Interactions

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 [42].

A linear relationship exists between anti-Xa plasma clearance and creatinine clearance at steady-state has been observed, which indicates decreased clearance of enoxaparin sodium in patients with reduced renal function. Anti-Xa exposure represented by AUC, at steady-state is marginally increased in mild (creatinine clearance 50-80ml/min) and moderate (creatinine clearance 30-50ml/min) renal impairment after repeated subcutaneous 40mg once daily doses. In patients with severe renal impairment (creatinine clearance<30ml/min), the AUC at steady state is significantly increased on average by 65% after repeated subcutaneous 40mg once daily doses.

In patients with severe renal function impairment (creatinine clearance <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 enoxaparin needs to be adjusted, as per the table below [42].

Standard dosing Severe renal impairment
1 mg/kg SC twice daily 1 mg/kg SC once daily
1.5 mg/kg SC once daily 1 mg/kg SC once daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus* plus a 1mg/kg SC dose followed by 1mg/kg twice daily

(Max 100mg for each of the first two SC doses)
30mg-single IV bolus* plus a 1mg/kg SC dose followed by 1mg/kg once daily

(Max 100mg for first SC dose only)
For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial bolus

(Max 75mg for each of the first two SC doses)
1mg/kg SC once daily without initial bolus

(Max 100mg for first SC dose only)

Dosage adjustments for prophylactic dosage ranges

Standard dosing Severe renal impairment
40 mg SC once daily 20 mg SC once daily
20 mg SC once daily 20 mg SC once daily

*The Clexane 60mg, 80mg or 100mg pre-filled syringes should be used to administer the IV dose.