idaruCIZUmab

General

Pronunciation:
eye-da-roo-siz-ue-mab

Trade Name(s)

Praxbind

Ther. Class.
antidotes

Pharm. Class.
monoclonal antibodies

Indications

To counteract the anticoagulant effect of dabigatran for emergency surgery/urgent procedures or life-threatening uncontrolled bleeding.

Action

Human monoclonal antibody fragment (Fab) that selectively binds to dabigatran and its metabolites, preventing its binding to thrombin and negating its anticoagulant effects.
Does not reverse any other anticoagulants.

Therapeutic Effect(s):

Reversal of the anticoagulant effect of dabigatran.

Pharmacokinetics

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism and Excretion: Biodegraded to smaller molecules. 60% excreted in urine, remainder via protein catabolism primarily in the kidneys.

Half-life: 10.3 hr.

TIME/ACTION PROFILE

ROUTE	ONSET	PEAK	DURATION
IV	immediate	unknown	24 hr

Contraindication/Precautions

Contraindicated in:

None noted.

Use Cautiously in:

Geri: Elderly patients may be more sensitive to drug effects;
OB: Safety not established. Consider maternal benefits and fetal risks;
Lactation: Safety not established, consider beneficial effects of breast feeding and possible adverse effects in infant;
Pedi: Safety and effectiveness not established.

Exercise Extreme Caution in:

Hereditary fructose intolerance (risk of serious adverse reactions due to sorbitol excipient);
History of serious hypersensivity (including anaphylactoid reactions) to idarucizumab.

Adverse Reactions/Side Effects

CNS: delirium

CV: THROMBOEMBOLISM

F and E: hypokalemia

GI: constipation

Misc: fever, hypersensitivity reactions

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

None noted.

Route/Dosage

IV (Adults) 5 g as single dose.

Availability

Solution for injection (contains sorbitol): 2.5 g/50 mL

Assessment

Reversal of dabigatran exposes patient to thrombotic risk of their underlying disease; may cause thromboembolism. Resume anticoagulant therapy as soon as medically appropriate. Dabigatran therapy can be reinstituted 24 hr after idarucizumab infusion.
Monitor for signs and symptoms of hypersensitivity reactions (rash, urticaria, fever, pruritus, dyspnea, orofacial swelling). Contains sorbitol; reactions in patients with hereditary fructose intolerance have included hypoglycemia, hypophosphatemia, metabolic acidosis, increase in uric acid, acute liver failure. If symptoms occur discontinue therapy and treat symptomatically.

Lab Test Considerations: Monitor coagulation parameters (activated partial thromboplastin time [aPTT], ecarin clotting time [ECT]) 12–24 hrs after infusion.

May cause hypokalemia.

Potential Diagnoses

Ineffective tissue perfusion (Adverse Reaction)

Implementation

Do not confuse idarucizumab with idarubicin.

IV Administration

Intermittent Infusion: Flush IV line with 0.9% NaCl prior to and following infusion. Solution is clear to opalescent, colorless to slightly yellow; do not administer solutions that are discolored or contain precipitates. Administer as 2 consecutive infusion or inject both vials consecutively via syringe. Must be administered within 1 hr when removed from vial. Store at room temperature and use within 6 hr if exposed to light.

Patient/Family Teaching

Explain purpose of idarucizumab to patient.
Instruct patient to notify health care professional immediately if bleeding or signs and symptoms of hypersensitivity occur.
Advise patient to notify health care professional if pregnancy is planned or suspected, or if breast feeding.

Evaluation/Desired Outcomes