Infliximab

Infliximab is used for:

Reducing signs and symptoms of moderate to severe rheumatoid arthritis when used along with another medicine (methotrexate). It is also used to reduce symptoms of moderate to severe ankylosing spondylitis, psoriatic arthritis, and certain types of skin psoriasis. Infliximab is used to reduce symptoms of moderate to severe Crohn disease or ulcerative colitis in 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 blocks the action of a substance in the body called tumor necrosis factor (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 and you need doses higher than 5 mg/kg of Infliximab
• if you have an active serious infection
• you are taking anakinra

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, skin infection, fungal infection (eg, histoplasmosis, coccidiomycosis), or TB infection, or have a history of chronic or recurrent infections, a positive TB test, or if you have recently been around someone who might have TB
• if you were born in an area where TB is common or if you have visited or lived in an area where TB, histoplasmosis, or coccidiomycosis infections are common
• if you have a history of hepatitis B or other liver problems, heart problems (eg, congestive heart failure), nervous system problems (eg, seizures, multiple sclerosis, Guillain-Barre syndrome, CNS demyelinating disease), blood disorders, bone marrow problems, lymphoma, or cancer
• 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

Some MEDICINES MAY INTERACT with Infliximab . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Costimulation modulators (eg, abatacept), immunosuppressants (eg, cyclosporine), or interleukin-1 receptor antagonists (eg, anakinra) because side effects, such as increased risk of severe infection and low white blood cells counts, may occur

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 usually given as an injection at your doctor's office, hospital, or clinic.
• If you miss a dose of Infliximab , contact your doctor immediately.

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) while you are taking Infliximab . Talk with your doctor before you receive any vaccine.
• Tell your doctor if you live in or have recently visited an area where histoplasmosis or coccidioidomycosis infections are common. Ask your doctor if you have questions about whether these infections are common in a particular area.
• 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 lymphoma (blood cancer) or other cancer. Tell your doctor if you have ever had lymphoma or another cancer. Contact your doctor right away if any symptoms appear, such as unusual lumps or swelling (eg, in your neck, armpit, or groin), night sweats, recurring fever, unusual tiredness, unexplained cough or breathlessness, persistent unexplained itching, or unexplained weight loss.
• Rarely, severe liver problems have occurred with use of Infliximab . These liver problems may occur more than a year after starting Infliximab . Contact your doctor right away if you develop dark urine, severe or persistent stomach pain, or yellowing of the skin or eyes.
• Allergic reactions have occurred up to 12 days after the use of Infliximab . Tell your doctor if symptoms such as fever, rash, headache, or muscle or joint pain occur.
• Lab tests, including 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.
• Infliximab should be used with extreme caution for Crohn disease in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
• Infliximab should be used with extreme caution for other diseases in CHILDREN; safety and effectiveness for other diseases in children have not been confirmed.
• Children may be more sensitive to Infliximab 's effects, especially blood problems, infection, blood in the stool, flushing, and certain allergic reactions.
• 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 Infliximab 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:

Back pain; headache; pain, redness, or swelling at the injection site; runny or stuffy nose; stomach pain or upset; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); change in the amount of urine produced; chest pain; cough; dark brown-colored urine; dizziness; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; flu-like symptoms; flushing; joint or muscle pain; numbness or tingling of the skin, arms, or legs; painful urination; rash on the cheeks or arms that gets worse in the sun; red, warm, or painful skin; seizures; severe or persistent stomach or back pain; severe tiredness or weakness; shortness of breath; sudden unexplained weight gain or loss; suicidal thoughts or attempts; swelling of the hands, legs, or ankles; trouble swallowing; unexplained loss of appetite; unusual bruising or bleeding; unusual lumps; unusual vaginal discharge or odor; upper respiratory tract infection; very pale skin; vision changes; weakness in arms or legs; white patches or sores in the mouth; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately.

Infliximab is usually handled and stored by a health care provider. If you are using Infliximab at home, store Infliximab as directed by your pharmacist or health care provider. Keep Infliximab out of the reach of children and away from pets.

General information:

• 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.

This information is a summary only. It does not contain all information about Infliximab . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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