Direct healthcare professional communication on updates to strength expression, dose regimens in deep vein thrombosis / pulmonary embolism and use in patients with severe renal impairment for Clexane (enoxaparin sodium)
28.04.2017
sanofi-aventis Croatia d.o.o., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), has informed healthcare professionals of updates to strength expression, the information on dose regimens in deep vein thrombosis (DVT) / pulmonary embolism (PE) and the information on use in patients with severe renal impairment for Clexane (enoxaparin sodium).
Summary
- Enoxaparin strength has previously been expressed in international units (IU) of anti-Xa activity. It will now be expressed both in international units (IU) of anti-Xa activity and in milligram (mg). One mg of enoxaparin sodium is equivalent to 100 IU anti-Xa activity. For example, for the pre-filled syringes of 0.4 mL, the strength will appear as: Clexane 4000 IU (40 mg)/0.4 mL solution for injection.
- The dosage in treatment of DVT and PE has been clarified in detail. The regimen should be selected by the physician based on an individual assessment including evaluation of the thromboembolic risk and the bleeding risk. Enoxaparin sodium can be administered subcutaneously:
- as a once daily injection of 150 IU/kg (1.5 mg/kg): used in uncomplicated patients with low risk of VTE recurrence
- as twice daily injections of 100 IU/kg (1 mg/kg): used in all other patients such as those with obesity, with symptomatic PE, cancer, recurrent VTE or proximal (vena iliaca) thrombosis. - Contraindication in patients with severe renal impairment (creatinine clearance < 30 ml/min) was removed. For patients with creatinine clearance 15-30 ml/min dose adjustment is recommended. Use in patients with end stage kidney disease (creatinine clearance
Further information
Important discrepancies existed between European Union (EU) member states in the way enoxaparin strength was expressed in the product denomination and throughout the product information, the approved dosage regimen in DVT/PE and use in severe renal impairment.
Due to the specified reasons, a Europe-wide review has been conducted, within which the product information for Clexane (enoxaparin sodium) has been harmonised in all EU countries.
Here you may view the direct healthcare professional communication.
Healthcare professionals are reminded that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED. HALMED recommends patients to contact their doctor or pharmacist regarding any adverse reaction they notice.
