Generic Name

Idarucizumab

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Classification

FDA Approved Indications

• Reversal of dabigatran anticoagulant effect in adult patients when rapid reversal is required due to emergent bleeding or urgent procedures.

Mechanism of Action

Idarucizumab binds specifically to dabigatran molecules, neutralizing their anticoagulant effect by forming complexes that are cleared from the circulation, thus rapidly reversing dabigatran-induced anticoagulation.

Dosage and Administration

Adult: 5 g IV administered as two separate 2.5 g doses no more than 15 minutes apart.

Pediatric: Not approved for pediatric use; limited data.

Geriatric: Dose remains the same; monitor renal function as needed.

Renal Impairment: Adjustments not specified; use with caution in renal impairment.

Hepatic Impairment: No specific adjustments documented.

Pharmacokinetics

Absorption: Not applicable (administered IV).

Distribution: Widely distributed; 34% protein bound.

Metabolism: Metabolized via endocytosis and catabolism; specific pathways not well defined.

Excretion: Primarily renal excretion of complexes and metabolites.

Half Life: Approximately 45 minutes.

Contraindications

• Known hypersensitivity to idarucizumab or any component of the formulation.

Precautions

• Use with caution in patients with hypersensitivity reactions. Not recommended for use in patients on anticoagulants other than dabigatran.

Adverse Reactions - Common

• Fever (Uncommon)
• Headache (Uncommon)

Adverse Reactions - Serious

• Anaphylaxis (Rare)
• Thromboembolic events (Rare)

Drug-Drug Interactions

• None known to interfere with its action; avoid use with other reversal agents unless specifically indicated.

Drug-Food Interactions

• No interactions documented.

Drug-Herb Interactions

• No interactions documented

Nursing Implications

Patient/Family Teaching

• Inform about the purpose of the medication.
• Report any allergic reactions immediately.
• Educate on the importance of medical supervision during and after administration.

Special Considerations

Black Box Warnings:

• Risk of thrombosis after reversal of dabigatran; patients should be monitored closely.
• Use only for dabigatran reversal as indicated.

Genetic Factors: None identified.

Lab Test Interference: May falsely lower coagulation parameters such as dTT and ECT; interpret with caution.

Overdose Management

Signs/Symptoms: Possible thrombosis, allergic reactions.

Treatment: Supportive care; no specific antidote for overdose, manage symptoms accordingly.

Storage and Handling

Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F).

Stability: Stable for at least 24 months when stored properly.