Golimumab

What it is used for

SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate Active Psoriatic Arthritis (PsA) in patients 2 years of age and older Adult patients with active Ankylosing Spondylitis (AS) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

1.2 Psoriatic Arthritis (PsA) SIMPONI ARIA is indicated for the treatment of active psoriatic arthritis in patients 2 years of age and older. 1.3 Ankylosing Spondylitis (AS) SIMPONI ARIA is indicated for the treatment of adult patients with active ankylosing spondylitis. 1.4 Polyarticular Juvenile Idiopathic Arthritis (pJIA) SIMPONI ARIA is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) in patients 2 years of age and older.

The most important thing to know

SIMPONI ARIA is a medicine that affects your immune system. SIMPONI ARIA can lower the ability of your immune system to fight infections. Some people have serious infections while receiving 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. Your doctor should monitor you closely for signs and symptoms of TB during treatment with SIMPONI ARIA. You should not start receiving SIMPONI ARIA 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.

SIMPONI ARIA can make you more likely to get infections or make worse any infection that you have. Cancer For children and adults receiving Tumor Necrosis Factor (TNF)-blocker medicines, including SIMPONI ARIA, 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 SIMPONI ARIA, 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 SIMPONI ARIA developed 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.

You should see your doctor periodically for skin examinations, especially if you have a history of skin cancer. What is SIMPONI ARIA? SIMPONI ARIA is a prescription medicine called a TNF-blocker. SIMPONI ARIA is used to treat: Adults with the medicine methotrexate (MTX) to treat moderately to severely active RA. Active psoriatic arthritis (PsA) in people 2 years of age and older.

Adults with active ankylosing spondylitis (AS). Active polyarticular juvenile idiopathic arthritis (pJIA) in people 2 years of age and older. It is not known if SIMPONI ARIA is safe and effective in children with PsA and pJIA under 2 years of age or in children with conditions other than PsA and pJIA.

Side effects, and when to stop

SIMPONI ARIA can cause serious side effects, including: Serious Infections. Some patients have an increased chance of getting serious infections while receiving SIMPONI ARIA. 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 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 ARIA: 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 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 SIMPONI ARIA.

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

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 SIMPONI ARIA, your condition should be watched closely during treatment with SIMPONI ARIA. Call your doctor right away if you get new or worsening symptoms of heart failure during treatment with SIMPONI ARIA (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 SIMPONI ARIA, 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 SIMPONI ARIA. 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

What to say before you start

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 SIMPONI ARIA 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. 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. are pregnant or plan to become pregnant. It is not known if SIMPONI ARIA will harm your unborn baby. 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 SIMPONI ARIA or breastfeed. 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 ORENCIA (abatacept) or KINERET (anakinra).

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.

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 SIMPONI ARIA you will receive. Your usual schedule for receiving SIMPONI ARIA after your first treatment should be: 4 weeks after your first treatment every 8 weeks after that If you miss an appointment to receive SIMPONI ARIA, make another appointment as soon as possible.