"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 Consumer (continued)
Headache, stomach pain, or nausea may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: pain/swelling at injection site, joint/muscle pain, swelling ankles/feet, easy bruising/bleeding, vision changes, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, chest pain, pain/redness/swelling of arms or legs, shortness of breath, fast/slow/irregular heartbeat.
Tell your doctor immediately if you develop signs of infection while using this drug, such as: fever, chills, night sweats, persistent cough, persistent sore throat, trouble breathing, painful/frequent urination, unusual vaginal discharge, white patches in the mouth (oral thrush).
This drug may rarely cause serious (possibly fatal) liver disease. Most cases occur 2 weeks to more than a year after starting infliximab. Tell your doctor immediately if you develop symptoms of liver disease, including dark urine, extreme tiredness, severe stomach/abdominal pain, or yellowing eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, difficulty swallowing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Remicade (infliximab) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using infliximab, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: previous severe allergic reaction to this medication, tuberculosis (previous infection or positive skin test), past/recent/current infections (e.g., cold sores, Valley Fever), heart disease (e.g., heart failure), blood/bone marrow disorder (e.g., leukopenia, thrombocytopenia), nervous system disorder (e.g., numbness/tingling, seizures, multiple sclerosis), history of cancer (e.g., breast cancer, skin cancer, lymphoma), certain lung disorder (chronic obstructive pulmonary disease-COPD), liver disease (e.g., hepatitis B), light treatment for psoriasis (phototherapy).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Infliximab can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
It is recommended that children get all their vaccinations before starting this medication.
Older adults may be more sensitive to the side effects of this drug, especially risk for infections.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Mothers who have used this medication during pregnancy should ask a doctor about immunizations/vaccinations for their newborn babies.
It is unknown if this medication passes into breast milk. However, it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.
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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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