idarucizumab

REMS

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

Contraind./Precautions ⬆ ⬇

Contraindicated in:

None reported.

Use Cautiously in:

OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children;
Geri: Older adults may be more sensitive to drug effects.

Exercise Extreme Caution in:

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

Adv. Reactions/Side Effects ⬆ ⬇

CV: THROMBOEMBOLISM

F and E: hypokalemia

GI: constipation

Neuro: delirium

Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

None reported.

Availability ⬆ ⬇

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

Route/Dosage ⬆ ⬇

IV (Adults ): 5 g as single dose.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Human monoclonal antibody fragment 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 effects:

Reversal of the anticoagulant effect of dabigatran.

Classifications ⬆ ⬇

Therapeutic Classification: antidotes

Pharmacologic Classification: monoclonal antibodies

Pharmacokinetics ⬆ ⬇

Absorption: IV administration results in complete bioavailability.

Distribution: Minimally distributed to tissues.

Metabolism/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 ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
IV	immediate	unknown	24 hr

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.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Indications ⬇