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Hematologic Events Rare reports of pancytopenia including aplastic anemia, some with a fatal outcome, have been reported in patients treated with ENBRELŪ. The causal relationship to ENBRELŪ therapy remains unclear. Although no high risk group has been identified, caution should be exercised in patients being treated with ENBRELŪ who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (e.g., persistent fever, bruising,bleeding, pallor) while on ENBRELŪ. Discontinuation of ENBRELŪ therapy should be consideredin patients with confirmed significant hematologic abnormalities. Two percent of patients treated concurrently with ENBRELŪ and anakinra developed neutropenia(ANC < 1 x 109/L). While neutropenic, one patient developed cellulitis which recovered with antibiotic therapy. Text Continues Below
Malignancies In the controlled portions of clinical trials of all the TNF-blocking agents, more cases of lymphoma have been observed among patients receiving the TNF blocker compared to control patients. During the controlled portions of ENBRELŪ trials, 3 lymphomas were observed among 4509 ENBRELŪ-treated patients versus 0 among 2040 control patients (duration of controlled treatment ranged from 3 to 24 months). In the controlled and open-label portions of clinical trials ofENBRELŪ, 9 lymphomas were observed in 5723 patients over approximately 11201 patient-years of therapy. This is 3-fold higher than that expected in the general population. While patients with rheumatoid arthritis or psoriasis, particularly those with highly active disease, may be at a higher risk (up to several fold) for the development of lymphoma, the potential role of TNF-blockingtherapy in the development of malignancies is not known (see ADVERSE REACTIONS: Malignancies).11, 12 Page: << Prev | 1 | 2 | 3 | Next >>
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