infliximab, Remicade (cont.)

Pharmacy Author:
Medical and Pharmacy Editor:

PREGNANCY: Use of infliximab in pregnant women has not been adequately evaluated.

NURSING MOTHERS: It is not known if infliximab is secreted in breast milk, and, therefore, if there are effects on the nursing infant.

SIDE EFFECTS: The most common side effects of infliximab are upper respiratory tract infections, urinary tract infections, cough, rash, back pain, nausea, vomiting, abdominal pain, headache, weakness and fever. Side effects such as low or high blood pressure, chest pain, difficulty breathing, rash, itching, fever and chills may occur during or shortly after administration. These reactions could indicate an allergy to the drug. They are more common among patients who develop antibodies to infliximab and are less likely to occur in patients who are taking drugs that suppress the immune system, such as methotrexate.

Infliximab should be discontinued if serious reactions occur. Serious infections have been reported with other drugs that block TNF- alpha, and infections have been reported during treatment with infliximab. Therefore, infliximab should not be used in patients with serious infections. Moreover, infliximab should be discontinued if a serious infection develops during treatment. Testing for tuberculosis (PPD tests for TB) should be doneprior to treatment with infliximab because of reports of reactivation of tuberculosis in patients taking infliximab. Such patients should be treated for tuberculosis.

Decreased white and red blood cell and decreased platelet counts have been reported with infliximab. Vasculitis (inflammation of the arteries) also has been reported.

Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of malignant lymphoma. More malignancies have been observed in open-label, uncontrolled clinical studies at a rate several-fold higher than expected in the general population. In controlled studies of TNF-alpha blocking agents, including infliximab, more cases of lymphoma and other malignancies have been observed among patients receiving the agents than among control group patients.

Reference: FDA Prescribing Information


Last Editorial Review: 2/2/2012



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