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lepirudin (Discontinued)Brand and Other Names:Refludan

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 50mg/vial
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Heparin-induced Thrombocytopenia

Discontinued by manufacturer (5/17/2012)

0.4 mg/kg (not to exceed 44 mg) IV over 15-20 sec initially, THEN

0.15 mg/kg/hr (not to exceed 16.5 mg/hr) IV for 2-10 day  

Dose Adjustment

Maintain aPTT ratio 1.5-2.5; monitor 4 hr after initial dose, then qDay

If aPTT high: Stop infusion for 2 hr, then restart infusion at 50% dose (no bolus)

If aPTT low: Increase dose in steps of 20%

Renal Impairment

Initial 0.2 mg/kg (not to exceed 22 mg) IV over 15-20 sec, THEN

CrCl 45-60 mL/min: 0.075 mg/kg/hr

CrCl 30-44 mL/min: 0.045 mg/kg/hr

CrCl 15-29 mL/min: 0.0225 mg/kg/hr

CrCl <15 mL/min: Contraindicated

Safety and efficacy not established

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Interactions

Interaction Checker

lepirudin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Injection site bleeding (14%)

            Anemia (12%)

            Hematoma (11%)

            Bleeding (<11%)

            Extrinsic allergic respiratory disease (10% or more)

            1-10%

            Hematuria (7%)

            Liver function test abnormalities (5%)

            Pericardial effusion (1%)

            Pneumonia (5%)

            Ventricular fibrillation (1%)

            Epistaxis (4%)

            Fever (4%)

            Heart failure (4%)

            Gastrointestinal hemorrhage (4%)

            Rectal hemorrhage (4%)

            Cutaneous hypersensitivity (4%)

            Increased transaminases (6%)

            Hematuria (4%)

            Sepsis (4%)

            Renal failure (2%)

            <1%

            Cerebral ischemia

            Confusion

            Peripheral nerve facial nerve paralysis

            Intracranial hemorrhage (rare)

            Anaphylaxis (rare)

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            Warnings

            Contraindications

            Hypersensitivity to hirudins

            Severe renal insufficiency (CrCl <15 mL/min)

            Cautions

            Formation of antihirudin antibodies (40%) may increase anticoagulant effect; monitor aPTT carefully

            Cirrhosis may enhance anticoagulant effect

            Patients with increased risk of bleeding

            Cautiously administer after a thrombolytic episode (risk of intracranial bleeding)

            Allergic reactions frequently reported in patients treated concomitantly with streptokinase

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            Pregnancy & Lactation

            Pregnancy Category: B

            Lactation: Not known if excreted in breast milk, not recommended

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Recombinant hirudin (leech anticoagulant), specific thrombin inhibitor; increases aPTT

            Pharmacokinetics

            Half-life: 1.3 hr

            Distribution: Confined to extracellular fluids

            Clearance: 164 mL/min

            Excretion: Urine (48%)

            Dialyzable: Yes

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            Administration

            IV Incompatibilities

            Do not mix with any other drug

            IV Preparation

            Reconstitute 50 mg vials with 1 mL SWI or NS, swirl gently to mix, should not take more than a few seconds

            Bolus injection

            • Transfer reconstituted vial contents (1 mL) into single-use syringe with at least 10 mL capacity
            • Dilute with SWI, NS or D5W to total volume of 10 mL for a final concentration of 5 mg/mL

            Infusion (makes 0.4 mg/mL or 0.2 mg/mL)

            • Transfer 2 reconstituted vial contents to 250 mL or 500 mL of NS or D5W

            IV Administration

            Bolus: over 15-20 sec

            See adult dosing for infusion rate

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