• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use SIMPONI. Ask your doctor if you do not know if you have lived in an area where these infections are common.
• have or have had hepatitis B.
• use the medicine ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab) or RITUXAN (rituximab).

• For children and adults taking TNF-blocker medicines, including SIMPONI, the chances of getting cancer may increase.
• There have been cases of unusual cancers in children and teenage patients taking TNF-blocking agents.
• People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.
• Some people receiving medicines that are like SIMPONI, called TNF blockers, developed a rare type of cancer called hepatosplenic T cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6 mercaptopurine (6-MP).
• 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.
• You should see your doctor periodically for skin examinations, especially if you have a history of skin cancer.

• with the medicine methotrexate to treat moderately to severely active rheumatoid arthritis (RA)
• to treat active psoriatic arthritis (PsA) alone or with methotrexate
• to treat active ankylosing spondylitis (AS)
• with moderately to severely active ulcerative colitis (UC) when certain other UC medicines have not worked well enough orcannot be tolerated, orif 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.

You may continue to use other medicines that help treat your condition while taking SIMPONI, such as non-steroidal anti-inflammatory drugs (NSAIDs) and prescription steroids, as recommended by your doctor.

It is not known if SIMPONI is safe and effective in children under 18 years of age.

• have an infection.
• have or have had lymphoma or any other type of cancer.
• have or had heart failure.
• have or have had a condition that affects your nervous system, such as multiple sclerosis or Guillain-Barré syndrome.
• have recently received or are scheduled to receive a vaccine. People taking SIMPONI should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer). People taking SIMPONI can receive non-live vaccines.
• have a baby and you were using SIMPONI during your pregnancy. Tell your baby's doctor before your baby receives any vaccine. Your baby may have an increased chance of getting an infection for up to 6 months after birth.
• are allergic to rubber or latex. The needle cover on the prefilled syringe and SmartJect autoinjector contains dry natural rubber.
• are pregnant or planning to become pregnant. It is not known if SIMPONI will harm your unborn baby.
• are breastfeeding or plan to breastfeed. You and your doctor should decide if you will take SIMPONI or breastfeed.

• use ORENCIA (abatacept) or KINERET (anakinra). You should not take SIMPONI while you are also taking ORENCIA (abatacept) or KINERET (anakinra).
• use other TNF-blocker medicines, including REMICADE (infliximab), HUMIRA (adalimumab), ENBREL (etanercept), or CIMZIA (certolizumab pegol).
• receive RITUXAN (rituximab) or ACTEMRA (tocilizumab).

Ask your doctor if you are not sure if your medicine is one listed above.
Keep a list of all your medicines with you to show your doctor and pharmacist each time you get a new medicine.

• SIMPONI is given as an injection under the skin (subcutaneous injection).
• If your doctor decides that you or a caregiver may be able to give your injections of SIMPONI at home, you should receive training on the right way to prepare and inject SIMPONI. Do not try to inject SIMPONI yourself until you have been shown the right way to give the injections by your doctor or nurse.
• Use SIMPONI exactly as prescribed by your doctor. Your doctor will tell you how much SIMPONI to inject and when to inject it depending on your medical condition.
• SIMPONI comes in a prefilled syringe or SmartJect autoinjector. Your doctor will prescribe the type that is best for you.
• See the detailed Instructions for Usethat comes with your SIMPONI for information about the right way to prepare and give your SIMPONI injections at home.
• Do not miss any doses of SIMPONI. If you forget to use SIMPONI, inject your dose as soon as you remember. Then, take your next dose at your regular scheduled time. In case you are not sure when to inject SIMPONI, call your doctor or pharmacist.

Psoriasis. Some people using SIMPONI had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with SIMPONI.

These are not all of the possible side effects of SIMPONI. Tell your doctor about any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store SIMPONI?

• Refrigerate SIMPONI at 36°F to 46°F (2°C to 8°C).
• If needed, you may store SIMPONI at room temperature up to 77°F (25°C) for one period of time up to 30 days.
  • Write the date of that you remove SIMPONI from the refrigerator on the carton.
  • If SIMPONI has reached room temperature, do notput it back in the refrigerator.
  • Throw away SIMPONI if it has been kept at room temperature for 30 days and has not been used.
• Do notfreeze SIMPONI.
• Keep SIMPONI in the original carton to protect it from light when not being used.
• Do notshake SIMPONI.
• Do not use SIMPONI after the expiration date on the carton or on the prefilled syringe or SmartJect autoinjector.

Keep SIMPONI and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SIMPONI for a condition for which it was not prescribed. Do not give SIMPONI to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about SIMPONI. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SIMPONI that is written for health professionals. For more information go to www.simponi.com or call 1-800-JANSSEN (1-800-526-7736).