warnings

What is the most important information I should know about Infliximab (Intravenous)?

You should not be treated with infliximab if you are allergic to it.

Tell your doctor if you have ever had tuberculosis (TB) or if anyone in your household has tuberculosis. Also tell your doctor if you have recently traveled. Tuberculosis and some fungal infections are more common in certain parts of the world, and you may have been exposed during travel.

Tell your doctor if you have ever had:

an active infection (fever, cough, flu symptoms, open sores or skin wounds);
heart failure or other heart problems;
diabetes;
a weak immune system;
liver failure, hepatitis B, or other liver problems;
chronic obstructive pulmonary disease (COPD);
heart problems;
cancer;
seizures;
numbness or tingling anywhere in your body;
a nerve-muscle disorder, such as multiple sclerosis or Guillain-Barré syndrome;
phototherapy for psoriasis;
vaccination with BCG (Bacille Calmette-Guérin); or
if you are scheduled to receive any vaccines.

Make sure your child is current on all vaccines before he or she starts treatment with infliximab.

Infliximab may cause a rare type of lymphoma (cancer) of the liver, spleen, and bone marrow that can be fatal. This has occurred mainly in teenagers and young men with Crohn's disease or ulcerative colitis. However, anyone with an inflammatory autoimmune disorder may have a higher risk of lymphoma. Talk with your doctor about your own risk.

Infliximab may cause other types of cancer, such as skin cancer or cancer of the cervix. Ask your doctor about this risk.

If you use infliximab while you are pregnant, make sure any doctor caring for your new baby knows that you used the medicine during pregnancy. Being exposed to infliximab in the womb could affect your baby's vaccination schedule during the first 6 months of life.

You should not breastfeed while you are receiving infliximab.

Infliximab is not for use in children younger than 6 years old.

Side Effects

What are the side effects of Infliximab (Intravenous)?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, difficult breathing; fever, chills, severe dizziness; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy or tingly, short of breath, or have a headache, fever, chills, muscle or joint pain, pain or tightness in your throat, chest pain, or trouble swallowing during the injection. Infusion reactions may also occur within 1 or 2 hours after injection.

Serious and sometimes fatal infections may occur during treatment with infliximab. Call your doctor right away if you have signs of infection such as: fever, extreme tiredness, flu symptoms, cough, or skin symptoms (pain, warmth, or redness).

Also call your doctor if you have:

skin changes, new growths on the skin;
pale skin, easy bruising or bleeding;
delayed allergic reaction (up to 12 days after receiving infliximab)--fever, sore throat, trouble swallowing, headache, joint or muscle pain, skin rash, or swelling in your face or hands;
liver problems--right-sided upper stomach pain, loss of appetite, yellowing of your skin or eyes, and not feeling well;
lupus-like syndrome--joint pain or swelling, chest discomfort, feeling short of breath, skin rash on your cheeks or arms (worsens in sunlight);
nerve problems--numbness or tingling, problems with vision, weakness in your arms or legs, seizure;
new or worsening psoriasis--skin redness or scaly patches, raised bumps filled with pus;
signs of heart failure--shortness of breath with swelling of your ankles or feet, rapid weight gain;
signs of a stroke--sudden numbness or weakness, trouble speaking or understanding what is said to you, problems with vision or balance, severe headache;
signs of lymphoma--fever, night sweats, weight loss, stomach pain or swelling, chest pain, cough, trouble breathing, swollen glands (in your neck, armpits, or groin); or
signs of tuberculosis--fever, cough, night sweats, loss of appetite, weight loss, feeling constantly tired.

Serious infections may be more likely in adults who are 65 years or older.

Common side effects may include:

stuffy nose, sinus pain;
fever, chills, sore throat;
cough, chest pain, shortness of breath;
high or low blood pressure;
headache, feeling light-headed;
rash, itching; or
stomach pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Dosage Guidelines & Tips

How to take Infliximab (Intravenous)?

Use Infliximab (Intravenous) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Before you start treatment with infliximab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Infliximab is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 2 hours to complete.

You may be watched closely after receiving infliximab, to make sure the medicine has not caused any serious side effects.

Infliximab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis, and you may need frequent TB tests.

Serious infections may be more likely in older adults.

If you need surgery, tell the surgeon ahead of time that you are using infliximab.

If you've ever had hepatitis B, using infliximab can cause this virus to become active or get worse. You may need frequent liver function tests while using this medicine and for several months after you stop.

What should I do if I missed a dose of Infliximab (Intravenous)?

Call your doctor for instructions if you miss an appointment for your infliximab injection.