SIMPONI® is a prescription medicine called a Tumor Necrosis Factor (TNF) blocker. SIMPONI® is used to treat:

  • adults with moderately to severely active rheumatoid arthritis (RA) with the medicine methotrexate
  • adults with active psoriatic arthritis (PsA) alone or with methotrexate
  • adults with active ankylosing spondylitis (AS)
  • adults and children weighing at least 33 pounds (15 kg) with moderately to severely active ulcerative colitis (UC)

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 in RA, PsA, and AS or weighing less than 33 pounds (15 kg) in pediatric ulcerative colitis.

Only your doctor can decide if SIMPONI® is right for you. SIMPONI® can cause serious side effects. Please read the Medication Guide for SIMPONI® and discuss any symptoms or questions with your doctor.

SIMPONI® (golimumab) can lower your ability to fight infections. Serious and sometimes fatal events may 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 possible serious side effects may include lymphoma, skin cancer, a rare and fatal cancer called hepatosplenic T-cell lymphoma, other cancers, hepatitis B, heart failure, nervous system problems, immune system problems (lupus-like syndrome), liver problems, blood problems, or allergic reactions. To learn more about these and other risks, please read the Important Safety Information and the Medication Guide, and talk with your doctor.

The most common side effects of SIMPONI® include:

  • Upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis)
  • Reaction at the site of injection (redness, swelling, itching, pain, bruising, or tingling)
  • Viral infections such as flu and oral cold sores

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.

To learn more about these and other risks, please read the Important Safety Information for SIMPONI® and the Medication Guide, and talk with your doctor.

  • SIMPONI® is given as an injection under the skin (subcutaneous injection)
  • SIMPONI® comes in a prefilled syringe or SmartJect® autoinjector. Your doctor will prescribe the type that is best for you
  • If your doctor decides that you, your child, 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
    • Adults and children 12 years of age and older may self-inject with SIMPONI® prefilled syringe
    • Only adults may self-inject with SIMPONI® SmartJect® autoinjector
  • 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
  • See the detailed Instructions for Use that comes with your SIMPONI® for information about the right way to prepare and give your SIMPONI® injections at home

Please refer to the Medication Guide and Instructions for Use for more information on the right way to inject SIMPONI®.

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.

Use SIMPONI® exactly as prescribed by your doctor. Do not miss any doses of SIMPONI®. If you miss a dose of SIMPONI®, inject the missed dose as soon as possible. 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.

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. Be sure to let your doctor know about all the medicines you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements, before starting SIMPONI® or if you are scheduled for 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). People taking SIMPONI® can receive non-live vaccines.

Your doctor will forward your prescription to a specialty pharmacy based on your insurance coverage. The specialty pharmacy will call you about your insurance coverage and potential out-of-pocket costs, and to arrange delivery of your medicine. Your doctor may want your medicine shipped to the doctor's office for your first treatment. If authorized by your doctor, you may have your medicine shipped directly to your home or other location so you can self-inject. SIMPONI® is intended for use under the guidance and supervision of a doctor. Patients may self-inject SIMPONI® after doctor approval and proper training.

Biologic medicines such as SIMPONI® require special handling, and specialty pharmacies have experience in distributing these kinds of medicines. Specialty pharmacies offer you important benefits, including registered nurses and pharmacists who can answer questions about SIMPONI® and self-injection.

  • 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 that you remove SIMPONI® from the refrigerator on the carton
    • If SIMPONI® has reached room temperature, do not put 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 not freeze SIMPONI®
  • Keep SIMPONI® in the original carton to protect it from light when not being used
  • Do not shake 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.

After self-injecting with SIMPONI®, it's important to properly dispose of your used injection devices. People being treated with SIMPONI® can enroll in Safe Returns®, a unique service that allows you to properly and easily dispose of your used injection devices after each dose of SIMPONI®. Follow the instructions in the Safe Returns® pack. When your Safe Returns® mail-back box is received for disposal, a new pack will be sent to you in time for your next injection. To sign up for Safe Returns®, call 844-4withMe (844-494-8463).

You can also use a sharps container, a hard plastic container (such as a detergent bottle), or a metal container (such as an empty coffee can). Ask your doctor for the right way to dispose of the container. Also, it's important to note that used syringes cannot be recycled or placed in the household trash. Please refer to Instructions for Use for additional information on the proper disposal of your used syringes.

SIMPONI® is covered by many insurance plans, including:

  • Commercial or private insurance companies
  • Medicare
  • Medicaid

Different plans offer different coverage. If you have any questions about your coverage, first call your insurance provider. If you need more information or cost support for SIMPONI®, please visit JNJwithMe.com or call J&J withMe at 877-227-3728, Monday-Friday, 8:00 AM-8:00 PM ET.

The support and resources provided by J&J withMe are not intended to provide medical advice, replace a treatment plan you receive from your doctor or nurse, or serve as a reason for you to start or stay on treatment.

Once you and your doctor have decided that SIMPONI® is right for you:

J&J withMe can identify cost support options that may help with managing your out-of-pocket costs—whether you have commercial or private health insurance, government coverage such as Medicare or Medicaid, or have no insurance coverage.

Learn More

Eligible patients using commercial or private insurance can save on out-of-pocket medicine costs for SIMPONI®. Eligible patients pay $5 for each injection. Maximum program benefit per calendar year shall apply. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medicines. Terms expire at the end of each calendar year. Offer may change or end without notice. Restrictions, including monthly maximums, may apply. See program requirements.

The support and resources provided by J&J withMe are not intended to provide medical advice, replace a treatment plan you receive from your doctor or nurse, or serve as a reason for you to start or stay on treatment.

Please read the Important Safety Information about SIMPONI® below, and the Medication Guide, and talk with your doctor.