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Idarucizumab

Class
Anticoagulation reversal agents
Subclass
Anti-dabigatran monoclonal antibodies
Generic name
idaruCIZUmab
Brand names
Praxbind®
Common formulations
Solution for injection
Indications for use
Labeled indications
Adults
•
Treatment of bleeding tendency in patients with life-threatening conditions (uncontrolled bleeding)
•
Preparation for reversal of the anticoagulant effects of dabigatran
Safety risks
Contraindications
A known hypersensitivity to idarucizumab
Warnings and precautions
Exacerbation of hereditary fructose intolerance
•
Use caution with pre-existing fructose intolerance and signs and symptoms for hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, and ALF with the breakdown of excretory and synthetic function.
Thromboembolism
•
Use caution with risk factors for Thromboembolic disease.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
•
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B2
•
Use only if benefits outweigh potential risks. It is unknown if idarucizumab can cause fetal harm when administered during pregnancy or if it can affect reproductive ability.
•
There are no adequate or well-controlled studies in pregnant women, and animal reproductive and developmental studies have not been conducted with idarucizumab.
Breastfeeding
Acceptable for use during breastfeeding.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Common 1-10%
•
↓ serum potassium, delirium, constipation, fever, headache, thrombosis
Unknown frequency
•
Bronchospasm, hyperventilation, itching, skin rash
Interactions
Drug(s)
Check Interactions
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