Golimumab Injection

Using golimumab injection may decrease your ability to fight infection and increase the risk that you will get a serious infection, including severe fungal, bacterial, or viral infections that spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) and chronic infections that do not go away. Also tell your doctor if you have or have ever had diabetes, human immunodeficiency virus (HIV) , acquired immunodeficiency syndrome (AIDS), or any other condition that affects your immune system. You should also tell your doctor if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you are not sure if these infections are common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system such as the following: abatacept (Orencia); anakinra (Kineret); methotrexate (Rheumatrex); rituximab (Rituxan); steroids including dexamethasone, methylprednisolone (Medrol), prednisolone (Prelone) and prednisone; tocilizumab (Actemra); and other TNF-blockers such as adalimumab (Humira), certolizumab (Cimzia), etanercept (Enbrel), and infliximab (Remicade).

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; sore throat; cough; coughing up bloody mucus; fever; weight loss; extreme tiredness; diarrhea; stomach pain; warm, red, or painful skin; sores on the skin; painful, difficult, or frequent urination; or other signs of infection.

You may be infected with tuberculosis (TB, a type of lung infection) or hepatitis B (a type of liver disease) but not have any symptoms of the disease. In this case, golimumab injection may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order blood tests to see if you have an inactive hepatitis B infection. If necessary, your doctor will give you medication to treat this infection before you start using golimumab injection. Tell your doctor if you have or have ever had TB or hepatitis B, if you have visited any country where TB is common, or if you have been around someone who has TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, or fever. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some children, teenagers, and young adults who received golimumab injection and similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took golimumab or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with golimumab or a similar medication along with another medication called azathioprine (Imuran) or 6-mercaptopurine (Purinethol). Children and teenagers should not normally receive golimumab injection, but in some cases, a doctor may decide that golimumab injection is the best medication to treat a child’s condition. If golimumab injection is prescribed for your child, you should talk to your child’s doctor about the risks and benefits of using this medication. If your child develops any of these symptoms during his treatment, call his doctor immediately: unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with golimumab injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm)or the manufacturer’s website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving golimumab injection.