November 1, 2001
IMPORTANT DRUG WARNING
Dear Healthcare Professional:
Centocor, Inc. would like to inform you of important new safety information
for REMICADE ® (infliximab). Upon review of preliminary results of its
ongoing phase 2 trial in
150 patients with moderate to severe (NYHA class III-IV) congestive heart
failure (CHF), higher incidences of mortality and hospitalization for
worsening heart failure were seen in patients treated with REMICADE,
especially those treated with the higher dose of 10 mg/kg. Seven of
101 patients treated with REMICADE died compared to no deaths among the 49
patients on placebo. In this trial, stable but symptomatic patients with
NYHA Class III-IV CHF were treated with 3 infusions of REMICADE 5 mg/kg,
REMICADE 10 mg/kg, or placebo over 6 weeks.
REMICADE is a biological therapeutic product indicated for the treatment of
rheumatoid arthritis and Crohn?s disease.
Centocor, in consultation with FDA, is alerting physicians to these
potential adverse effects of REMICADE in patients with CHF. At present,
there are insufficient data to determine optimal patient management.
However, based on these preliminary findings, and pending additional data,
physicians should consider the following precautionary measures. For
patients with rheumatoid arthritis or Crohn?s disease being considered for
therapy with REMICADE:
? Do not initiate therapy in patients with congestive heart failure.
Patients with CHF currently receiving chronic REMICADE treatment for
rheumatoid arthritis or Crohn?s disease should be reevaluated.
? Treatment should be discontinued in patients whose CHF is worsening.
? Treatment discontinuation should be considered in patients with stable
concomitant CHF, especially in those who have not had a significant clinical
response to REMICADE therapy.
If a decision is made to continue treatment, cardiac status should be
Audience: Oncologists, Pharmacists, and other healthcare professionals FDA
and Roche have added a BLACK BOX WARNING and strengthened the PRECAUTIONS
section in the label for Xeloda, indicated for the treatment of colorectal
and breast cancer. A clinically important XELODA-Warfarin drug interaction
was demonstrated in a clinical pharmacology trial. Postmarketing reports
have shown clinically significant increases in prothrombin time and INR in
patients who were stabilized on anticoagulants at the time XELODA was
introduced. Patients receiving concomitant capecitabine and oral coumarin-derivative
anticoagulant therapy should have their anticoagulant response (INR or
prothrombin time) monitored frequently in order to adjust the anticoagulant
dose accordingly. The Patient Package Insert was also revised to reflect
this new safety information. New information is highlighted in the labels
[Nov 01, 2001 Label - (Revised sections only) - 25 Kb PDF file]
[Nov 01, 2001 Label - (Full Revised Label) - 1.77 MB PDF file]
[Nov 01, 2001 Label - (Revised Patient Package Insert) - 35 Kb PDF file]
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Remicade (infliximab) - Clinical Alert: Congestive Heart Failure
Audience: Rheumatologists, Gastroenterologists and other healthcare
professionals Centocor, in consultation with FDA, is alerting physicians to
potential serious adverse effects of REMICADE in patients with CHF.
Preliminary results of an ongoing phase 2 trial in patients with moderate to
severe CHF demonstrated higher incidences of mortality and hospitalization
for worsening heart failure in patients treated with REMICADE, especially
those treated with the higher dose of 10 mg/kg. Based on these preliminary
findings, and pending additional data, precautionary measures were
recommended in a "Dear Healthcare Professional" letter.
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