Generic Name: infliximab (in-FLIX-i-mab)
Brand Name: Remicade
Patients who use infliximab have an increased risk of developing serious and sometimes fatal infections (eg, bacterial, viral, or fungal infections; tuberculosis [TB]). Most patients who developed these infections were taking medicines that suppressed their immune systems (eg, methotrexate, corticosteroids).
TB may be caused by a new infection or by reactivation of a previous infection. You should be tested for TB infection before you start infliximab. If you have a TB infection, treatment for TB should be started before you begin infliximab. Tell your doctor right away if you develop symptoms of infection, such as fever, chills, persistent cough or sore throat, unusual vaginal discharge, painful or frequent urination, or a persistent feeling of being unwell. Tell your doctor if you have a history of chronic or recurrent infections.
Infliximab is a tumor necrosis factor (TNF) blocker. Lymphoma and other types of cancer have been reported in children and teenagers treated with TNF blockers. This has been fatal in some cases. Talk with your doctor for more information.
A rare type of cancer called hepatosplenic T-cell lymphoma (HSTCL) has rarely occurred in teenagers and young adults using TNF blockers, including infliximab. These cases have been fatal. Almost all patients who developed this cancer were using this type of medicine along with certain other medicines (azathioprine or 6-mercaptopurine). Most of the time, people were being treated for Crohn's disease or ulcerative colitis. Also, most cases were in teenage or young adult males. Tell your doctor if you have or have ever had any type of cancer.
Infliximab is used for:
Treating moderate to severe rheumatoid arthritis when used along with another medicine (methotrexate). It is also used to treat ankylosing spondylitis, psoriatic arthritis, and certain types of skin psoriasis (eg, plaque psoriasis). Infliximab is used to treat moderate to severe Crohn disease or ulcerative colitis in certain patients who have not received relief from other treatments. It may also be used for other conditions as determined by your doctor.
Infliximab is a monoclonal antibody. It works by blocking the action of a substance in the body called TNF. This may reduce the inflammation and immune responses caused by TNF.
Do NOT use infliximab if:
- you are allergic to any ingredient in infliximab, including mouse-derived (murine) proteins
- you have moderate to severe heart failure, unless your doctor has examined you and decided that you are able to take infliximab. Certain doses of infliximab should not be used in patients who have moderate to severe heart failure. Ask your doctor if you have questions about this information
- you have an active infection
- you are using abatacept, adalimumab, anakinra, canakinumab, certolizumab, etanercept, rilonacept, rituximab, tocilizumab, or tofacitinib
Contact your doctor or health care provider right away if any of these apply to you.
Before using infliximab:
Some medical conditions may interact with infliximab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have any type of infection, including bacterial or viral infection, fungal infection (eg, coccidiomycosis, histoplasmosis), TB infection, skin infection, or open cuts or sores on your body
- if you have a history of chronic or recurrent infections, TB or a positive TB skin test, or if you have recently been around someone who has had TB
- if you have conditions that may increase your risk of infection (eg, diabetes) or if you have traveled to or lived in an area where TB or other certain infections (eg, histoplasmosis, coccidioidomycosis, blastomycosis) are common
- if you have a history of immune system problems (eg, weakened immune system), blood problems, bone marrow problems, or lymphoma or other cancers
- if you have a history of liver problems (eg, hepatitis B), liver problems caused by drinking alcohol (alcoholic hepatitis), or hepatitis B virus reactivation when taking infliximab or other TNF blockers
- if you have any numbness or tingling or a disease that affects your nervous system (eg, multiple sclerosis [MS], Guillain-BarrÃ© syndrome, seizures)
- if you have heart problems (eg, congestive heart failure)
- if you have had phototherapy to treat psoriasis or other skin conditions
- if you have recently received or are scheduled to receive a vaccine
- if you have chronic obstructive pulmonary disease (COPD) or a history of smoking
- if you have been taking another medicine to treat rheumatoid arthritis
Some MEDICINES MAY INTERACT with infliximab. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Abatacept, adalimumab, anakinra, canakinumab, certolizumab, etanercept, rilonacept, rituximab, tocilizumab, or tofacitinib because the risk of serious infection may be increased
- Anticoagulants (eg, warfarin), cyclosporine, or theophylline because their effectiveness may be decreased by infliximab
This may not be a complete list of all interactions that may occur. Ask your health care provider if infliximab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use infliximab:
Use infliximab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Infliximab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get infliximab refilled.
- Infliximab is given as an injection at your doctor's office, hospital, or clinic. Contact your health care provider if you have any questions.
- You may receive other medicines before each treatment with infliximab to decrease the chance of an infusion-related reaction. Discuss any questions with your doctor.
- If you miss a dose of infliximab, contact your doctor right away.
Ask your health care provider any questions you may have about how to use infliximab.
Important safety information:
- Infliximab may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use infliximab with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not receive a live vaccine (eg, measles, mumps) or treatment with a weakened bacteria (eg, BCG for bladder cancer) while you are using infliximab. Talk with your doctor before you receive any vaccine.
