Clexane Special Precautions

Low-molecular weight heparin products are not clinically interchangeable.
The biological activity of different low-molecular weight heparin cannot be expressed in a test allowing for a simple dose comparison. Different low-molecular weight heparin may not be bioequivalent in terms of their labelled anti-Xa activities and alternative products should not be introduced nor interchanged during a course of treatment.
Enoxaparin is to be used with extreme care in patients with a history of heparin-induced (including low-molecular weight heparins) thrombocytopaenia with or without thrombosis. The risk of heparin-induced thrombocytopaenia may persist for several years. If history of heparin-induced thrombocytopaenia is suspected, in vitro platelet aggregation tests have limited predictive value. The decision to use enoxaparin in such a case must be made only in consultation with an expert in the field.
Not to be administered by IM route.
Clexane should be used with care in patients with the following conditions: Hepatic insufficiency, uncontrolled arterial hypertension, a history of gastrointestinal ulceration, impaired haemostasis, recent ischaemic stroke, diabetic retinopathy and recent neuro- or ophthalmologic surgery.
In severe renal failure, despite evidence that the pharmacokinetics of Clexane is unchanged, the extent to which the platelet function defect in severe renal failure might contribute to bleeding risk during long-term therapy is unknown.
If a transmural myocardial infarction occurs in a patient being treated with enoxaparin for unstable angina or non-Q-wave myocardial infarction, thrombolytic treatment may be appropriate.
Use in Pregnancy: Pregnancy Category C: Animal toxicity studies have shown that enoxaparin may have some effect on rat and rabbit reproduction.
There is no information available concerning the use of Clexane during the 1st and 3rd trimesters. As there are no adequate and well-controlled studies in pregnant women and because animal studies are not always predictive of human response, this drug should be used during pregnancy only if the physician has established a clear need.
Use in Lactation: Studies performed in female rats demonstrated that enoxaparin had no effect on lactation or milk composition. Effects of Clexane on lactating women have not been studied.
As a precaution, women should be advised not to breastfeed while using Clexane.