Generic Name

Bivalirudin

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Classification

FDA Approved Indications

• Prevention of blood clot formation in patients undergoing percutaneous coronary intervention (PCI)

Mechanism of Action

Bivalirudin is a directly reversible, specific, and reversible thrombin inhibitor. It binds directly to thrombin, inhibiting its activity, which prevents conversion of fibrinogen to fibrin, thereby reducing clot formation.

Dosage and Administration

Adult: Typically, a bolus dose of 0.75 mg/kg IV administered immediately before PCI, followed by an infusion of 1.75 mg/kg/hr during the procedure.

Pediatric: Not approved for pediatric use.

Geriatric: Adjusted based on renal function and clinical judgment.

Renal Impairment: Dose adjustments are recommended for patients with renal impairment, especially those with CrCl <30 mL/min.

Hepatic Impairment: Use with caution; no specific dose adjustment established.

Pharmacokinetics

Absorption: Not applicable (administered intravenously).

Distribution: Vd approximately 0.2–0.3 L/kg.

Metabolism: Metabolized by proteolytic cleavage, primarily via nonspecific plasma proteases.

Excretion: Primarily excreted unchanged by the kidneys.

Half Life: About 25 minutes in patients with normal renal function.

Contraindications

• Active bleeding

Precautions

• Renal impairment, increased bleeding risk, allergic reactions. Use cautiously in patients with recent surgery or trauma.

Adverse Reactions - Common

• Bleeding (Common)
• Back pain (Less common)

Adverse Reactions - Serious

• Major bleeding (Less common)
• Hypotension (Less common)
• Anemia (Less common)

Drug-Drug Interactions

• Other anticoagulants, antiplatelet agents, thrombolytics

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Patient/Family Teaching

• Report unusual bleeding or bruising immediately.
• Inform about the importance of sticking to the scheduled doses and follow-up testing.
• Avoid activities that increase bleeding risk.

Special Considerations

Black Box Warnings:

• Significant risk of bleeding

Genetic Factors: None specified.

Lab Test Interference: May affect coagulation assays such as activated partial thromboplastin time (aPTT).

Overdose Management

Signs/Symptoms: Excessive bleeding, hypotension.

Treatment: Discontinue bivalirudin; supportive care, apply pressure to bleeding sites, and consider administration of protamine sulfate; hemodialysis has limited effect due to high protein binding.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C.

Stability: Stable until expiration date provided by manufacturer.