Drug Notebook

FDA Alerts

  • Risk of potentially serious infection. Serious infections (some fatal), including tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections reported. (See Infectious Complications under Cautions.)
  • Prior to infliximab therapy, evaluate patients for latent tuberculosis infection with a tuberculin skin test and, if indicated, initiate an appropriate antimycobacterial regimen. Antimycobacterial treatment lowers the risk of latent tuberculosis infection progressing to active disease. Active tuberculosis has developed in infliximab-treated patients with a negative tuberculin skin test. Continue to monitor all patients, including those with a negative tuberculin skin test, for active tuberculosis.

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infliximab
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(in FLIX ih mab)

What is the most important information I should know about infliximab?

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

Treatment with infliximab may increase your risk of developing certain types of cancer or autoimmune disorders (such as a lupus-like syndrome). Talk with your doctor about your individual risk.

Infliximab can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor.

Serious and sometimes fatal infections may occur during treatment with infliximab. Contact your doctor right away if you have signs of infection such as: fever, chills, sore throat, flu symptoms, easy bruising or bleeding, pale skin, or unusual weakness.

Do not receive a "live" vaccine while you are being treated with infliximab.

What is infliximab?

Infliximab reduces the effects of a substance in the body that can cause inflammation.

Infliximab is used to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis (Crohn's disease), and ankylosing spondylitis. Infliximab is also used to treat severe or disabling plaque psoriasis (raised, silvery flaking of the skin).

Infliximab is often used when other medicines have not been effective.

Infliximab may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using infliximab?

You should not use this medication if you have heart failure, or if you are also being treated with anakinra (Kineret).

Before using infliximab, tell your doctor if you are allergic to any drugs, or if you have:

If you have any of these conditions, you may not be able to use infliximab, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether infliximab passes into breast milk. Do not use infliximab without first talking to your doctor if you are breast-feeding a baby. Infliximab is not for use in children younger than 6 years old.

Using this medication may increase your risk of certain types of cancer, such as breast, colon, or skin cancer. Talk with your doctor about your specific risk.

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