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Balfaxar (prothrombin complex concentrate (human)-lans)
prothrombin complex concentrate (human)
Black Box Warnings .
Arterial and Venous Thromboembolic Complications
pts on vitamin K antagonists (VKA) tx have underlying dz states that predispose them to thromboembolic events; weigh benefits of reversing VKA vs. thromboembolic event risk, esp. in pts w/ thromboembolic event hx; carefully consider resuming anticoagulation when thromboembolism risk outweighs acute bleeding risk; arterial and venous thromboembolic complications, incl. fatal, have been reported; monitor pts for thromboembolic event s/sx; may not be suitable in pts w/ thromboembolic event in the prior 3mo
Adult Dosing .
Dosage forms: INJ
Special Note
- [formulation clarification]
- Info: nonproprietary name = prothrombin complex concentrate (human)-lans
vitamin K antagonist reversal
- [INR 2-3.9]
- Dose: 25 units/kg/dose IV x1; Max: 2500 units; Info: for pts w/ acute major bleeding or in need of urgent surgery/invasive procedure; give w/ vitamin K
- [INR 4-6]
- Dose: 35 units/kg/dose IV x1; Max: 3500 units; Info: for pts w/ acute major bleeding or in need of urgent surgery/invasive procedure; give w/ vitamin K
- [INR >6]
- Dose: 50 units/kg/dose IV x1; Max: 5000 units; Info: for pts w/ acute major bleeding or in need of urgent surgery/invasive procedure; give w/ vitamin K
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.