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CLEXANE (enoxaparin)

Notice type: 3rd Party Publications

Date: 30/04/2006

  

Product name or type:
CLexane (Enoxaparin) MIMS Advisory

Reference:
MIMS Publication April 2006

Problem Or Issue:
Clexane is a low molecular weight heparin authorised in Ireland for the following indications:
 
- The prophylaxis of thromboembolic disorders of venous origin, in particular those which may be associated with orthopaedic or general surgery. 

- The prophylaxis of venous thromboembolism in medical patients bedridden due to acute illnesses including cardiac insufficiency, respiratory failure, or severe infections. 

- The treatment of venous thromboembolic disease presenting with deep vein thrombosis, pulmonary embolism or both. 

- The treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. 

- The prevention of thrombus formation in the extracorporeal circulation during haemodialysis. 

The Irish Medicines Board (IMB) recently instructed the product authorisation holder, sanofi-aventis, to recall a specific batch of Clexane Syringes 80mg/0.8ml from the Irish market due to concerns regarding the potential for over-concentration of up to 50% of the active substance, enoxaparin, in a number of syringes. 

As a follow on from this recent recall, the IMB would like to take the opportunity to highlight the potential risk of serious bleeding with Clexane and to remind prescribers of the following:
 
• Bleeding may occur during Clexane therapy with or without the presence of associated risk factors. The origin of the bleeding should be investigated and appropriate treatment instituted. Major haemorrhage, including retroperitoneal and intracranial bleeding, has been reported. 

• Clexane injection should only be used with great caution in conditions with increased potential for bleeding. 

• Regular platelet count monitoring should be considered prior to and during therapy with these agents. Thrombocytopenia, should it occur, usually appears between the 5th and 21st day following the beginning of therapy and may be complicated by thrombosis. If the platelet count is significantly reduced (30 to 50% of the initial value) or thrombosis occurs, therapy must be discontinued immediately and an alternative therapy initiated. 

• Agents which affect haemostasis should be discontinued prior to Clexane therapy unless their use is essential. If the combination cannot be avoided, Clexane should be used with careful clinical and laboratory monitoring.
 
• Careful clinical monitoring is advised in elderly patients who may be at an increased risk for bleeding complications with the therapeutic dosage ranges, in patients with renal impairment and in low-weight men and women. 

• Patients treated outside the hospital setting and their caregivers should be informed of the possibility of serious side effects and should be encouraged to report bleeding at the earliest signs. 

Any suspected adverse reactions should be reported to the IMB in the usual way. 

A downloadable version of the ADR report form is available from the HPRA’s website (www.hpra.ie). Downloaded forms may be completed and sent by freepost to the HPRA. Envelopes should be marked “Freepost”, Pharmacovigilance Unit, Health Products Regulatory Authority, The Earlsfort Centre, Earlsfort Terrace, Dublin 2. Alternatively, completed forms may be submitted by fax (01- 6762517). Post-paid report cards are also available from the Pharmacovigilance Unit at the HPRA (01- 6764971).

Background Information Or Related Documents:
CLEXANE (enoxaparin) Document

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