This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (e.g., fungal infections, tuberculosis). You should have a tuberculosis (TB) skin test before starting this medication. Also tell your doctor your medical history, especially of past/recent/current infections. You should also tell your doctor if you have lived or traveled in areas where certain infections (e.g., coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis.

In patients taking infliximab along with azathioprine or 6-mercaptopurine for the treatment of Crohn's disease, there have been rare reports of an extremely rare, often fatal cancer (hepatosplenic T-cell lymphoma). Tell your doctor immediately if you develop symptoms such as fever, night sweats, unusual tiredness, loss of appetite, unexplained weight loss, or swollen lymph nodes.

See also Side Effects.

This medication is used to treat certain types of arthritis (rheumatoid arthritis, arthritis of the spine, psoriatic arthritis), certain bowel diseases (Crohn's disease, ulcerative colitis), and a certain severe skin disease (chronic plaque psoriasis). In these conditions, the body's defense system (immune system) attacks healthy tissues. Infliximab works by blocking the actions of a certain natural substance (tumor necrosis factor alpha) in the body. This helps to decrease swelling (inflammation) and weaken your immune system, thereby slowing or stopping the damage from the disease.

Read the Medication Guide provided by your pharmacist before you start using infliximab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

This medication is given by injection into a vein over at least 2 hours by a health care professional. The dosage is based on your medical condition, weight, and response to treatment. After the first dose, this medication is usually given again after 2 weeks and 6 weeks, then every 8 weeks thereafter (every 6 weeks for arthritis of the spine) or as directed by your doctor.

Your doctor may direct you to use other medications (to help prevent side effects) before using infliximab. Use those medications exactly as directed.

Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.

Tell your doctor if your condition persists or worsens.

See also Warning section.

Headache, stomach pain, or nausea may occur. If this effect persists or worsens, 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 immediately if any of these unlikely but serious side effects occur: pain/swelling at injection site, joint/muscle pain.

Tell your doctor immediately if any of these rare but very serious side effects occur: 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.

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.

Because infliximab works by blocking the immune system, it may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor immediately if you have any signs of infection (e.g., cough, cold, sore throat, fever, chills).

The immune system is also important in preventing and controlling cancer. Though very unlikely, you may have a slightly increased risk of developing cancer (e.g., lymphoma) with this medication. Tell your doctor immediately if you develop symptoms such as: unusual lumps/growths, swollen glands, night sweats, changes in skin appearance, unexplained weight loss.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

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 medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: previous severe allergic reaction to this medication.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: 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 that you are using this medication.

Since this medication can increase your risk of developing serious infections, wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

It is recommended that children get all their vaccinations before starting this medication.

The elderly may be at greater risk for infections while using this drug.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: abatacept, anakinra, live vaccines.

Do not mix infliximab with other medications in the same IV bag or infuse together through the same IV line as other medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., complete blood count, liver function test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

Store the vials of powder in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light. Do not freeze. After the medication has been mixed and diluted, the infusion should start within 3 hours. Throw away any unused medication after that time. Do not save for later use. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Information last revised June 2009 Copyright(c) 2009 First DataBank, Inc.