About SIMPONITM

SIMPONITM is the first once-monthly self-injectable anti–TNF therapy 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 SIMPONITM just once a month under the skin.

Just one dose of SIMPONITM, monthly works to relieve:

  • Pain, stiffness, and swelling of RA and PsA
  • Pain and stiffness of AS
  • Results may not be the same for everyone

Selected Important Safety Information

SIMPONI™ can lower your ability to fight infections. Serious and sometimes fatal events can occur. There have been reports of serious infections including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that have spread throughout the body. Other serious side effects include lymphoma or other cancers, hepatitis B, heart failure or nervous system problems. To learn more about these and other risks, please read the Important Safety Information and the Medication Guide, and talk with your doctor.

Key Points About SIMPONITM

  • While some people using SIMPONITM may experience symptom relief in one month, studies show that SIMPONITM relieves pain and stiffness in some people with moderate to severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis after 3 months. Results may not be the same for everyone. Talk to your doctor about your response to SIMPONITM
  • With SIMPONITM, only one injection is required each month. So you'll only need 12 injections of SIMPONITM a year, fewer than the 26 or 52 injections you'd need if you were taking another anti-TNF medication. While dosing frequency is important, there are other factors to consider. So talk to your doctor about treatment options and what might be right for you
  • SIMPONITM has been extensively studied in clinical trials with more than 2200 people with RA, PsA, and AS
  • With SimponiOneSM Support, you can get the tools and support that can help you succeed in managing your condition. For example:
    • SimponiOneSM Cost Support, assistance for those who have private insurance and meet eligibility requirements
    • Help with other sources of financial support for those who don't have insurance or enough coverage for their treatment

SimponiOneSM can refer you to a patient assistance program such as Johnson & Johnson Patient Assistance Foundation (www.JJPAF.org) or help identify other sources of financial support.

Guide to SIMPONI™

Learn more about the benefits of SIMPONITM, the first once-monthly treatment for moderate to severe active rheumatoid arthritis (RA), active psoriatic arthritis (PsA), and active ankylosing spondylitis (AS).

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

 
 
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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, 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. 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, 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 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, skin reaction at site of injection, high blood pressure, flu, and cold sores.

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.