- Before you use infliximab, discuss your vaccination history with your doctor to be sure that you are up to date on vaccinations.
- Tell your doctor or dentist that you take infliximab before you receive any medical or dental care, emergency care, or surgery.
- Infliximab may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first. If you develop a fever, feel very tired, have a cough, or have flu-like symptoms, these could be signs that you may be getting an infection. If any of these symptoms occur, contact your doctor at once.
- Infliximab may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
- Infliximab may increase the risk of developing a certain type of blood cancer (lymphoma) or other types of cancer (eg, skin cancer). The risk may increase if you have used infliximab for a long time. Tell your doctor if you have ever had lymphoma or another cancer, or if you have a risk of developing cancer. Contact your doctor right away if any symptoms appear, such as unusual lumps or swelling (eg, in your armpit, groin, or neck), night sweats, recurring fever, unusual tiredness, unexplained cough or breathlessness, persistent unexplained itching, or unexplained weight loss.
- New or worsening nervous system disorders (eg, MS, Guillain-BarrÃ© syndrome, seizures) have occurred in patients who take infliximab. Tell your doctor if you have a disease that affects your nervous system. Discuss any questions or concerns with your doctor.
- Some patients who use infliximab have developed new or worsening psoriasis. Tell your doctor right away if you notice any new or worsening skin problems (eg, red, flaky, or itchy skin patches).
- Rarely, severe liver problems have occurred with the use of infliximab. These liver problems may occur from 2 weeks to more than a year after starting infliximab. Contact your doctor right away if you develop dark urine, pale stools, severe or persistent stomach pain, or yellowing of the skin or eyes.
- Some patients receiving infliximab have experienced an allergic reaction. Some allergic reactions have been severe. If such a reaction occurs, it has usually happened during treatment with infliximab or within 2 hours after treatment. However, allergic reactions have also occurred up to 12 days after the use of infliximab. Tell your doctor if symptoms such as fever, chills, rash, hives, headache, dizziness, chest pain, muscle or joint pain, swelling, sore throat, or trouble breathing or swallowing occur.
- Rarely, temporary vision loss or a heart attack have been reported during treatment with infliximab or within 2 hours after treatment. Tell your doctor right away if you experience vision loss or other vision changes; chest pain; numbness of an arm or leg; sudden, severe headache or vomiting; or fainting.
- If you used infliximab during pregnancy, tell your baby's doctor. Your baby may have a higher risk of getting an infection for at least 6 months after birth. Your baby's doctor will also need to decide when your baby should receive any vaccine. Certain vaccines may cause infections.
- Infliximab may interfere with certain lab tests, including tests for TB infection. Be sure your doctor and lab personnel know you are using infliximab.
- Lab tests, including TB, liver function, and complete blood cell counts, may be performed while you use infliximab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use infliximab with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of infection.
- Caution is advised when using infliximab in CHILDREN; they may be more likely to develop certain side effects. These effects may include certain blood problems (eg, anemia, low white blood cell levels), blood in the stool, flushing, bone fracture, certain types of infection, and certain allergic reactions. Cases of unusual cancer have occurred in children and teenagers using infliximab.
- PREGNANCY and BREAST-FEEDING: It is not known if infliximab can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using infliximab while you are pregnant. It is not known if this medicine is found in breast milk. Do not breast-feed while taking infliximab.
Possible side effects of infliximab:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Back pain; headache; mild stomach pain or upset; pain, redness, or swelling at the injection site; runny or stuffy nose; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody, black, or tarry stools; butterfly-shaped rash on the nose and cheeks; change in the amount of urine produced; change in the appearance of a mole; chest pain; dark urine; dizziness; fainting; fast, slow, or irregular heartbeat; flushing; joint or muscle pain; loss of appetite; nausea, vomiting, or diarrhea; numbness or tingling of the skin, arms, or legs; pale stools; red, swollen, blistered, or peeling skin; seizures; severe or persistent headache; severe or persistent stomach or back pain; shortness of breath; sudden, unexplained weight gain or loss; suicidal thoughts or attempts; swelling of the hands, legs, feet, or ankles; symptoms of infection (eg, fever or chills, painful or frequent urination, persistent cough or sore throat, flu-like symptoms, persistent feeling of being unwell, unusual vaginal discharge or odor, white patches in the mouth, red or painful skin); trouble swallowing; unusual bruising or bleeding; unusual lumps; unusual skin growths or other skin changes; unusual tiredness or weakness; very pale skin; vision changes; weakness in the arms or legs; yellowing of the skin or eyes.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of infliximab:
Infliximab will be handled and stored by a health care provider. You will not store it at home. Keep all medicines out of the reach of children and away from pets.
- If you have any questions about infliximab, please talk with your doctor, pharmacist, or other health care provider.
- Infliximab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take infliximab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about infliximab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to infliximab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using infliximab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.