About SIMPONI®

And Other Types of Treatment

What kinds of medicines are used to treat moderate to severe RA, active PsA, or active AS?

Rheumatoid diseases cause pain, stiffness, and swelling. They affect joints, tendons, ligaments, bones, and muscles, and some rheumatoid diseases can also affect internal organs.

There are many kinds of treatments that can help people living with rheumatoid diseases, including:

NSAIDs

Doctors often prescribe nonsteroidal anti-inflammatory drugs (NSAIDs) when rheumatoid arthritis (RA), psoriatic arthritis (PsA), or ankylosing spondylitis (AS) first starts, which can help relieve pain, stiffness, and swelling. You can buy NSAIDs like Motrin®*, Advil®*, and Aleve®* at the drugstore without a prescription, or your doctor may prescribe others, like Celebrex®*. But many people find that, as time goes by, they will need a medicine stronger than NSAIDs to relieve their symptoms.

DMARDs

Your doctor may have prescribed a drug called a DMARD (disease-modifying antirheumatic drug) to help treat your condition. Methotrexate is a DMARD that doctors commonly prescribe for RA, and sometimes for people with PsA. Many people feel better when they take methotrexate, but for some people, methotrexate isn’t enough. So sometimes your doctor will combine methotrexate with other medications to give you more relief from your symptoms.

Doctors have found that when methotrexate is combined with a biologic therapy, the two drugs working together can be very helpful in controlling symptoms of RA and PsA.

BIOLOGIC THERAPY

Like NSAIDs and DMARDs, biologics help treat moderate to severe RA, active PsA, and/or active AS by helping to reduce the pain and inflammation caused by these diseases.

SIMPONI® is a biologic therapy. It blocks the action of a protein in your body called tumor necrosis factor-alpha (TNF-alpha). TNF-alpha is made by your body’s immune system. People with certain diseases have too much TNF-alpha, which can cause the immune system to attack parts of the body. SIMPONI® can block the effects of too much TNF-alpha.

SIMPONI® is the only self-injectable biologic therapy for RA, PsA, and AS that requires just one injection a month.

Please read the Important Safety Information for SIMPONI® and the Medication Guide below and discuss any questions you have with your doctor.

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Important Safety Information

SIMPONI® (golimumab) is the first once-monthly self-injectable biologic treatment for adults with:

  • moderate to severe rheumatoid arthritis (RA), with the medicine methotrexate
  • active psoriatic arthritis (PsA), alone or with the medicine methotrexate
  • active ankylosing spondylitis (AS)

Methotrexate is used as directed.

Once you and your doctor are comfortable with the self-injection process, you will inject SIMPONI® just once a month under the skin.

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), ACTEMRA (tocilizumab), 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 should 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
  • dark urine
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • clay-colored bowel movements
  • fevers
  • chills
  • stomach discomfort
  • skin rash

Heart failure can occur or get worse in people who use TNF blockers, including 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, including SIMPONI®, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. 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.

Serious liver problems can happen in people using TNF blockers, including SIMPONI®. 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, including SIMPONI®. 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 pregnant, planning to become pregnant or are breastfeeding or have a baby and were using SIMPONI® during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

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. Some reactions can be serious and life-threatening.

Common side effects of SIMPONI® include: upper respiratory tract infection, reaction at site of injection, and viral infections.

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.

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