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No adequate and well-controlled studies of the combined or sequential use of FEIBA NF 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 or aminocaproic 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 a potential drug interaction cannot be excluded according to available in vitro data and clinical observations (potentially resulting in adverse events such as a thromboembolic event).
Clinical experience from an emicizumab clinical trial suggests that a potential drug interaction may exist with emicizumab when FEIBA was used as part of a treatment regimen for breakthrough bleeding which may result in thromboembolic events and/or thrombotic microangiopathy (see Warnings and Precautions).
