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 Remsima (Infliximab).
Allergic reactions: In rare cases, some people may develop an allergic reaction to Remsima (Infliximab). 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 Remsima (Infliximab) 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 Remsima (Infliximab).
Cancer: Compared to the general population, people taking Remsima (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 Remsima (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 Remsima (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, such as cervical and certain skin cancers, have also been seen in people who are taking Remsima (Infliximab). Talk to your doctor about the risks and benefits of using Remsima (Infliximab).
Heart failure: Remsima (Infliximab) may worsen congestive heart failure. If you have mild heart failure you should be closely monitored by your doctor while taking Remsima (Infliximab). 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 Remsima (Infliximab).
Hepatitis B: People infected with hepatitis B (an infection that can damage the liver) may have a relapse of their condition while taking Remsima (Infliximab). If you are at risk for hepatitis B, your doctor may want to test you for this infection before starting treatment with Remsima (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 Remsima (Infliximab) 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: Remsima (Infliximab) can increase the risk of developing an infection, including serious infections such as sepsis, pneumonia, and tuberculosis. Before starting Remsima (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. Remsima (Infliximab) 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 Remsima (Infliximab), your doctor will monitor you for signs of infection.
Liver problems: Very rarely, people taking Remsima (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, Remsima (Infliximab) 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 Remsima (Infliximab), contact your doctor immediately.
Vaccines: Live vaccines (e.g., BCG, yellow fever) are not recommended for people taking Remsima (Infliximab). Talk to your doctor if you need any vaccinations while taking Remsima (Infliximab). Children with Crohn's should complete the recommended vaccination schedule before receiving their first dose of Remsima (Infliximab).
Pregnancy: Remsima (Infliximab) is not recommended for use during pregnancy as it crosses the placenta and the effects on the developing baby are not known. Women who may become pregnant should use an effective method of birth control while they are taking Remsima (Infliximab) and for at least 6 months after the last treatment.
Breast-feeding: It is not known if Remsima (Infliximab) passes into breast milk. Women should not breast-feed while they are taking Remsima (Infliximab) and should not start breast-feeding until at least 6 months after the last treatment.
Children: The safety and effectiveness of Remsima (Infliximab) have not been established for children.
Seniors: Seniors may be more likely to experience serious infections with Remsima (Infliximab). Talk to your doctor about the risks and benefits of using Remsima (Infliximab).
