idaruCIZUmab (eye-da-roo-siz-ue-mab ) Praxbind

 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 Effects: 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

Contraindications/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: delerium. CV: THROMBOEMBOLISM. GI: constipation.

F and E: hypokalemia. Misc: hypersensitivity

reactions, fever.

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 single-use vial.