summary

Here is a passage from the SIMPONI ARIA MEDICATION GUIDE, which may be helpful to address your question:

What is the most important information I should know about SIMPONI ARIA?

• SIMPONI ARIA is a medicine that affects your immune system. SIMPONI ARIA can lower the ability of your immune system to fight infections.¹

Serious infections

• Some patients have an increased chance of getting serious infections while receiving SIMPONI ARIA. These serious infections include tuberculosis (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 SIMPONI ARIA, your doctor will treat your infection and may need to stop your SIMPONI ARIA treatment. Tell your doctor right away if you have any of the following signs of an infection while receiving or after receiving SIMPONI ARIA¹:
  • 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 SIMPONI ARIA. Even if your TB test is negative, your doctor should carefully monitor you for TB infections while you are receiving SIMPONI ARIA. People who had a negative TB skin test before receiving SIMPONI ARIA have developed active TB. Tell your doctor if you have any of the following symptoms while receiving or after receiving SIMPONI ARIA¹:
  • Cough that does not go away
  • Low grade fever
  • Weight loss
  • Loss of body fat and muscle (wasting)
• You should not start receiving SIMPONI ARIA if you have any kind of infection unless your doctor tells you to.¹

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 SIMPONI ARIA. Your doctor should do blood tests before you start treatment with SIMPONI ARIA and while you are receiving SIMPONI ARIA.¹
  • 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

The most common side effects of SIMPONI ARIA include:

• Upper respiratory infection (runny nose, sore throat, and hoarseness or laryngitis)¹
• Abnormal liver tests¹
• Decreased blood cells that fight infection¹
• Viral infections, such as flu and cold sores in the mouth¹
• Bronchitis¹
• High blood pressure¹
• Rash¹

These are not all of the possible side effects of SIMPONI ARIA.¹

Before receiving SIMPONI ARIA, tell your doctor if you:

• Think you have an infection or have symptoms of an infection such as¹:
  • 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.¹
• Get a lot of infections or have infections that keep coming back.¹
• Have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.¹
• Have TB, or have been in close contact with someone with TB.¹
• 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.¹
• Have or have had hepatitis B.¹
• Use the medicine ORENCIA^® (abatacept), KINERET^® (anakinra), ACTEMRA^® (tocilizumab) or RITUXAN^® (rituximab).¹

After receiving SIMPONI ARIA, call your doctor right away if you have any symptoms of an infection. SIMPONI ARIA can make you more likely to get infections or make worse any infection that you have.¹

additional information

This information is provided ONLY in response to your request and is not intended as medical advice, to promote the use of our product, or suggest using it in any manner other than as described in the PRESCRIBING INFORMATION. All decisions regarding your medical treatment should be made with your healthcare professional(s). Please contact your healthcare professional(s) to discuss the information in this response.

Please refer to the attached full PRESCRIBING INFORMATION and the MEDICATION GUIDE for SIMPONI ARIA.¹