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Label Changes for:

Enbrel (etanercept)

November 2009

Changes have been made to the BOXED WARNING, WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009

BOXED WARNING

Malignancy
  • Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including Enbrel.

WARNINGS

Malignancies
  • Cases of acute and chronic leukemia have been reported in association 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 higher risk (approximately 2-fold) than the general population for the development of leukemia.
  • During the controlled portions of Enbrel trials, 2 cases of leukemia were observed among 5445 (0.06 cases per 100 patient years) Enbrel-treated patients versus 0 among 2890 (0%) control patients (duration of controlled treatment ranged from 3 to 48 months).
  • Among 15,401 patients treated with Enbrel in controlled and open portions...
Pediatric Patients
  • Malignancies, some fatal, have been reported among children, adolescentreceived treatment with TNF-blocking agents (initiation of therapy at < 18 years Enbrel. Approximately half the cases were lymphomas, including Hodgkin’s and non-Hodgkin’s lymphoma...
  • In clinical trials of 696 patients, representing 1282 patient-years of therapy, noincluding lymphoma or NMSC, have been reported...

MEDICATION GUIDE

  • Updated risk of malignancies in pediatric patients, leukemia in adults, and psoriasis-like lesions associated with use of products within the class of TNF-blockers
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