I am able to take the next step with my doctor in treating my RA.

For adults with moderate to severe rheumatoid arthritis (RA), SIMPONI® ARIA, taken with the medicine methotrexate has been proven to help:
  • relieve the pain, stiffness, and swelling of RA
  • stop further joint damage
  • improve your ability to perform every day activities with less difficulty

Results may not be the same for everyone.

SIMPONI® ARIA is given:
  • as a short 30-minute infusion prepared and given by a healthcare professional through a needle placed in your vein, usually in your arm
  • once every 8 weeks, after 2 starter doses, 4 weeks apart
Selected Important Safety Information

SIMPONI® ARIA (golimumab) can lower your ability to fight infections. Serious and sometimes fatal events may occur. There have been reports of serious infections including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that have spread throughout the body. Other possible serious side effects may include lymphoma, skin cancer, other cancers, hepatitis B, heart failure, nervous system problems, or allergic reactions. To learn more about these and other risks, please read the Important Safety Information, and the Medication Guide, and talk with your doctor.

IMPORTANT SAFETY INFORMATION Expand

SIMPONI® ARIA (golimumab) is a prescription medicine. SIMPONI® ARIA can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® ARIA and will closely monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not receive SIMPONI® ARIA if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs 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 than normal
  • feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI® ARIA, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI® ARIA developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI® ARIA. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI® ARIA should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI® ARIA. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI® ARIA. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

  • feel very tired
  • clay-colored bowel movements
  • dark urine
  • fevers
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • chills
  • stomach discomfort
  • skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI® ARIA. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.

Rarely, people using TNF blockers, including SIMPONI® ARIA, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

Serious liver problems can happen in people using TNF blockers, including SIMPONI® ARIA. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including SIMPONI® ARIA. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Tell your doctor if you have any symptoms of an allergic reaction while receiving SIMPONI® ARIA such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles or legs.

Tell your doctor if you have psoriasis.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and received SIMPONI® ARIA during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

The most common side effects of SIMPONI® ARIA include: upper respiratory infection, viral infections, bronchitis, high blood pressure, and rash.

Please read the full Prescribing Information and Medication Guide for SIMPONI® ARIA and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

SIMPONI® ARIA is a biologic treatment for adults with moderate to severe rheumatoid arthritis (RA), used with the medicine methotrexate. SIMPONI® ARIA is prepared and given by your healthcare provider as a 30-minute infusion every 8 weeks after 2 starter infusions, given 4 weeks apart. The infusion is given through a needle placed in your vein, usually in your arm. Methotrexate is taken as directed.

IMPORTANT SAFETY INFORMATION Expand

SIMPONI® ARIA (golimumab) is a prescription medicine. SIMPONI® ARIA can lower your ability to fight infections. There are reports of serious infections caused by bacteria, fungi, or viruses that have spread throughout the body, including tuberculosis (TB) and histoplasmosis. Some of these infections have been fatal. Your doctor will test you for TB before starting SIMPONI® ARIA and will closely monitor you for signs of TB during treatment. Tell your doctor if you have been in close contact with people with TB. Tell your doctor if you have been in a region (such as the Ohio and Mississippi River Valleys and the Southwest) where certain fungal infections like histoplasmosis or coccidioidomycosis are common.

You should not receive SIMPONI® ARIA if you have any kind of infection. Tell your doctor if you are prone to or have a history of infections or have diabetes, HIV or a weak immune system. You should also tell your doctor if you are currently being treated for an infection or if you have or develop any signs 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 than normal
  • feel very tired

Unusual cancers have been reported in children and teenage patients taking TNF-blocker medicines. For children and adults receiving TNF blockers, including SIMPONI® ARIA, the chances for getting lymphoma or other cancers may increase. You should tell your doctor if you have had or develop lymphoma or other cancers.

Some people treated with SIMPONI® ARIA developed skin cancer. Tell your doctor if any changes in the appearance of your skin or growths on your skin occur during or after your treatment with SIMPONI® ARIA. Your doctor should periodically examine your skin, especially if you have a history of skin cancer.

