Idarucizumab: uses, dosing, side effects & brands

How idarucizumab is dosed

From the FDA label for Praxbind (application BLA761025). Other idarucizumab products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.

For intravenous use only. The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab. ( 2.1 ) There is limited data to support administration of an additional 5 g of PRAXBIND. ( 2.1 ) 2.1 Recommended Dose The recommended dose of PRAXBIND is 5 g, provided as two separate vials each containing 2.5 g/50 mL idarucizumab (see Figure 1 ). Both vials are packaged together in one carton. For intravenous use only. There is limited data to support administration of an additional 5 g of PRAXBIND [see Warnings and Precautions (5.2) ]. 2.2 Preparation Remove both vials (each containing 2.5 g/50 mL idarucizumab) from carton. Ensure aseptic handling when preparing the infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Once solution has been removed from the vial, administration should begin promptly. The solution in vials may be stored at room temperature, 25°C (77°F), but must be used within 6 hours [see How Supplied/Storage and Handling (16.2) ] . 2.3 Administration Do not mix with other medicinal products. Use aseptic technique when administering PRAXBIND. Intravenously administer the dose of 5 g (2 vials, each contains 2.5 g) as Two consecutive infusions (see Figure 2 ) or Bolus injection by injecting both vials…

Idarucizumab side effects

Who shouldn’t take idarucizumab

Idarucizumab and breastfeeding

From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.

No information is available on the clinical use of idarucizumab during breastfeeding. Because it is a large protein molecule with a molecular weight of about 48,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, idarucizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

National Institute of Child Health and Human Development, record revised November 15, 2023. LactMed states its information is not a substitute for professional judgement.

What people report to the FDA about idarucizumab

The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 143 reports naming idarucizumab, and the FDA flagged 98% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:

• haemorrhage28 reports
• acute kidney injury9 reports
• haematoma9 reports
• anaemia8 reports
• gastrointestinal haemorrhage8 reports
• shock haemorrhagic8 reports
• rebound effect7 reports
• sepsis7 reports

Source: openFDA drug/event (FAERS), retrieved July 25, 2026.

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