Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), and Ankylosing Spondylitis (AS)

SIMPONI™ and the Diseases It Treats:



SIMPONI™ Treats Rheumatoid Arthritis (RA)

SIMPONI™ is indicated for the treatment of adults with moderate to severe rheumatoid arthritis (RA) with the medicine methotrexate.

About Rheumatoid Arthritis (RA)

Today, almost 1.3 million American adults have rheumatoid arthritis (RA). It is a serious disease that causes pain and swelling (inflammation) in your joints. It can happen in any joint, but usually starts in the smaller joints of your fingers, hands, wrists, and feet. Usually, if you have it in one hand, you’ll have it in the other. The same is true for your feet, wrists, and other joints. Over time, RA can lead to joint damage, which causes more pain, and makes it hard to get around.

SIMPONI™ Treats Psoriatic Arthritis (PsA)

SIMPONI™ is indicated for the treatment of adults with active psoriatic arthritis (PsA), alone or with the medicine methotrexate.

About Psoriatic Arthritis (PsA)

Psoriatic arthritis (PsA) affects up to 30% of people with psoriasis, and occurs with equal frequency in both women and men. PsA is another rheumatoid disease that causes inflammation and pain in your joints. Unlike RA, PsA usually affects only the joints on one side of your body, not both at the same time. For most people, PsA starts with psoriasis, a skin disease that causes itchy patches of skin to appear on different areas of your body, before joint symptoms occur.

SIMPONI™ Treats Ankylosing Spondylitis (AS)

SIMPONI™ is indicated for the treatment of adults with active ankylosing spondylitis (AS)

About Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS) causes the joints in your spine and the joints between your spine and hip bones to become inflamed and painful. Other joints can also become inflamed, but usually the joints in your lower limbs are more commonly affected. AS usually begins in the young adult years, before the age of 35, and affects men three times more than women.

 

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SIMPONI™ is approved to treat adults with: 1.Moderately to severely active Rheumatoid Arthritis (RA) with the medicine methotrexate; 2. Psoriatic Arthritis (PsA) alone or in combination with the medicine methotrexate; 3. Active Ankylosing Spondylitis (AS)

IMPORTANT SAFETY INFORMATION

SIMPONI™ (golimumab) is a prescription medicine. SIMPONI™ can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI™ and will monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not start SIMPONI™ if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs of an infection such as:

  • fever, sweat, or chills
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • weight loss
  • warm, red, or painful skin
    or sores on your body
  • diarrhea or stomach pain
  • burning when you urinate
    or urinate more than normal
  • feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults taking TNF blockers, including SIMPONI™, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab) or another TNF blocker, or if you are scheduled to or recently received a vaccine. People taking SIMPONI™ should not receive live vaccines.

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are taking TNF-blocker medicines, such as SIMPONI™. Some of these cases have been fatal. Your doctor may do blood tests before and after you start treatment with SIMPONI™. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

  • feel very tired
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • dark urine
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • skin rash

Heart failure can occur or get worse in people who use TNF blockers like SIMPONI™. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath or swelling of your lower legs or feet.

Rarely, people using TNF blockers can have nervous system problems such as multiple sclerosis. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

Liver problems can happen in people using TNF blockers. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles, and/or legs.

New or worse psoriasis symptoms may occur. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus.

Tell your doctor if you are allergic to rubber or latex. The needle cover contains dry natural rubber.

Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI™ such as hives, swollen face, breathing trouble, chest pain.

Common side effects of SIMPONI™ include: upper respiratory tract infection, nausea, abnormal liver tests, redness at site of injection, high blood pressure, bronchitis, dizziness, sinus infection, flu, runny nose, fever, cold sores, numbness, or tingling.

Please read the Medication Guide for SIMPONI™ and discuss any questions you have with your doctor.

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.