Generic Name and Formulations:
Lepirudin 50mg/vial; pwd for IV inj or infusion after reconstitution and dilution; contains mannitol.
Indications for REFLUDAN:
Heparin-induced thrombocytopenia (HIT) and associated thromboembolic disease.
Do not start treatment if baseline aPTT ratio ≥2.5 to avoid initial overdosing. ≤110kg: Initially 0.4mg/kg by slow IV bolus inj over 15–20 seconds, follow by 0.15mg/kg/hour as a continuous IV infusion for 2–10 days or longer if clinically needed. >110kg: max initial bolus dose 44mg; max initial infusion dose 16.5mg/hour. Adjust dose based on aPTT ratio; usual target range (1.5–2.5). Monitor 1st aPTT determination at 4 hours after start of infusion and at least once daily during therapy; more frequently with renal impairment or serious liver injury. Dose adjustments, renal impairment, concomitant thrombolytic therapy: see literature.
Recent puncture or anomaly of vessels or organs. Recent cerebrovascular accident, stroke, intracerebral surgery, or other neuraxail procedures. Severe uncontrolled hypertension. Bacterial endocarditis. Hemorrhagic diathesis. Recent major surgery or major bleeding (eg, intracranial, GI, intraocular, or pulmonary). Active peptic ulcer. Advanced renal impairment. Monitor aPTT ratio and creatinine clearance prior to and during therapy. Hepatic impairment. Pregnancy (Cat.B). Nursing mothers: not recommended.
Concomitant thrombolytics (eg, rt-PA, streptokinase), drugs that affect platelets, coumarin derivatives: increase risk of bleeding and potentiate effect of lepirudin on aPTT prolongation.
Direct thrombin inhibitor (recombinant hirudin).
Bleeding, abnormal liver function, anaphylactic reactions (esp with re-exposure; may be fatal), multiorgan failure, antibody formation.