Drug Interactions between Autoplex T and emicizumab

MONITOR CLOSELY: Coadministration of emicizumab with activated prothrombin complex concentrate (aPCC) may increase the risk of thrombosis. Cases of thrombotic microangiopathy (TMA) and other thrombotic events have been reported when cumulative amounts greater than 100 U/kg/24 hours of aPCC was administered for 24 hours or more to patients receiving emicizumab prophylaxis. In two emicizumab efficacy trials, TMA was reported in 1.6% (3/189) and 8.3% of patients (3/36) who received at least one dose of aPCC. Evidence of improvement was seen within one week following discontinuation of aPCC. Thrombotic events were reported in 1.1% (2/189) and 5.6% of patients (2/36) who received at least one dose of aPCC. No thrombotic event required anticoagulation therapy, and evidence of improvement or resolution was seen within one month following discontinuation of aPCC.

MANAGEMENT: Close monitoring is recommended when activated prothrombin complex concentrate must be used during emicizumab prophylaxis. Immediately discontinue aPCC and suspend dosing of emicizumab if clinical symptoms, imaging, and/or laboratory findings consistent with TMA or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming emicizumab prophylaxis following complete resolution of TMA or thromboembolism on a case-by-case basis.