"The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy.
Remicade Patient Information Including Side Effects
Brand Names: Remicade
Generic Name: infliximab (Pronunciation: in FLIX ih mab)
- What is infliximab (Remicade)?
- What are the possible side effects of infliximab (Remicade)?
- What is the most important information I should know about infliximab (Remicade)?
- What should I discuss with my healthcare provider before using infliximab (Remicade)?
- How should I use infliximab (Remicade)?
- What happens if I miss a dose (Remicade)?
- What happens if I overdose (Remicade)?
- What should I avoid while using infliximab (Remicade)?
- What other drugs will affect infliximab (Remicade)?
- Where can I get more information?
What is infliximab (Remicade)?
Infliximab reduces the effects of a substance in the body that can cause inflammation.
Infliximab is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, Crohn's disease, and ankylosing spondylitis. Infliximab is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin).
Infliximab is often used when other medicines have not been effective.
Infliximab may also be used for purposes not listed in this medication guide.
What are the possible side effects of infliximab (Remicade)?
Some people receiving an infliximab injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, nauseated, light-headed, itchy or tingly, swollen, short of breath, or have a headache, fever, chills, flu symptoms, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using infliximab and call your doctor right away if you have any of these symptoms of lymphoma:
- fever, night sweats, weight loss, tiredness;
- feeling full after eating only a small amount;
- pain in your upper stomach that may spread to your shoulder;
- easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Call your doctor at once if you have any of these other serious side effects:
- signs of infection (fever, chills, flu symptoms, confusion, or pain, warmth, or redness of your skin);
- chest pain, ongoing cough, coughing up mucus or blood;
- shortness of breath with swelling of your ankles or feet, rapid weight gain;
- numbness or tingling;
- easy bruising or bleeding, pale skin, unusual weakness;
- weak feeling in your arms or legs;
- problems with vision;
- neck stiffness, seizure (convulsions);
- pain or burning when you urinate; or
- red, purple, or scaly skin rash, hair loss, joint or muscle pain, mouth sores.
Less serious side effects may include:
- stuffy nose, sinus pain, headache;
- mild stomach pain;
- mild skin rash; or
- flushing (warmth, redness, or tingly feeling).
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the Remicade (infliximab) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about infliximab (Remicade)?
You should not use this medication if you are allergic to infliximab, or if you are also being treated with anakinra (Kineret) or abatacept (Orencia).
Some people using infliximab have developed a rare fast-growing type of lymphoma (cancer). This condition affects the liver, spleen, and bone marrow, and it can be fatal. This has occurred mainly in teenagers and young adults using infliximab or similar medicines to treat Crohn's disease or ulcerative colitis.
Call your doctor at once if you have any of the following symptoms: fever, night sweats, itching, loss of appetite, weight loss, tiredness, feeling full after eating only a small amount, pain in your upper stomach that may spread to your shoulder, nausea, easy bruising or bleeding, pale skin, feeling light-headed or short of breath, rapid heart rate, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Infliximab can lower blood cells that help your body fight infections. Your blood may need to be tested often. Avoid being near people who are sick or have infections. Avoid activities that may increase your risk of bleeding injury. Serious and sometimes fatal infections may occur during treatment with infliximab. Contact your doctor right away if you have signs of infection such as: fever, chills, flu symptoms, or pain, warmth, or redness of your skin.
Before you receive infliximab, tell your doctor if you have heart failure or other heart problems, an active or recent infection, diabetes, liver disease, seizures, chronic obstructive pulmonary disease (COPD), a history of cancer, a weak immune system, numbness or tingling, a nerve or muscle disorder, or if you have recently received a vaccine.
Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.
Some infections are more likely to occur in certain areas of the world. Tell your doctor where you live and where you have recently traveled or plan to travel to during treatment.
Do not receive a "live" vaccine while you are being treated with infliximab.
Additional Remicade Information
- Remicade Drug Interactions Center: infliximab iv
- Remicade Side Effects Center
- Remicade Overview including Precautions
- Remicade FDA Approved Prescribing Information including Dosage
Remicade - User Reviews
Remicade User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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