Remicade Information
Remicade (infliximab) is a monoclonal antibody that specifically targets
and binds to TNF-a (tumor necrosis factor alpha) on the cell membrane
and in the blood. TNF is a small protein which has a significant role
in the regulation of the immune system. Overproduction of TNF-a is believed
to be a cause of rheumatoid arthritis and Crohn's Disease. By blocking
the action of TNF-alpha, Remicade reduces the inflammation and its accompanying
signs and symptoms.
Remicade is a type of protein that recognizes, attaches to, and blocks
the action of a substance in your body called tumor necrosis factor. Tumornecrosis
factor (TNF) is made by certain blood cells in your body. Remicade will
not cure rheumatoid arthritis or Crohn's disease, but blocking TNF with
Remicade may reduce the inflammation caused by too much TNF in your body.
Remicade can either be used alone or is often combined with methotrexate
for treating rheumatoid arthritis in patients who have not adequately
responded to methotrexate alone. In these patients, the drug is used to
prevent joint damage that is caused by the rheumatoid arthritis
Manufactured by the Johnson & Johnson subsidiary, Centocor, Remicade
(also known by its generic name, infliximab) is approved for treating
rheumatoid arthritis and Crohn's disease (an inflammatory bowel condition).
Remicade has been on the market since 1998. It is being studied for the
treatment of psoriasis and psoriatic arthritis, and some doctors are already
prescribing it for these diseases.
There have been rare reports of central nervous system disorders in
association with the use of Remicade. Doctors are advised to use caution
in considering the use of Remicade in patients with pre-existing or the
recent onset of central nervous system disorders, including multiple sclerosis.
About 10 percent of patients develop antibodies to the medication, and
these patients are more likely to have an allergic-type reaction to the
infusion.
It has been shown that Remicade may worsen existing
heart failure. On October 18, 2001, Centocor issued a "Dear Doctor" letter,
which warns practicing health care providers not to give Remicade to persons
with congestive heart failure. In a six week aborted Remicade trial, conducted
by the Remicade manufacturer Centocor, heart patients taking the drugs
worsened as compared to those who were not on the medication. Seven out
of 101 heart patients treated with Remicade died. None of the 49 patients
taking a placebo died during trial. The failed experiment pointed up a
potentially deadly situation involving patients with congestive heart
failure (CHF) who are taking the drug for their arthritis. Because of
this risk, the FDA issued a warning about the drug and the drug manufacturer
sent letters to thousands of doctors alerting them to the risk.
Tuberculosis, invasive fungal infections and other serious infections
have been reported in Remicade patients; some of the
infections have been fatal. The infections often occurred in patients
who were also using other medications that suppress the immune system,
like methotrexate. There is even a black box warning on Remicade's label
about the risk of Tuberculosis and Histoplasmosis.
The FDA has reviewed the association between TNF-alpha medications like
Remicade and an increased risk of developing lymphoma,
a type of cancer. The FDA concluded there is not enough data to know if
these medications contributed to higher risk. Remicade's safety and side
effectscontinue to be monitored by Centocor and the FDA.
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