Idarucizumab

Limited reviewed summaryFull monograph review pending

No original GlobalRPh dilution article is available for this record.

Reviewed product information

Applies to

Praxbind idarucizumab 2.5 g/50 mL single-dose vial, adult IV administration.

Check the product label for line flushing and access requirements. This summary covers the ready-to-use infusion presentation.

Preparation sources checked 2026-11-13.

Ready To Use

The 2.5 g/50 mL vial contains a ready-to-infuse solution. No reconstitution or further dilution is needed.

Sources and exact locations

Claim ID: IVR-70-IDARUCIZUMAB-001

Review basis: Separately authored institutional guidance

Source 1
Praxbind U.S. prescribing information (opens in a new tab)
Exact location: 2.2 Preparation (SPL section a5a286ce-a5d0-4e6f-9f84-6c66bd2c5f88); 2.3 Administration (SPL section 4be9e502-a02a-437e-a3a2-4b244594ef75); 3 DOSAGE FORMS AND STRENGTHS (SPL section e9f4b6c9-dba2-4457-989e-78c464af1b58)
Publisher: DailyMed / Boehringer Ingelheim Pharmaceuticals, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:26:24.386587+00:00
Source 2
Galway adult IV guide: Idarucizumab (opens in a new tab)
Exact location: Available preparations, Reconstitution and Infusion fluids
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:26:24.853730+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Administration

When the prescribed 5 g dose is given by infusion, administer the two 2.5 g vials consecutively.

Sources and exact locations

Claim ID: IVR-70-IDARUCIZUMAB-002

Review basis: Separately authored institutional guidance

Source 1
Praxbind U.S. prescribing information (opens in a new tab)
Exact location: 2.3 Administration (SPL section 4be9e502-a02a-437e-a3a2-4b244594ef75)
Publisher: DailyMed / Boehringer Ingelheim Pharmaceuticals, Inc.
Source family: U.S. product prescribing information
Retrieved: 2026-11-13T14:26:24.386587+00:00
Source 2
Galway adult IV guide: Idarucizumab (opens in a new tab)
Exact location: Methods of intravenous administration, Intermittent intravenous infusion
Publisher: Galway University Hospitals Medicines Information
Source family: Galway University Hospitals Medicines Information
Retrieved: 2026-11-13T14:26:24.853730+00:00
Separately edited hospital guidance may draw on product labeling. Only overlapping preparation steps are used.

Product identifiers and clinical review status

Selected prescribing information available. Full monograph review pending.

Selected product identity

Matched to U.S. product NDC 0597-0197 for the preparation statements shown.

View product identifiers and primary-label provenance

Selected product scope: Praxbind idarucizumab 2.5 g/50 mL single-dose vial, adult IV administration.
Field ID: IVR-70-IDARUCIZUMAB-META-PRODUCT_SCOPE
Primary source (opens in a new tab) | Product data elements and the claim-specific formulation described in the cited preparation sections
Complete product reconciliation: pending.
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Field ID: IVR-70-IDARUCIZUMAB-META-LABELER
Primary source (opens in a new tab) | SPL author/assignedEntity/representedOrganization/name
Complete product reconciliation: pending.
Application number(s): BLA761025
Field ID: IVR-70-IDARUCIZUMAB-META-APPLICATION_NUMBERS
Primary source (opens in a new tab) | SPL subjectOf/approval/id/@extension
Complete product reconciliation: pending.
NDC(s): 0597-0197-05
Field ID: IVR-70-IDARUCIZUMAB-META-NDCS
Primary source (opens in a new tab) | SPL manufacturedProduct/asContent/containerPackagedProduct/code/@code and How Supplied
Complete product reconciliation: pending.
DailyMed Set ID: c7400f8a-dcf4-a6df-6d07-983081b1bf34
Field ID: IVR-70-IDARUCIZUMAB-META-SETID
Primary source (opens in a new tab) | SPL document/setId/@root
Complete product reconciliation: pending.
SPL version: 8
Field ID: IVR-70-IDARUCIZUMAB-META-SPL_VERSION
Primary source (opens in a new tab) | SPL document/versionNumber/@value
Complete product reconciliation: pending.
Label printed revision date: Not established
SPL effective date: 2024-01-23
Field ID: IVR-70-IDARUCIZUMAB-META-REVISION_DATE
Primary source (opens in a new tab) | SPL document/effectiveTime/@value
Complete product reconciliation: pending.
Retrieved: 2026-11-13T14:26:24.386587+00:00
Field ID: IVR-70-IDARUCIZUMAB-META-RETRIEVED_AT
Primary source (opens in a new tab) | Timestamp recorded when source bytes were retrieved
Complete product reconciliation: pending.
Downloaded XML SHA-256: f720a63529ca48a39bc3749f4b3d7c2aa0637a62926d2104f8721e6c62b68573
Field ID: IVR-70-IDARUCIZUMAB-META-XML_SHA256
Primary source (opens in a new tab) | SHA-256 computed over the exact downloaded XML bytes
Complete product reconciliation: pending.

What remains to be completed

Extract and verify presentation-specific IV preparation.
Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.

All medications Return to medication heading Application top