Idarucizumab

What it is and how it works

Mechanism of Action Idarucizumab is a specific reversal agent for dabigatran. It is a humanized monoclonal antibody fragment (Fab) that binds to dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin, neutralizing their anticoagulant effect.

Indications

is indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding PRAXBIND is a humanized monoclonal antibody fragment (Fab) indicated in patients treated with Pradaxa ® when reversal of the anticoagulant effects of dabigatran is needed: For emergency surgery/urgent procedures In life-threatening or uncontrolled bleeding

Dosage and administration (summary)

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. There is limited data to support administration of an additional 5 g of PRAXBIND. 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 . Preparation Remove both vials (each containing 2.5 g/50 mL idarucizumab) from carton. Ensure aseptic handling when preparing the infusion.

Contraindications

None. None

Warnings and precautions

Thromboembolic Risk: Reversing dabigatran therapy exposes patients to the thrombotic risk of their underlying disease. Resume anticoagulant therapy as soon as medically appropriate. ( 2.4 , 5.1 ) Re-elevation of Coagulation Parameters: In patients with elevated coagulation parameters and reappearance of clinically relevant bleeding or requiring a second emergency surgery/urgent procedure, an additional 5 g dose of PRAXBIND may be considered. Hypersensitivity reactions: Discontinue administration and evaluate.

Pregnancy

Pregnancy Risk Summary There are no available data on PRAXBIND use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. Animal reproductive and development studies have not been conducted with idarucizumab.

Storage and supply

Storage and Handling Store PRAXBIND vials in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake. PRAXBIND vials may be stored at room temperature, 25°C (77°F), for up to 48 hours in the original carton to protect from light.

Source: Idarucizumab (Praxbind) — US FDA prescribing information, 2024-01-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.