December 09, 2009
On November 18, 2009, the FDA Approved Revised Labeling for SIMPONI™ (golimumab)
Centocor Ortho Biotech Inc., would like to inform you of important changes to the prescribing information concerning pediatric malignancy and leukemia for SIMPONI™ (golimumab). Accordingly, Centocor Ortho Biotech has updated the Boxed WARNINGS and WARNINGS AND PRECAUTIONS sections of the product labeling to include information about these risks as follows:
Boxed WARNINGS: MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI is a member [see Warning and Precautions (5.2)].
5.0 WARNINGS AND PRECAUTIONS (see Boxed WARNINGS)
5.2 Malignancies
Malignancies, some fatal, have been reported among children, adolescents, and young adults who received treatment with TNF-blocking agents (initiation of therapy ≤ 18 years of age), of which SIMPONI is a member. Approximately half of the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma. The other cases represented a variety of malignancies, including rare malignancies that are usually associated with immunosuppression, and malignancies that are not usually observed in children and adolescents. The malignancies occurred after a median of 30 months (range 1 - 84 months) after the first dose of TNF blocker therapy. Most of the patients were receiving concomitant immunosuppressants. These cases were reported post-marketing and are derived from a variety of sources, including registries and spontaneous postmarketing reports.
Cases of acute and chronic leukemia have been reported with postmarketing TNF-blocker use in rheumatoid arthritis and other indications. Even in the absence of TNF blocker therapy, patients with rheumatoid arthritis may be at a higher risk (approximately 2-fold) than the general population for the development of leukemia.
Related changes to the Medication Guide were also made. Please refer to the SIMPONI™ (golimumab) prescribing information and Medication Guide on MEDVERSATION®. Note that other content on MEDVERSATION® related to this change will be updated in the near future.