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Proven in the treatment of adults with moderate to severe rheumatoid arthritis (RA), taken with methotrexate. SIMPONI® ARIA™ helps relieve pain, stiffness, and swelling, helps stop further joint damage, and improves your ability to do things you need to do with less difficulty when taken with methotrexate. Individual results may vary.
SIMPONI® ARIA™ is given:
as a short 30-minute infusion by a healthcare professional
once every 8 weeks, after 2 starter doses given 4 weeks apart
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.
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.
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
shortness of breath
blood in phlegm
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.
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
skin or eyes look yellow
little or no appetite
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-Barrè 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.