GENERIC NAME: infliximab

BRAND NAME: Remicade

DRUG CLASS AND MECHANISM: Infliximab is an antibody that blocks the effects of tumor necrosis factor alpha (TNF alpha). Infliximab is administered by intervenous infusion. There are two other injectable drugs that block TNF alpha--adalimumab(Humira) and etanercept (Enbrel). TNF is a substance made by cells of the body which has an important role in promoting inflammation. Specifically, infliximab is used for treating the inflammation of Crohn's disease, rheumatoid arthritis, psoriasis, ankylosing spondylitis, and psoriatic arthritis. By blocking the action of TNF-alpha, infliximab reduces the signs and symptoms of inflammation. Infliximab does not cure Crohn's disease, psoriatic arthritis or rheumatoid arthritis; however, preliminary studies have demonstrated that infliximab can retard the destruction of joints by rheumatoid arthritis.

GENERIC AVAILABLE: No

PRESCRIPTION: Yes

PREPARATIONS: Powder for intravenous injection, 100 mg

STORAGE: Refrigerate at 2-8°C (36-46°F)

PRESCRIBED FOR: Infliximab is approved for use alone or combined with methotrexate for treating moderate to severe rheumatoid arthritis.  Infliximab is used for reducing the signs and symptoms of inflammation in moderate to severe Crohn's disease and Crohn's disease in which there are fistulas (passageways created when the inflammation penetrates beyond the wall of the intestine). It also is approved for the treatment of active psoriatic arthritis.  Infliximab is helpful in reducing the joint inflammation of juvenile rheumatoid arthritis, ankylosing spondylitis, and psoriasis, psoriatic arthritis. It also has been found to be helpful in treating the inflammation of uveitis, psoriasis, and for sarcoidosis that is not responding to traditional therapies. Infliximab is approved for use in pediatric patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy.

DOSING: Infliximab is administered intravenously. For moderate to severe Crohn's disease the dose is 5 mg/kg administered as a single dose. For fistulizing Crohn's disease, the dose is 5 mg/kg followed by additional doses of 5 mg/kg two and six week after the first dose.

The recommended dose for the treatment of rheumatoid arthritis is 3 mg/kg as a single dose. The initial dose should be followed by additional 3 mg/kg doses two and six weeks after the first dose. Thereafter, the maintenance dose is 3 mg/kg every eight weeks.

DRUG INTERACTIONS: The interaction of infliximab with other drugs has not been studied.

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 is the potential for 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.

Before starting infliximab, persons are recommended to have tuberculosis skin testing (PPD tests for TB), because of reports of reactivation of tuberculosis in patients taking infliximab.

Decreased white and red blood cell and decreased platelet counts have been reported with infliximab. Vasculitis (inflammation of 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 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 TNFá-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