20:28.92 Antihemorrhagic Agents, Miscellaneous
Generic Name
Idarucizumab is available as a preservative-free solution in single-use vials in packs containing 2 vials.3094 Each 50-mL vial contains idarucizumab 2.5 g, glacial acetic acid 10.05 mg, polysorbate 20 10 mg, sodium acetate trihydrate 147.35 mg, sorbitol 2004.2 mg, and water for injection.3094
Idarucizumab should be visually inspected for particulate matter or discoloration prior to administration.3094
pH
From 5.3 to 5.7.3094
Osmolality
Idarucizumab is isotonic with an osmolality of 270 to 330 mOsm/kg.3094
Trade Name(s)
Praxbind
Idarucizumab should be administered intravenously by infusion or by bolus injection.3094 For intravenous infusion, each 2.5-g vial should be infused consecutively to total 5 g.3094 The drug also has been administered as a single infusion of 5 g over 5 minutes in some clinical studies.3094
For intravenous bolus injection, a syringe should be used to withdraw and consecutively inject the contents of 2 vials.3094
If an existing intravenous line is used for idarucizumab administration, the line must be flushed with sodium chloride 0.9% prior to administration.3094
Intact vials should be stored at 2 to 8°C.3094 Idarucizumab is a colorless to slightly yellow, clear to slightly opalescent solution.3094 Vials should not be frozen or shaken.3094
Unopened vials of idarucizumab may be stored at 25°C for up to 48 hours when stored in the original package to protect from light or for up to 6 hours when exposed to light.3094
Administration of idarucizumab should begin promptly (within 1 hour) once the solution has been withdrawn from the vial.3094
For a list of references cited in the text of this monograph, search the monograph titled References.