2009-12-01
The American Society of
Hematology (ASH) is providing this information at the request of the Food and Drug Administration (FDA) and Centocor Ortho Biotech Inc. in conjunction with a Risk
Evaluation and Mitigation Strategy (REMS) for Stelara™ (ustekinumab). All
questions should be directed to Centocor Ortho Biotech Inc. at 1-800-457-6399.
Dear ASH
Members,
FDA and Centocor Ortho
Biotech Inc. are asking for your assistance in reporting new cancer cases in
patients who have taken Stelara™ (ustekinumab), a new human monoclonal antibody
indicated for the treatment of adults with moderate to severe plaque
psoriasis. Because Stelara targets interleukin-12 (IL-12) and
interleukin-23 (IL-23) and based on data from rodent models, there is a
theoretical concern that blockade of IL-12 and IL-23 may increase the risk for
malignancies.
FDA and Centocor Ortho Biotech Inc. ask that if you are consulted to see a
patient with cancer at any time after he or she has received Stelara therapy,
it is important that you report the case even if you do not think there is a
causal relationship.
You can report the case to either FDA or Centocor Ortho Biotech Inc.:
- MedWatch (FDA safety information and adverse event
reporting program) at 1-800-332-1088 or online at www.fda.gov/medwatch/report.htm
- Centocor Ortho Biotech Inc. at 1-800-457-6399
Reporting is designed to be
easy and maintain patient confidentiality. Your patient’s name or contact
information is not needed. HIPAA does not apply to this adverse event reporting. For further
information, please see the manufacturer’s notice to
oncologists, letter
to health-care professionals, and prescribing information.
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