Use in patients with renal impairment

Since LMWHs are eliminated predominantly via the kidneys, drug accumulation risk exists in patients with renal function impairment. Clexane® has been investigated in studies in patients with renal function impairment of various severity grades, and the Summary of Product Characteristics offers clear recommendations for dosing [46].

In the steady-state, linear correlation exists between the anti-Xa plasma clearance and creatinine clearance, which indicates decreased clearance of Clexane® in patients with impaired renal function. In mild to moderate renal function impairment (creatinine clearance 50–80 ml/min or 30–50 ml/min), in the steady state after repeated subcutaneous administration of 40 mg per day the anti-Xa exposition measured as AUC is slightly increased. In those with moderate and mild renal impairment, although no dosage adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine clearance 50-80 ml/min), careful clinical monitoring is advised.

In patients with severe renal function impairment (creatinine clearance 15-30 ml/min), in the steady state after repeated subcutaneous administration of 40 mg per day, the AUC is significantly increased by an average of 65%. Therefore, in patients with severe renal failure, the dose of Clexane® needs to be adjusted, as per the table below [46].

Indication Dosing regimen
Prophylaxis of venous thromboembolic disease 2,000 IU (20 mg) SC once daily
Treatment of DVT and PE 100 IU/kg (1 mg/kg) body weight SC once daily
Treatment of unstable angina and NSTEMI 100 IU/kg (1 mg/kg) body weight SC once daily
Treatment of acute STEMI (patients under 75) 1 x 3,000 IU (30 mg) IV bolus plus 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
Treatment of acute STEMI (patients over 75)  No IV initial bolus, 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours

SC, subcutaneous; IV, intravenous;

The recommended dosage adjustments do not apply to the haemodialysis indication