Quantification: The concentrations of the various low molecular weight heparins are expressed using different systems, i.e. non equivalent units or mg. Special care is therefore required and the specific instructions for each product should be followed exactly.
Risk of hemorrhage: The recommended dosage regimens must be respected (dosage and duration of treatment). Failure to comply with these recommendations can lead to hemorrhage, particularly in high-risk patients (the elderly, patients with renal failure, etc.)
Serious hemorrhage events have been reported in the following situations: Elderly subjects, particularly due to age-related renal impairment; patients with renal failure; bodyweight below 40 kg; treatment lasting longer than the recommended mean duration of ten days; non-compliance with therapeutic recommendations; co-administration with drug increasing the risk of hemorrhage.
In any event, special monitoring is indispensable in the elderly and/or patients with renal failure, as well as during treatment for more than ten days.
Assay of anti-Xa activity may in certain cases be useful in detecting accumulation.
Risk of heparin-induced thrombocytopenia (HIT): Should a patient treated with LMWH (curative or preventive dose) develop thromboembolic complications such as: exacerbation of the thrombosis being treated; phlebitis; pulmonary embolism; acute ischemia of the lower limbs; or even myocardial infarction or ischemic stroke.
HIT should systematically be suspected and a platelet count performed urgently.
Use in children: As no relevant data are available, use of LHWH is not recommended in children.
2000/4000 Anti-Xa IU: Spinal/epidural anesthesia: As with other anticoagulants, there have been rare reports of spinal haematomas following the administration of enoxaparin during spinal/epidural anesthesia, resulting in long-term or permanent paralysis. The risk of these rare events may be increased by prolonged use of postoperative indwelling epidural catheters.
Mechanical prosthetic heart valves: The use of enoxaparin in the prevention of thromboembolic events in patients with mechanical prosthetic heart has not been specifically investigated. However, some isolated cases of thrombosis have been reported in patients with this devise who received enoxaparin as prophylactic treatment of thomboembolic events.
Pregnant women: During a clinical study in pregnant women with mechanical prosthetic heart valves receiving 100 anti-Xa IU/kg bodyweight of enoxaparin twice daily to reduce the risk of thromboembolic events, two of eight women developed thrombosis which led to an obstructed valve with fatal outcome for both the woman and the fetus. In addition, other isolated post-marketing cases of thrombosis have been reported in pregnant women with mechanical prosthetic heart valves who received thromboembolic prophylaxis with enoxaparin. Therefore, the risk of thromboembolic events in this population might be higher.
4000 Anti-Xa IU: Prophylactic treatment in acute medical conditions: In the event of an acute episode of infection or bone-joint disease, prophylactic treatment is only justified if the condition is associated with at least one of the following venous thromboembolic risk factor: age >75 years; cancer; history of venous thromboembolism; obesity; hormone therapy; heart failure; chronic respiratory failure.
In medical prophylaxis, there is very limited clinical experience in elderly patients over 80 years of age whose bodyweight is below 40 kg.
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