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Simponi Aria

Generic name: golimumab
Dosage form: intravenous (infusion) injection
Drug class: TNF alfa inhibitors

Medically reviewed by Nicole France, BPharm. Last updated on Jul 6, 2022.

What is Simponi Aria?

Simponi Aria (golimumab) is a type of biological drug called a monoclonal antibody that is used to treat a number of different types of arthritis.

Simponi Aria belongs to a group of medications called tumor necrosis factor (TNF) blockers. It works by preventing the pro-inflammatory cytokine TNF-alpha, which is made by your immune system, from interacting with its receptors.

TNF-alpha plays an important role in activating signaling pathways in the body, including those involved in inflammation, and fighting infection and cancer. However, excessive production of TNF-alpha can be harmful and contribute to the development of chronic inflammatory disease such as arthritis. Simponi Aria helps by blocking the damage caused by too much TNF-alpha.

Simponi Aria was approved by the US Food and Drug Administration (FDA) in 2013 and is given by intravenous (IV) infusion. Another formulation of golimumab that is administered by subcutaneous (under the skin) injection was approved in 2009 and is available under the brand name Simponi.

What is Simponi Aria used for?

Simponi Aria is a prescription medicine used to treat:

It is not known if this medication is safe and effective in children with psoriatic arthritis and polyarticular juvenile idiopathic arthritis under 2 years of age or in children with conditions other than these.

Important information

Infections

Simponi Aria is a medicine that affects your immune system. It can lower the ability of your immune system to fight infections. Some people have serious infections while receiving this medication, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that spread throughout their body. Some people have died from these serious infections.

  • Your doctor should test you for TB and hepatitis B before starting Simponi Aria.
  • Your doctor should monitor you closely for signs and symptoms of TB during treatment with Simponi Aria.

You should not start receiving this medication if you have any kind of infection unless your doctor tells you to.

Before receiving Simponi Aria, tell your doctor if you:

  • think you have an infection or have symptoms of an infection such as:
    • fever, sweat, or chills
    • muscle aches
    • cough
    • shortness of breath
    • blood in phlegm
    • weight loss
    • warm, red, or painful skin or sores on your body
    • diarrhea or stomach pain
    • burning when you urinate or urinate more often than normal
    • feel very tired
  • are being treated for an infection.
  • get a lot of infections or have infections that keep coming back.
  • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
  • have TB, or have been in close contact with someone with TB.
  • live, have lived, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys and the Southwest) where there is an increased chance for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use Simponi Aria. Ask your doctor if you do not know if you have lived in an area where these infections are common.
  • have or have had hepatitis B.
  • use the medicine Orencia (abatacept), Kineret (anakinra), Actemra (tocilizumab) or Rituxan (rituximab).

After receiving Simponi Aria, call your doctor right away if you have any symptoms of an infection. This medication can make you more likely to get infections or make worse any infection that you have.

Cancer

  • For children and adults receivingTNF-blocker medicines, including this medication, the chances of getting cancer may increase.
  • There have been cases of unusual cancers in children and teenage patients receiving TNF-blocking agents.
  • People with inflammatory diseases, including rheumatoid arthritis (RA), especially those with very active disease, may be more likely to get lymphoma.
  • Some people receiving TNF-blockers, like this medication, developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with a TNF blocker and another medicine called azathioprine or 6-mercaptopurine, (6-MP).
  • Some people treated with this medication developed skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with this medication, tell your doctor.
  • You should see your doctor periodically for skin examinations, especially if you have a history of skin cancer.

What should I tell my doctor before receiving Simponi Aria?

Before starting Simponi Aria, tell your doctor about all your medical conditions, including if you:

  • have an infection.
  • have or have had lymphoma or any other type of cancer.
  • have or have had heart failure.
  • have or have had a condition that affects your nervous system, such as multiple sclerosis or Guillain-Barré syndrome.
  • have a skin problem called psoriasis.
  • have recently received or are scheduled to receive a vaccine. People receiving this medication should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer). People receiving Simponi Aria can receive non-live vaccines.

How should I receive Simponi Aria?

  • Simponi Aria is prepared and given by a healthcare provider through a needle placed in your vein (infusion). The infusion is usually given in your arm and should take 30 minutes.
  • Your doctor will decide how much you will receive. Your usual schedule for receiving this medication after your first treatment should be:
    • 4 weeks after your first treatment
    • every 8 weeks after that

What happens if I miss a dose?

If you miss an appointment to receive Simponi Aria, make another appointment as soon as possible.

Dosing information

  • Adult patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis:
    • 2 mg/kg intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter
  • Pediatric patients with polyarticular juvenile idiopathic arthritis and psoriatic arthritis:
    • 80 mg/m2 intravenous infusion over 30 minutes at weeks 0 and 4, and every 8 weeks thereafter

See full prescribing information for further details about Simponi Aria dosing.

