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No adequate and well-controlled studies of the combined or sequential use of FEIBA and recombinant Factor VIIa, antifibrinolytics, or emicizumab have been conducted.
The possibility of thromboembolic events should be considered when systemic antifibrinolytics such as tranexamic acid and aminocarpoic acid are used during treatment with FEIBA. Therefore, antifibrinolytics should not be used for approximately 6 to 12 hours after the administration of FEIBA.
In cases of concomitant rFVIIa use, according to available in vitro data and clinical observations a potential drug interaction may occur (potentially resulting in adverse events such as a thromboembolic event).
Benefit-risk evaluation of FEIBA to be administered to emicizumab-exposed patients is required, and patients must be closely monitored by their physicians.
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