Simponi®

SIMPONI® Patient Support

Welcome to Janssen CarePath

Information you may need to help you get started and stay on track

Janssen CarePath is here to help answer your questions about treatment with SIMPONI®. Once your doctor has prescribed SIMPONI®, we will give you resources that may help you get started and stay on track.  We’ll also give you information about how to take this medication as your doctor prescribed, how to pay for it, and what questions you may want to ask your doctor and insurance plan.

Paying for SIMPONI®

If you have commercial or private health insurance and need help paying for SIMPONI®, the Janssen CarePath Savings Program may be able to help. If you don’t have commercial or private health insurance, you may find help from the programs and resources available from the Janssen Prescription Assistance Web site.

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Getting Started

Janssen CarePath provides the additional support you may need to help get started with SIMPONI® treatment. A personally assigned Janssen CarePath Care Coordinator will work closely with you and your doctor to help you get started.

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Staying on Track

Janssen CarePath offers additional support to help you stay on track with your SIMPONI® treatment as prescribed by your doctor.

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What is SIMPONI® (golimumab)?

SIMPONI® is a once-monthly self-injectable biologic treatment for adults with:

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

Methotrexate is used as directed.

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

SIMPONI® is used in adults with moderate to severe active ulcerative colitis (UC) when certain other UC medicines have not worked well enough or cannot be tolerated, or if it is necessary to continue taking steroid medicines:

  • to begin helping some of your symptoms
  • in people who respond to SIMPONI®, to get their UC under control (induce remission) and keep UC under control (sustain remission)
  • to begin to improve the way the lining of your large intestine looks to your doctor during colonoscopy

SIMPONI® is a self-injectable biologic treatment given every 4 weeks after 2 starter doses.

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

Important Safety Information For SIMPONI®

SERIOUS INFECTIONS

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. Hepatosplenic T-cell lymphoma, a rare and fatal lymphoma, has occurred mostly in teenage or young adult males with Crohn’s disease or ulcerative colitis who were taking other TNF blockers with azathioprine or 6-mercaptopurine. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI® have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI®, tell your doctor.

USE WITH OTHER DRUGS

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 or treatment with a weakened bacteria (such as BCG for bladder cancer).

HEPATITIS B INFECTION

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

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI®. If you develop new or worsening heart failure with SIMPONI®, you may need treatment in a hospital, and it may result in death. 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, swelling of your lower legs or feet, or sudden weight gain.

NERVOUS SYSTEM PROBLEMS

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.

IMMUNE SYSTEM PROBLEMS

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.

LIVER PROBLEMS

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.

BLOOD PROBLEMS

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.

OTHER CONSIDERATIONS TO TELL YOUR DOCTOR

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

ALLERGIC REACTIONS

Allergic reactions can happen in people who use TNF-blocker medicines, including SIMPONI®. Tell your doctor if you have any symptoms of an allergic reaction while taking SIMPONI® such as hives, swollen face, breathing trouble, or 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.

PSORIASIS

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

Please read the full Prescribing Information and 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.

042501-151027