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Infliximab

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Medical Alert

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Warning

This medication can decrease your body's ability to fight an infection. This effect can lead to very serious (possibly fatal) infections (such as fungal infections, bacterial infections including tuberculosis). You should have a tuberculosis (TB) skin test before and during treatment with 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 fungal infections (such as coccidioidomycosis, histoplasmosis) are common or if you have been near someone with tuberculosis. Areas where these types of fungal infections are commonly found include the Ohio and Mississippi River valleys and the southwestern United States. See Side Effects section for symptoms of infections to watch out for, and get medical help right away if you have any of these symptoms.

The immune system also helps prevent and control cancer. There is a very small risk (especially in children/teens/young adults) of developing cancer (such as lymphoma, skin cancer) due to this medication or due to your medical condition. A rare, mostly fatal cancer (hepatosplenic T-cell lymphoma) has occurred in people receiving this medication along with certain other drugs (azathioprine or 6-mercaptopurine) to treat Crohn's disease or ulcerative colitis. Talk to your doctor about the risks and benefits of treatment. Tell your doctor right away if you have symptoms such as unusual lumps/growths, swollen glands, swollen or painful abdomen, unexplained weight loss, unusual tiredness, loss of appetite, fever that doesn't go away, or night sweats.

Precautions

Before using infliximab, tell your doctor or pharmacist if you are allergic to it; or to other infliximab products; 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: tuberculosis (previous infection or positive skin test), past/recent/current infections (such as cold sores, valley fever), heart disease (such as heart failure), blood/bone marrow disorder (such as leukopenia, thrombocytopenia), nervous system disorder (such as numbness/tingling, seizures, multiple sclerosis), cancer (such as breast cancer, skin cancer, lymphoma), a certain lung disorder (chronic obstructive pulmonary disease-COPD), liver disease (such as 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. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Call your doctor if you have been exposed to an infection or for more details.

Tell your health care professional that you are using infliximab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Older adults may be more sensitive to the side effects of this drug, especially risk for infections.

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using infliximab. Infliximab may harm an unborn baby. Ask about reliable forms of birth control while using this medication and for 6 months after the last dose. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. If this medication is used during pregnancy, be sure to tell your baby's doctors about its use. The doctor may change the baby's vaccination schedule to decrease the risk of infection.

This drug may pass into breast milk, but it is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

Side Effects

See also Warning and How to Use section.

Headache, stomach pain, or nausea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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: joint/muscle pain, easy bruising/bleeding, seizures, confusion, muscle weakness, numbness/tingling of arms/legs, butterfly-shaped facial rash, pain/redness/swelling of arms or legs, new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).

Tell your doctor right away if you develop signs of infection while using this drug, such as: cough/sore throat that doesn't go away, fever, chills, night sweats, 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. Get medical help right away if you have any symptoms of liver damage, such as: extreme tiredness, nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication may cause serious heart problems (such as heart attack) during the infusion and up to 24 hours after the start of the infusion. Get medical help right away if you have any symptoms of heart problems such as chest/jaw/left arm pain, shortness of breath, unusual sweating, lightheadedness, dizziness, fainting, vision changes, or fast/irregular/slow heartbeat.

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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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