Label Changes for:

Simponi (golimumab)

November 2012

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

November 2012

ADVERSE REACTIONS

Postmarketing Experience
  • sarcoidosis

DRUG INTERACTIONS

  • Biologic Products for RA, PsA, and/or AS
  • The concomitant use of SIMPONI with biologics approved to treat RA, PsA, or AS is not recommended because of the possibility of an increased risk of infection. 

 

 

November 2009 

 

BOXED WARNING

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

WARNINGS and PRECAUTIONS

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 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 to 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.

MEDICATION GUIDE

Cancer
  • There have been cases of unusual cancers in children and teenage patients taking TNF-blocking agents.
  • For children and adults taking TNF-blocker medicines, including Simponi, the chances of getting lymphoma or other cancers may increase.
  • People with inflammatory diseases including rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, especially those with very active disease, may be more likely to get lymphoma.

 

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