Frequently Asked Questions About SIMPONI®

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

  • Moderate to severe rheumatoid arthritis (RA), taken with the medicine methotrexate
  • Active psoriatic arthritis (PsA), taken alone or with the medicine methotrexate
  • Active ankylosing spondylitis (AS)
  • To learn more about SIMPONI® for the treatment of moderately to severely active ulcerative colitis (UC), click here

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 talk with your doctor about any symptoms or questions.

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, lupus-like syndrome, 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 common side effects of treatment with SIMPONI® include:

  • Upper respiratory tract infection
  • Reaction at the site of injection
  • Viral infections like the flu, or oral cold sores

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

SIMPONI® is given as an injection under the skin. Your healthcare provider will teach you how to give yourself the injection.

Please refer to the Medication Guide and Instructions for Use for more information on the right way to inject SIMPONI®. Click here for our injection demonstration videos.

Once you and your doctor are comfortable with the self-injection process, SIMPONI® is a medicine you inject under the skin—only one injection each month. See how the SIMPONI® dosing schedule compares with other products.

Use SIMPONI® exactly as prescribed by your doctor.

It’s important not to miss any doses of SIMPONI®. If you do forget to take a dose:

  • Inject SIMPONI® as soon as you remember
  • Take your next dose at your regularly scheduled time

If you're not sure when to inject SIMPONI®, call your doctor or pharmacist.

It’s up to your doctor. Your doctor may want you to keep taking other medicines that help your condition, such as:

  • Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Prescription steroids

Be sure to let your doctor know about all the medications you are taking before starting SIMPONI®, or if you 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). Use of SIMPONI® with Orencia®* (abatacept), Actemra®* (tocilizumab), or Kineret®* (anakinra) is not recommended, due to an increased risk of serious infections. A higher rate of serious infections has also been observed in RA patients treated with Rituxan®* (rituximab) and Actemra®* (tocilizumab) who received subsequent treatment with a TNF-blocker. SIMPONI® should not be used along with another TNF-blocker medicine.

*Indicated trademarks are the registered trademarks of their respective owners.

  • The doctor will send your prescription to a special pharmacy
  • The pharmacy will call you to arrange delivery of your medicine
  • Your doctor may want to have your first month’s medication shipped to his or her office
  • After that, with your doctor’s permission, you may have your medication shipped right to your home

Biologic medications like SIMPONI® need special handling. Specialty pharmacies have experience handling biologics. They also have nurses and pharmacists who can answer your questions about SIMPONI® and self-injection.

  • As soon as you receive your monthly dose of SIMPONI®, put it in a refrigerator at 36°F to 46°F (2°C-8°C)
  • Keep it in the refrigerator until you’re ready to use it
  • Do not freeze or shake SIMPONI®
  • Store SIMPONI® in its carton to protect it from light
  • When you are ready to inject, let it sit at room temperature, outside the carton, for 30 minutes

It's important to discard your used injection devices and sharps (needles and syringes) safely. Janssen CarePath offers Safe Returns® service—a free, convenient way to get rid of used devices, and get new disposal containers by mail.

Follow the instructions in the Safe Returns® pack. To sign up for Safe Returns®, call 877-CarePath (877-227-3728) Monday – Friday, 8:00 am – 8:00 pm ET.

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

  • Made of a heavy-duty plastic
  • Can be closed with a tight-fitting, puncture-resistant lid that doesn't allow sharps to come through
  • Upright and stable during use
  • Leak-resistant
  • Properly labeled to warn of hazardous waste inside the container

When your sharps disposal container is almost full, follow your community guidelines for the right way to dispose of the container. There may be state or local laws about how you should throw away used sharps.

For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, visit www.fda.gov/safesharpsdisposal.

Remember, you can’t recycle used syringes or put them in the trash. Please refer to Instructions For Use for more information on how to discard 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 financial assistance for SIMPONI®, please call Janssen CarePath at 877-CarePath (877-227-3728), Monday–Friday, 8:00 am–8:00 pm ET.

Your Janssen CarePath Care Coordinator can:

  • Review your health plan benefits to help answer questions you may have about insurance coverage for SIMPONI®
  • Identify options that may help make SIMPONI® more affordable, if needed
  • Review available services and help you choose the services that may best meet your needs
  • Work with your specialty pharmacy to process and deliver your SIMPONI® medication to your home or your doctor’s office
  • Provide treatment education support

If you have any questions, please call Janssen CarePath at 877-CarePath (877-227-3728), Monday through Friday, between 8 am and 8 pm ET.

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