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Simponi® (golimumab)and Simponi Aria® (golimumab)

Simponi and Simponi Aria are biologic therapies approved to treat three inflammatory arthritis conditions: ankylosing spondylitis (AS), rheumatoid arthritis, and psoriatic arthritis. In AS, biologics like Simponi and Simponi Aria may be used in people who have not been adequately managed with NSAIDs (non-steroidal anti-inflammatory drugs). Simponi is given as an injection, while Simponi Aria is administered as an intravenous (IV) infusion.1,2

What is the ingredient in Simponi and Simponi Aria?

The active ingredient in both Simponi and Simponi Aria is golimumab, a monoclonal antibody that blocks tumor necrosis factor-alpha (TNF-alpha).1,2

How do Simponi and Simponi Aria work?

Simponi and Simponi Aria are monoclonal antibodies that are TNF-alpha inhibitors. TNF is a protein, called a cytokine, that is naturally produced by the body’s immune system. In people with certain inflammatory conditions, like AS, there is an excess of TNF-alpha, which leads to joint pain and stiffness. By blocking TNF, Simponi and Simponi Aria can reduce the inflammation and relieve the symptoms of AS.1,2

What are the possible side effects of Simponi and Simponi Aria?

Because Simponi and Simponi Aria interfere with one of the proteins involved in the immune system function (TNF-alpha), they may impair your body’s ability to fight infections. Some people have experienced serious infections with TNF inhibitors like Simponi and Simponi Aria, including tuberculosis (TB), bacterial sepsis, invasive fungal infections, and opportunistic infections. Some of these serious infections may lead to hospitalizations or death.1,2

Simponi and Simponi Aria may increase the risk of developing lymphoma or other types of cancer. This risk may be increased in children and young adults.1,2

Simponi or Simponi Aria may cause a serious allergic reaction. Patients who experience hives, trouble breathing, or swelling of the face, lips, or mouth should seek immediate medical attention.1,2

The most common side effects experienced by patients taking Simponi include infections (such as upper respiratory infections and the common cold) and injection site reactions (such as pain, redness, or swelling).1 The most common side effects experienced by patients taking Simponi Aria include upper respiratory infection, abnormal liver tests, decreased blood cells that fight infection, viral infections, bronchitis, high blood pressure, and rash.2

This is not an exhaustive list of all potential side effects of Simponi and Simponi Aria. For more information, patients should talk to their doctor about what to expect. Any new or worsening side effects should be reported to a doctor or healthcare professional.

Things to know about Simponi and Simponi Aria

Before starting treatment with Simponi or Simponi Aria, patients should talk to their doctors about all their medical conditions, especially if they:1,2

  • Have any signs of infection (fever, chills, cough, muscle aches, shortness of breath, sores, diarrhea, burning during urination) or are prone to frequent infections
  • Have any open cuts or sores
  • Have diabetes
  • Have psoriasis
  • Tested positive for TB or have been in close contact with someone who has TB
  • Were born in, lived in, or traveled to countries where there is an increased risk of TB (ask your doctor if you aren’t sure)
  • Live in areas of the US (like the Ohio and Mississippi River valleys) where known for fungal infections
  • Have or have had hepatitis B
  • Have any nervous system problems like multiple sclerosis or Guillain-Barré syndrome
  • Have or have had cancer
  • Have or have had heart failure
  • Are scheduled to receive a vaccine
  • Are allergic to rubber or latex
  • Are pregnant or plan to become pregnant or are breastfeeding

Before beginning treatment with Simponi or Simponi Aria, patients should talk to their doctors about all medications (over-the-counter and prescription), vitamins, and supplements they are taking, especially any other biologics. Some medications or supplements may increase the risk of side effects if taken in combination with Simponi or Simponi Aria.1,2

Patients should be tested for TB before beginning treatment with Simponi or Simponi Aria.1,2</sup<

If an infection occurs while taking Simponi or Simponi Aria, patients should contact their doctor. If the infection becomes serious, treatment with Simponi or Simponi Aria may be stopped.1,2

Patients taking Simponi or Simponi Aria should not receive live vaccines.1,2

During treatment with Simponi or Simponi Aria, patients should be monitored for any possible heart problems, anemia, infection, cancers, and nerve damage.1

Dosing information
Simponi is a once-monthly injection that is given under the skin (subcutaneously) to treat the symptoms of AS.1

Simponi Aria is an IV infusion that is given at weeks 0 and week 4 of treatment, and then every 8 weeks.2

Patients should talk to their doctor about any questions on their dosing regimen.

Written by: Emily Downward | Last reviewed: February 2019
  1. Simponi prescribing information. Available at http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI-pi.pdf. Accessed 1/17/19.
  2. Simponi Aria prescribing information. Available at http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/SIMPONI+ARIA-pi.pdf. Accessed 1/17/19.