Other Important Considerations

If you are currently taking a DMARD(s) and your treatment is not relieving the pain, stiffness, and swelling of your moderate to severe rheumatoid arthritis (RA), your doctor may suggest starting you on a biologic medication, such as SIMPONI®. It’s only natural to have questions and concerns about starting on a biologic medication.

Here are some important things you should know about treatment with SIMPONI®:

Is SIMPONI® right for me?

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.

What should I know about serious side effects?

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, 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.

What are the common side effects?

The common side effects of treatment with SIMPONI® include:

  • upper respiratory tract infection
  • reaction at the site of injection
  • viral infections such as flu and oral cold sores

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

How do I take SIMPONI®?

SIMPONI® is given as an injection under the skin. After you are trained by your healthcare provider, you can take SIMPONI® by giving yourself an injection with the SmartJect® autoinjector or a prefilled syringe. Both injection devices provide a low volume of medicine (0.5 mL) with each dose. Please refer to the Medication Guide, and Instructions for Use, for more information on the right way to self-inject SIMPONI®.

How often do I take SIMPONI®?

SIMPONI® is taken as a single injection just once a month. It is the first and only self-injectable biologic treatment for adults with moderate to severe rheumatoid arthritis (RA) that requires just one injection each month. SIMPONI® is taken with the medicine methotrexate, as directed.

Are SIMPONI® injections painful?

For most people with moderate to severe RA, active psoriatic arthritis or active ankylosing spondylitis who participated in clinical trials, SIMPONI® injections were pain-free. Less than 1% of people treated with SIMPONI® reported experiencing any injection site pain, and only 6% experienced injection site reactions, such as redness, swelling, itching, pain, bruising, or tingling. To learn more about these and other risks, please read the Important Safety Information about SIMPONI® below, and the
Medication Guide, and talk with your doctor.

What if I miss a dose of SIMPONI®?

Use SIMPONI® exactly as prescribed by your doctor. 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 regularly scheduled time. In case you’re not sure when to inject SIMPONI®, call your doctor or pharmacist.

How should I store SIMPONI®?

When you receive your monthly dose of SIMPONI®, immediately place it in a refrigerator at 36°F to 46°F (2°C to 8°C) until you’re ready to use it. Do not freeze or shake SIMPONI®. Keep it in the carton when not being used to protect it from light. When you are ready to inject, allow your SIMPONI® to sit at room temperature, outside the carton for 30 minutes.

Can I take SIMPONI® if I’m taking other medications?

While taking SIMPONI® you may continue to use other medications that help treat your condition, 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 medications you are taking before starting SIMPONI®, 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). 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.

Next: Important Safety Information