Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
HEALTH CANADA ADVISORY
August 20, 2009
Health Canada issued an advisory concerning the use of Remicade® (infliximab). To read the full Health Canada Advisory, visit Health Canada's web site at www.hc-sc.gc.ca.
A previous advisory was issued on July 24, 2006, and can be accessed at www.hc-sc.gc.ca.
Allergic reactions: In rare cases, some people may develop an allergic reaction to this medication. Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, contact your doctor immediately.
Blood disorders: Rarely, people taking this medication have become deficient in certain types of blood cells. This may lead to problems with blood clotting, the immune system, or the transport of oxygen through the body. Contact your doctor immediately if you develop a fever, easy bruising, paleness, or bleeding while taking this medication.
Cancer: Compared to the general population, people taking infliximab have a slightly greater risk of developing a cancer of the immune system (known as lymphoma). However, the risk of developing this type of cancer is still rare.
In general, people with severe rheumatoid arthritis and Crohn's disease who take medications that suppress the immune system over long periods of time may also have a higher risk of developing lymphoma, even if they don't take infliximab. Contact your doctor if you develop symptoms of lymphoma (such as fatigue, weight loss, fever, swollen glands, night sweats, and itching). (Note though that these may also be symptoms of other conditions.)
Some children and young adults with Crohn's disease who were receiving infliximab have developed hepatosplenic T-cell lymphoma, a rare type of cancer that is often fatal. Talk to your doctor if you have any concerns.
Other forms of cancer (e.g., non-lymphoma cancers) have also been seen in people who are taking infliximab. Talk to your doctor about the risks and benefits of using this medication.
Heart failure: This medication may worsen congestive heart failure. If you have mild heart failure you should be closely monitored by your doctor while taking this medication. If you notice symptoms of congestive heart failure (such as swelling of the hands or feet and difficulty breathing), contact your doctor immediately. People with moderate or severe congestive heart failure should not take infliximab.
Hepatitis B: People infected with hepatitis B (an infection that can damage the liver) may have a relapse of their condition while taking this medication. If you are at risk for hepatitis B, your doctor may want to test you for this infection before starting treatment with infliximab and will follow your condition closely while you are taking the medication. If you notice symptoms of a liver problem (see below), contact your doctor immediately.
Immune system disorders: Some people who take this medication have developed lupus-like syndrome, an autoimmune disease (a condition where the body is attacked by its own immune system). Symptoms of lupus-like syndrome include chest pain, joint pain, difficulty breathing, and a skin rash (usually on the cheeks and arms) that is sensitive to the sun. If you develop these symptoms, contact your doctor as soon as possible.
Infections: This medication can increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and tuberculosis. Before starting infliximab treatment, your doctor may test to see if you have tuberculosis. If you notice signs of an infection such as fever, chills, pain, swelling, coughing or pus, contact your doctor as soon as possible. This medication should also not be started while you have an active infection.
Tell your doctor if you have a history of infections that keep coming back, or other conditions that might increase your risk of infections (e.g., diabetes) or have visited or lived in areas where there is a greater risk of certain kinds of fungal infection (e.g., blastomycosis). While you are taking infliximab, your doctor will monitor you for signs of infection.
Liver problems: Very rarely, people taking infliximab may experience liver problems. Symptoms of liver problems include abdominal pain, dark urine, fatigue, loss of appetite, and yellow eyes or skin. If you notice these symptoms, contact your doctor immediately.
Nervous system disorders: Rarely, this medication may increase the risk of problems with the nervous system or cause existing problems to get worse. If you experience confusion, seizures, vision changes, tingling or numbness, or weakness in your arms or legs while taking this medication, contact your doctor immediately.
Vaccines: Live vaccines (e.g., BCG, yellow fever) are not recommended for people taking this medication. Talk to your doctor if you need any vaccinations while taking this medication. Children with Crohn's should complete the recommended vaccination schedule before receiving their first dose of infliximab.
Pregnancy: This medication is not recommended for use during pregnancy. Women who may become pregnant should use an effective method of birth control while they are taking this medication and for at least 6 months after the last treatment.
Breast-feeding: It is not known if infliximab passes into breast milk. Women should not breast-feed while they are taking this medication and should not start breast-feeding until at least 6 months after the last treatment.
Children: The safety and effectiveness of this medication have not been established for children under 6 years old. It can be used to treat children 6 years and older who have moderate-to-severe ulcerative colitis. It can also be used to treat children 9 years and older who have moderate-to-severe Crohn's disease. The safety and effectiveness of this medication for treating other conditions in children have not been established.
Seniors: Seniors may be more likely to experience serious infections with infliximab. Talk to your doctor about the risks and benefits of using this medication.