Simponi/Simponi Aria (golimumab)

Simponi is used to treat moderately to severely active rheumatoid arthritis (RA) in adults, in combination with methotrexate. Simponi is available as a once-monthly injection; an intravenous form, Simponi Aria, is also available. Simponi is a human immunoglobulin G1 (IgG1) monoclonal antibody manufactured by Janssen Biotech, Inc. It is classified as a biologic disease modifying anti-rheumatic drug (DMARD).

Simponi is also used to treat three other autoimmune diseases, ankylosing spondylitis, ulcerative colitis and psoriatic arthritis.¹

What are the ingredients in Simponi?

The active ingredient in Simponi is golimumab.

How does Simponi work?

Simponi is a tumor necrosis factor (TNF) inhibitor. TNF-alpha is a protein produced by the body’s immune system. In people with certain autoimmune diseases, like RA, there is an excess of TNF-alpha, which leads to joint pain, stiffness, and swelling. Simponi targets and binds to the excess TNF-alpha, which reduces the joint symptoms of RA and prevents further damage to the joints.^1,2

What are the possible side effects of Simponi?

The most common side effects experienced by people taking Simponi in clinical trials were upper respiratory tract infections, colds (nasopharyngitis), and injection site reactions, such as redness or pain. Other side effects that may occur with Simponi use include:

• Activation of hepatitis B in people who carry the virus, and some of these cases have led to death.
• Heart failure can occur or worsen in people who use TNF blockers like Simponi, and your doctor will closely monitor you if you have heart failure. Signs of heart failure include shortness of breath, swelling of your legs or feet, or sudden weight gain.
• Nervous system problems, such as multiple sclerosis (MS) or Guillain-Barré syndrome.
• Immune system problems or lupus-like symptoms, which may appear as a rash on the cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, feeling very tired, chest pain, shortness of breath, or swelling of the feet, ankles and/or legs.
• Serious liver problems, which may appear as feeling very tired, a yellowish tint to the skin or eyes, poor appetite, vomiting, or pain on the right side of the stomach.
• Changes to the blood cells, such as low blood counts. A reduction in platelets can cause difficulty with clotting and lead to bleeding episodes. A reduction in white blood cells can impact the body’s ability to fight infections, and a reduction in red blood cells can lead to anemia, making you feel tired or weak.
• Allergic reaction, or a hypersensitivity reaction, which may appear as hives, swollen face, difficulty breathing, or chest pain.^1,2

Because Simponi interferes with one of the chemicals involved in the immune system function (TNF-alpha), it may impair your body’s ability to fight infections. Simponi has a black box warning, the strictest warning from the U.S. Food and Drug Administration (FDA) because of its potential to cause serious side effects, namely:

• Serious infections that can lead to hospitalizations or death, such as tuberculosis (TB), bacterial sepsis, invasive fungal, viral, and other opportunistic infections
• Lymphoma and other cancers, including skin cancers; some cancers have lead to death¹

Things to know about Simponi

There is an increased risk for serious infections with Simponi. This is because Simponi can decrease the ability of the immune system to fight infections. If you have an active infection, you should not take Simponi. If you develop a serious infection while taking Simponi, contact your doctor immediately. You may need to interrupt or discontinue treatment with Simponi. Common signs of infection include:

• Fever, sweat, or chills
• Achy muscles
• Cough
• Shortness of breath
• Blood in phlegm
• Weight loss
• Sores on the body that are warm, red, or painful
• Diarrhea or stomach pain
• Burning during urination or more frequent urination
• Feeling very tired^1,2

Before taking Simponi, you should talk to your doctor about all your medical conditions, including:

• Any infections or symptoms of an infection
• Frequent infections or infections that keep returning
• Diabetes
• HIV or a weak immune system
• Tuberculosis (TB) or having had close contact with someone who has TB (monitor for TB prior to and during treatment)
• Having or have had hepatitis B
• Cancer
• Heart failure
• Demyelinating disorders
• Recent vaccinations
• Pregnancy or planning to become pregnant
• Breastfeeding or planning to breastfeed
• Known allergic (hypersensitivity) reaction to Simponi or any of the ingredients in Simponi¹

People taking Simponi should not receive live vaccines but can receive non-live vaccines. Talk to your doctor before receiving any vaccines if you are unsure about what kind of vaccine you are getting.^1,2

Talk to your doctor or pharmacist about all prescription and over-the-counter medications you are taking, as well as any vitamins, nutritional supplements, and herbal products you take, as some of these may interact with Simponi. In particular, you should talk to your doctor about all medications you take to treat RA, including Orencia ® (abatacept), Kineret® (anakinra), Actemra® (tocilizumab), Rituxan® (rituximab), or another TNF blocker. People taking Simponi should not receive treatment with a weakened bacteria, such as BCG for bladder cancer.^1,2