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|Infliximab

Infliximab

Infliximab is used for:

Reducing signs and symptoms of moderate to severe rheumatoid arthritis in combination with another medicine called methotrexate. It may be used to treat ankylosing spondylitis and moderate to severe Crohn disease in patients who have not received relief from other treatments. It may also be used to treat 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). Blocking TNF may reduce the inflammation and immune responses caused by too much TNF in the body.

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 , or if you have an infection
• you are using anakinra injections

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 a history of chronic or recurrent infection, TB, hepatitis, liver problems, fungal infection (eg, histoplasmosis, coccidioidomycosis), heart problems (eg, congestive heart failure), blood disorders or problems, lymphoma or other cancer, or seizures
• if you have nervous system problems (eg, multiple sclerosis, Guillain-Barré syndrome, CNS demyelinating disease)
• if you recently received or are scheduled to receive a vaccine

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

• 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 additional patient leaflet. Read it carefully.
• Infliximab is usually administered as an injection at your doctor"s office, hospital, or clinic. If you are using Infliximab at home, carefully follow the injection procedures taught to you by your health care provider.
• If Infliximab contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• 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. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Infliximab . Using Infliximab alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Infliximab .
• If you live in or have recently visited an area where histoplasmosis or coccidioidomycosis infections are common, inform your doctor. Ask your doctor if you have questions about whether these infections are common in a particular area.
• Infliximab may lessen your body"s ability to fight infection. It can make you more prone to getting infections or it can make an infection you already have worse. Prevent infection by avoiding contact with people with colds or other 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 you experience any of these symptoms, contact your doctor at once.
• Infliximab may make you more prone to developing lymphoma (blood cancer). Tell your doctor if you have ever had lymphoma or if any other new symptoms appear, such as a lump or swelling in your neck, armpit, or groin; excessive sweating; fever; unusual tiredness; unexplained cough or breathlessness; or persistent itching.
• If you have heart failure and you are being treated with Infliximab , you will be closely monitored by your doctor. If you develop shortness of breath or swelling of your ankles or feet, contact your doctor at once.
• LAB TESTS, including liver function tests, may be required to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Caution is advised when using Infliximab in the ELDERLY because they may be more sensitive to its effects, especially the risk of infection.
• Infliximab is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you plan on becoming pregnant, discuss with your doctor the benefits and risks of using Infliximab during pregnancy. It is unknown if Infliximab is excreted 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; bronchitis; diarrhea; indigestion; mouth sores; nausea; pain, redness, or swelling at the injection site; runny nose; sinus inflammation; tiredness; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chest pain; chills; cough; dark brown-colored urine; difficulty swallowing; dizziness; easy bruising or bleeding; fainting; fever; flu-like symptoms; headache; itching; joint or muscle pain; numbness or tingling in any part of the body; painful urination or change in the amount of urine produced; pale skin; pounding in the chest; rash on the cheeks or arms that gets worse in the sun; seizures; severe tiredness; shortness of breath; sore throat; stomach pain; swelling of the legs or ankles; unexplained loss of weight or appetite; unusual lumps; unusual vaginal discharge; upper respiratory tract infection; urinary tract infection; weakness in arms and/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 or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Store this medicine in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. 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.