What are the side effects of Simponi Aria?

Serious side effects of Simponi Aria include:

  • See "Important information" above.
  • Serious Infections
    • Some patients have an increased chance of getting serious infections while receiving this medication. These serious infections include TB and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients die from these infections. If you get an infection while receiving treatment with this medication your doctor will treat your infection and may need to stop your treatment. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving this medication:
      • a fever
      • feel very tired
      • have a cough
      • have flu-like symptoms
      • warm, red, or painful skin
    • Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Simponi Aria and during treatment with it. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are receiving this medication. People who had a negative TB skin test before receiving this medication have developed active TB. Tell your doctor if you have any of the following symptoms while receiving or after receiving Simponi Aria:
      • cough that does not go away
      • low grade fever
      • weight loss
      • loss of body fat and muscle (wasting)
  • Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use this medication. Your doctor should do blood tests before you start treatment with and while you are receiving it.
    • Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:
      • feel very tired
      • dark urine
      • skin or eyes look yellow
      • little or no appetite
      • vomiting
      • muscle aches
      • clay-colored bowel movements
      • fevers
      • chills
      • stomach discomfort
      • skin rash
  • Heart failure, including new heart failure or worsening of heart failure that you already have can happen in people who use TNF-blocker medicines, including this medication. If you develop new or worsening heart failure with Simponi Aria, you may need to be treated in a hospital, and it may result in death.
    • If you have heart failure before starting this medication, your condition should be watched closely during treatment.
    • Call your doctor right away if you get new or worsening symptoms of heart failure during treatment with this medication (such as shortness of breath or swelling of your lower legs or feet, or sudden weight gain).
  • Nervous System Problems. Rarely, people receiving TNF-blocker medicines, including this one, have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you get any of these symptoms:
    • vision changes
    • weakness in your arms or legs
    • numbness or tingling in any part of your body
  • Immune System Problems. Rarely, people receiving TNF-blocker medicines have developed symptoms that are like the symptoms of lupus. Tell your doctor if you have any of these symptoms:
    • a rash on your cheeks or other parts of the body
    • sensitivity to the sun
    • new joint or muscle pains
    • becoming very tired
    • chest pain or shortness of breath
    • swelling of the feet, ankles, or legs
  • Liver Problems. Liver problems can happen in people who receive TNF-blocker medicines, including this medication. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
    • feel very tired
    • skin or eyes look yellow
    • poor appetite or vomiting
    • pain on the right side of your stomach (abdomen)
  • Blood Problems. Low blood counts have been seen with Simponi Aria. Your body may not make enough blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding easily, or looking pale. Your doctor will check your blood counts before and during treatment.
  • Allergic Reactions. Allergic reactions can happen in people who receive TNF-blocker medicines, including this medication. Some reactions may be serious and can be life-threatening. Some of these reactions can happen after receiving your first dose. Call your doctor right away if you have any of these symptoms of an allergic reaction:
    • hives
    • swollen face
    • breathing trouble
    • chest pain

The most common side effects of Simponi Aria include:

  • upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis)
  • abnormal liver tests
  • decreased blood cells that fight infection
  • viral infections, such as flu and cold sores in the mouth
  • bronchitis
  • high blood pressure
  • rash

These are not all of the possible side effects of.

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.

Interactions

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially, tell your doctor if you:

  • use Orencia (abatacept) or Kineret (anakinra). You should not receive Simponi Aria while you are also receiving these medicines.
  • use other TNF-blocker medicines, including Remicade (infliximab), Humira (adalimumab), Enbrel (etanercept), or Cimzia (certolizumab pegol).
  • receive Rituxan (rituximab) or Actemra (tocilizumab).

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Keep a list of all your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Simponi Aria will harm your unborn baby.

Tell your doctor if you have a baby and you were receiving Simponi Aria during your pregnancy. Tell your baby's doctor before your baby receives any vaccine. Your baby may have an increased chance of getting an infection for up to 6 months after birth.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Simponi Aria passes into your breast milk. You and your doctor should decide if you will receive this medication or breastfeed.

Storage

  • Refrigerate Simponi Aria at 36ºF to 46ºF (2ºC to 8ºC) and protect from light.
  • Keep the product in the original carton to protect from light until the time of use.
  • Do not freeze.
  • Do not shake.
  • If needed this medication may be stored at room temperature up to 77ºF (25ºC) for a maximum single period of 30 days in the original carton to protect from light. Once it has been stored at room temperature, do not return the product to the refrigerator. If not used within 30 days at room temperature, discard this medication.

What are the ingredients in Simponi Aria?

Active ingredient: golimumab.

Inactive ingredients: L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sorbitol, and water for injection. Simponi Aria is preservative-free and is not made with natural rubber latex.

Simponi Aria is manufactured by Janssen Biotech, Inc. Horsham, PA 19044.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.