What You Need to Know About Remicade (Infliximab)

Remicade (infliximab) is a type of drug known as a monoclonal antibody. TNF-alpha (tumor necrosis factor alpha) is found in higher amounts in people with Crohn's disease than it is in people who do not have any form of inflammatory bowel disease (IBD). Remicade stops TNF-alpha from being used by the body.

TNF-alpha is actually a cytokine, which plays a role in the inflammatory process in the body. IBD is an inflammatory condition, and TNF-alpha is believed to play a role in the way IBD affects the gastrointestinal system. A cytokine goes between cells in the body delivering chemical "messages."

Remicade is given as an infusion through an IV line, often in a hospital or doctor's office setting. The infusion is given slowly over several (usually two or more) hours. The physician who prescribes Remicade will provide any special instructions that patients should follow before the infusion appointment.

Remicade may be prescribed for both of the main forms of IBD: moderate to severe ulcerative colitis or Crohn's disease. Remicade is also approved for use in children over the age of 6 who have moderate to severe Crohn's disease or moderate to severe ulcerative colitis that is not responding to other drug therapies. It may also be given for people with Crohn's disease who have fistulas and to treat certain forms of rheumatoid arthritis.

Remicade bonds to TNF-alpha, preventing it from causing inflammation in the body. With the TNF-alpha unable to cause inflammation, a person with IBD may experience an inactive time in the disease process, also called remission.

Tell your doctor if you have ever had any of the following conditions:

• Allergic reactions to any medication
• Current pregnancy
• Cancer
• Infections
• Lupus
• Recent vaccination

Common side effects of Remicade include abdominal pain, nausea, fatigue, and vomiting. Tell your doctor if any side effects are bothersome or don't go away.

Rarely other, more serious side effects can occur, such as difficulty urinating, infection, irregular heartbeat, and rectal pain. These side effects should be reported to your physician immediately.

Remicade has not been extensively studied for drug interactions. During clinical trials of Remicade, some patients were already taking antibiotics, antivirals, corticosteroids (such as prednisone), 6-MP/AZA and aminosalicylates. These patients did not experience a greater amount of infusion reactions than those who were not taking any other drugs.

However, people receiving Remicade should not receive any vaccines containing live viruses or bacteria (the seasonal influenza shot does not contain a live virus). Remicade suppresses the immune system, and taking other drugs that suppress the immune system at the same time could increase the possible risk of infection. A physician should be consulted about any other medications being taken at the same time as Remicade.

There are no known food interactions.

The FDA has classified Remicade as a type B drug. The effect that Remicade has on an unborn child has not been studied extensively. Remicade should only be used during pregnancy if clearly needed. Notify the prescribing doctor if you become pregnant while taking Remicade. It is thought that Remicade does not pass into breast milk. Women should check with their physicians, but it is currently thought that women who are receiving Remicade should not be discouraged from breastfeeding their infants, particularly given the widespread benefits of breast milk for an infant.

Janssen Pharmaceuticals has a Patient Assistance Program to help in getting medical coverage for Remicade. Help may also be available from local IBD organizations.