Idarucizumab Application Scope

Reversal of anticoagulation caused by dabigatran (Pradaxa) in adults requiring emergency surgery, urgent procedures, or experiencing life-threatening or uncontrolled bleeding.

Idarucizumab Characteristics

Ingredients:
- Active: Idarucizumab (humanized monoclonal antibody fragment)
- Excipients: sodium acetate trihydrate, acetic acid, sorbitol, polysorbate 20, water for injection
Properties:High‑affinity Fab fragment that binds dabigatran and its acylglucuronide metabolite (~350× higher than thrombin), neutralizing anticoagulant activity rapidly. No intrinsic procoagulant or anticoagulant effect.
Packaging Specification:2 vials per carton; each vial contains 2.5 g/50 mL idarucizumab solution (total 5 g)
Storage:Store refrigerated at 2 °C–8 °C; do not freeze; protect from light; unopened vials may be kept at room temperature (≤48 h if in original packaging)
Expiry Date:Up to 30 months from manufacture date when stored at 2–8 °C
Executive Standard: Manufactured following EMA/FDA pharmaceutical standards; See official Praxbind EPAR and label for details
Approval Number:EU authorization: EU/1/15/1056/001
Date of Revision:Most recent label revisions effective by 2022–2023; consult local SmPC/label
Manufacturer:Boehringer Ingelheim International GmbH, Biberach, Germany (formulated and packaged by Boehringer‑Ingelheim)

Guidelines for the Use of Praxbind

Dosage and Administration:
- Recommended Dose: 5 g total (two consecutive vials of 2.5 g/50 mL) via intravenous infusion or bolus injection
- Administration: Two consecutive IV infusions over 5‑10 minutes each, or as bolus injections. Infusion sets must be vented to avoid air embolism.
- Missed Dose: Not applicable—used in single emergency doses; repeat dosing only if bleeding persists or further surgery is needed (under specialist decision)
Adverse Reactions:
- Common Adverse Reactions (≥5%):
  - Hypokalaemia (∼7%)
  - Delirium (∼7%)
  - Constipation (∼7%)
  - Pyrexia and pneumonia (~6%)
  - Headache (~5%)
- Serious Adverse Reactions:
  - Thromboembolic events (stroke, pulmonary embolism, DVT, MI) occurring rarely
Contraindications:
- No formal contraindications listed, but avoid use in patients with known hypersensitivity to idarucizumab or excipients
- Use with caution in patients with hereditary fructose intolerance due to sorbitol content
Precautions:
- - Monitor for hypersensitivity reactions; discontinue if they occur
  - Resume anticoagulant therapy as medically appropriate to reduce thrombotic risk after reversal
  - Renal and hepatic impairment: no dose adjustment required
  - Pregnancy/lactation: No clinical data; use only if benefit outweighs risk; inform provider if pregnant or breastfeeding

Idarucizumab Interactions

Highly specific for dabigatran; no clinically relevant drug-drug interactions identified
No interactions with coagulation factor concentrates (PCCs) or volume expanders. Considered unlikely to interact with other medicines.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.