling of face and hands, and fever or chills.
Lupus-like syndrome—chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun. The more common side effects with REMICADE^® are respiratory infections (that may include sinus infections and sore throat), headache, rash, coughing and stomach pain.
Psoriasis—new or worsening psoriasis such as red scaly patches or raised bumps on the skin that are filled with pus.

Medication Guide for REMICADE^®

Please read the Medication Guide for REMICADE^® and discuss it with your doctor.
(Requires Adobe^® Reader^®. Click here to download.)

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.

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Last Updated: January 19, 2009