Simponi Aria

Simponi Aria is a prescription medication used, along with another medication called methotrexate, to treat moderate to severe rheumatoid arthritis in adults. Simponi Aria is also used to treat adults with active psoriatic arthritis and active ankylosing spondylitis.

Simponi Aria belongs to class of medications called tumor necrosis factor (TNF) inhibitors. These work by blocking the action of TNF, a substance in the body that promote inflammation.

This medication is available in an injectable form to be given directly into a vein by a healthcare professional, typically every 8 weeks. 

Common side effects of Simponi Aria include upper respiratory tract infections, viral infections, and skin rashes.

Simponi Aria can also cause dizziness. Do not drive or operate heavy machinery until you know how Simponi Aria affects you.

Simponi Aria is a prescription medication used, along with another medication called methotrexate, to treat moderately to severely active rheumatoid arthritis in adults. Simponi Aria is also used to treat adults with active psoriatic arthritis and active ankylosing spondylitis.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Biotech, Inc.

Serious side effects have been reported with Simponi Aria. See the “Simponi Aria Precautions” section.

Common side effects of Symponi Aria include:

• upper respiratory infections such as runny nose, sore throat, and hoarseness or laryngitis
• redness and/or pain at the injection site
• skin rashes
• bronchitis
• high blood pressure
• viral infections such as flu and/or cold sores in the mouth

This is not a complete list of Symponi Aria side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other biologic medications such as abatacept (Orencia) or anakinra (Kineret)
• live vaccines such vaccines for MMR, rotavirus, typhoid, smallpox, and for influenza (nasal spray form)
• medications that use the enzyme CYP450 such as cyclosporine (Neoral, Gengraf, Sandimmune), warfarin (Coumadin, Jantoven), and theophylline

This is not a complete list of Simponi Aria drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Simponi Aria including:

• Reduced immune system function. Some people have developed serious infections while taking Simponi Aria, 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 and closely monitor you for signs and symptoms of TB during treatment. You should not start taking Simponi Aria if you have any kind of infection unless your doctor says it is okay. After starting Simponi Aria, call your doctor right away if you have any symptoms of an infection.
• Cancer. For children and adults taking Simponi Aria, the risk of developing cancer may increase. People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to develop lymphoma. Some people treated with Simponi Aria have developed certain kinds of skin cancer. If any changes in the appearance of your skin or growths on your skin occur during or after your treatment with Simponi Aria, tell your doctor immediately.
• Hepatitis B infection reactivation. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Simponi Aria. Your doctor should do blood tests before you start treatment with Simponi Aria and while you are using Simponi Aria. 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
• Congestive heart failure (CHF). Simponi Aria may worsen current CHF or may cause CHF. Simponi Aria should be used with caution in patients with CHF and those with CHF and also taking Simponi Aria should be closely monitored during therapy. Simponi Aria should be discontinued if new or worsening symptoms of CHF appear. Symptoms of CHF include shortness of breath, swelling in arms or legs, and general weakness and fatigue.
• Nervous system diseases. Be sure to inform your physician before beginning treatment with Simponi Aria if you have or have ever had any nervous system diseases.
• Liver Problems. Liver problems can occur in people who use Simponi Aria. These problems can lead to liver failure and possibly death. Call your doctor right away if you have any of these symptoms:
  • feel very tired
  • skin or eyes look yellow
  • poor appetite
  • vomiting
  • pain on the right side of your stomach (abdomen)
• Blood Problems. Low blood counts have been seen with Simponi Aria use. Your body may not make enough blood cells to help fight infections or help stop bleeding. Symptoms of low blood counts include fever, bruising or bleeding easily, or looking pale. Your doctor will check your blood counts before and during treatment with Simponi Aria.                         
• Psoriasis. Some people using Simponi Aria have developed new-onset psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly skin patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Simponi Aria.
• Allergic Reactions. Severe allergic reactions can occur in people who use Simponi Aria. Some reactions may be serious and can even be life-threatening. Some of these reactions can occur after receiving your first dose of Simponi Aria. Call your doctor right away if you have any of these symptoms of a severe allergic reaction:
  • hives
  • swollen face, tongue, and/or lips
  • difficulty breathing
• New onset or worsening of demyelinating disorders (disorder of the nervous system), including multiple sclerosis or Guillain-Barré syndrome.
  • Rare cases of this complication have been reported in patients treated with Simponi Aria.
  • Discontinuation of Simponi Aria should be considered if this condition occurs.  

Do not take Simponi Aria if you are allergic to Simponi Aria or to any of its ingredients. 

Simponi Aria may also cause dizziness. Do not drive or operate heavy machinery until you know how golimumab affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Simponi Aria, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Simponi Aria, tell your doctor about all of your medical conditions. Especially 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 urinating more often than normal
  • feel very tired
• are being treated for an infection
• frequently have infections or have infections that keep coming back
• have a history of any type of cancer
• have a history of heart failure
• have or have had hepatitis B
• have diabetes, HIV, or a weak immune system
• have TB, or have been in close contact with someone with TB
• have or have had a condition that affects your nervous system (e.g., multiple sclerosis or Guillain-Barré syndrome)
• have a skin problem called psoriasis
• have recently received or are planning to receive a vaccine
• are allergic to rubber or latex, as the needle cover on the syringe and autoinjector are made with dry natural rubber
• are pregnant, planning to become pregnant, or are breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Simponi Aria falls into category B. There are no well-controlled studies of Simponi Aria in pregnant women, and so it is unknown whether Simponi Aria can cause fetal harm when administered to a pregnant woman. Simponi Aria should be used during pregnancy only if clearly needed.

Infants born to women treated with Simponi Aria during pregnancy may be at increased risk of infection for up to 6 months. Administration of live vaccines to infants are not recommended for 6 months following last Simponi Aria infusion during pregnancy. Tell your baby's doctor know before your baby is given any vaccine. 

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Simponi Aria crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Simponi Aria.

Receive Simponi Aria exactly as prescribed.

Simponi Aria is available in an injectable form to be given directly into a vein by a healthcare professional.  

After the first dose, it will typically be given 4 weeks after, then every 8 weeks thereafter. 

For treatment of rheumatoid arthritis, Simponi Aria is given with another medication called methotrexate. The infusion is usually given into your arm and should take about 30 minutes.

If you miss a dose, make a follow up appointment immediately.

Receive this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your age

The recommended dose of Simponi Aria for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis in adults is 2 mg per kilogram of body weight injected into a vein (intravenously) over 30 minutes at weeks 0 and 4, then every 8 weeks thereafter.

Since Simponi Aria is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Serious infections

Patients treated with Simponi Aria are at an increased risk for developing serious infections that may lead to hospitalization and/or death. Most patients who developed these infections were also taking immunosuppressant medications such as methotrexate or corticosteroids.

Reported infections include:

• Active tuberculosis, including reactivation of latent tuberculosis

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis

• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria

Consider the risks and benefits of treatment with Simponi Aria prior to starting therapy. Your physician will closely monitor you for the development of signs and symptoms of infection during and after treatment with Simponi Aria, including the possible development of tuberculosis.

Malignancy

Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with Simponi Aria.