Tell your doctor about all the medications you take including ORENCIA (abatacept), KINERET (anakinra), ACTEMRA (tocilizumab), RITUXAN (rituximab), or another TNF blocker, or if you are scheduled to or recently received a vaccine. People receiving SIMPONI® ARIA should not receive live vaccines or treatment with a weakened bacteria (such as BCG for bladder cancer).

Reactivation of hepatitis B virus has been reported in patients who are carriers of this virus and are receiving TNF-blocker medicines, such as SIMPONI® ARIA. Some of these cases have been fatal. Your doctor should do blood tests before and after you start treatment with SIMPONI® ARIA. Tell your doctor if you know or think you may be a carrier of hepatitis B virus or if you experience signs of hepatitis B infection, such as:

  • feel very tired
  • clay-colored bowel movements
  • dark urine
  • fevers
  • skin or eyes look yellow
  • little or no appetite
  • vomiting
  • muscle aches
  • chills
  • stomach discomfort
  • skin rash

Heart failure can occur or get worse in people who use TNF blockers, including SIMPONI® ARIA. Your doctor will closely monitor you if you have heart failure. Tell your doctor right away if you get new or worsening symptoms of heart failure like shortness of breath, swelling of your lower legs or feet, or sudden weight gain.

Rarely, people using TNF blockers, including SIMPONI® ARIA, can have nervous system problems such as multiple sclerosis or Guillain-Barré syndrome. Tell your doctor right away if you have symptoms like vision changes, weakness in your arms or legs, or numbness or tingling in any part of your body.

Serious liver problems can happen in people using TNF blockers, including SIMPONI® ARIA. Contact your doctor immediately if you develop symptoms such as feeling very tired, skin or eyes look yellow, poor appetite or vomiting, or pain on the right side of your stomach.

Low blood counts have been seen with people using TNF blockers, including SIMPONI® ARIA. If this occurs, your body may not make enough blood cells to help fight infections or help stop bleeding. Your doctor will check your blood counts before and during treatment. Tell your doctor if you have signs such as fever, bruising, bleeding easily, or paleness.

Tell your doctor if you have any symptoms of an allergic reaction while receiving SIMPONI® ARIA such as hives, swollen face, breathing trouble, or chest pain. Some reactions can be serious and life-threatening.

Rarely, people using TNF blockers have developed lupus-like symptoms. Tell your doctor if you have any symptoms such as a rash on your cheeks or other parts of the body, sensitivity to the sun, new joint or muscle pain, becoming very tired, chest pain or shortness of breath, swelling of the feet, ankles or legs.

Tell your doctor if you have psoriasis.

Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding or have a baby and received SIMPONI® ARIA during pregnancy. Tell your baby’s doctor before your baby receives any vaccine because of an increased risk of infection for up to 6 months after birth.

The most common side effects of SIMPONI® ARIA include: upper respiratory infection, viral infections, bronchitis, high blood pressure, and rash.

Please read the full Prescribing Information and Medication Guide for SIMPONI® ARIA and discuss any questions you have with your doctor.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

SIMPONI® ARIA is a biologic treatment for adults with moderate to severe rheumatoid arthritis (RA), used with the medicine methotrexate. SIMPONI® ARIA is prepared and given by your healthcare provider as a 30-minute infusion every 8 weeks after 2 starter infusions, given 4 weeks apart. The infusion is given through a needle placed in your vein, usually in your arm. Methotrexate is taken as directed.

© Janssen Biotech, Inc. 2014

This site is published by Janssen Biotech, Inc., which is solely responsible for its contents. The material on this site is intended only as informational or as an educational aid and is not intended to be taken as medical advice. The ultimate responsibility for patient care resides with a healthcare professional.

The information on this site is intended for the use of patients and caregivers in the United States and Puerto Rico only. Laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The Prescribing Information included here may not be appropriate for use outside the United States and Puerto Rico.

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Last Updated March 1, 2014