Bemiparin interacts in the following cases:
Caution should be exercised in patients with liver failure, uncontrolled arterial hypertension, history of gastro-duodenal ulcer disease, thrombocytopenia, nephrolithiasis and/or urethrolithiasis, choroid and retinal vascular disease, or any other organic lesion with an increased risk of bleeding complications, or in patients undergoing spinal or epidural anaesthesia and/or lumbar puncture.
In mild or moderate renal impairment (creatinine clearance 30-80 ml/min) no dose adjustment is necessary, although caution should be exercised.
The kinetics of bemiparin may be affected in patients with severe renal impairment (creatinine clearance <30 mL/min). Regular monitoring is recommended in this population, especially when therapeutic doses are administered. After a careful assessment of the individual bleeding and thrombotic risks, the dose may be necessary to be adjusted.
Medicinal products that increase the serum potassium concentration should only be taken concomitantly under especially careful medical supervision.
The concomitant administration of bemiparin and the following medicinal products is not advisable:
Vitamin K antagonists and other anticoagulants, acetyl salicylic acid and other salicylates and NSAIDs, ticlopidine, clopidogrel and other platelet inhibitors systemic glucocorticoids and dextran.
All these drugs increase the pharmacological effect of bemiparin by interfering with its action on coagulation and/or platelet function and increasing the risk of bleeding.
If the combination cannot be avoided, it should be used with careful clinical and laboratory monitoring.
Interaction of heparin with intravenous nitroglycerine (which can result in a decrease in efficacy) cannot be ruled out for bemiparin.
Bemiparin, like other LMWHs, can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis, a raised plasma potassium or those taking potassium sparing drugs. The risk of hyperkalaemia appears to increase with the duration of therapy but is usually reversible. Serum electrolytes should be measured in patients at risk before starting bemiparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond 7 days.
Animal studies have not shown any evidence of teratogenic effects with the use of bemiparin. For bemiparin, no clinical data on exposed pregnancies are available. Therefore, caution should be exercised when prescribing to pregnant women. It is unknown whether bemiparin crosses placental barrier.
Insufficient information is available as to whether bemiparin passes into breast milk. Therefore, where it is necessary for lactating mothers to receive bemiparin, they should be advised to avoid breast-feeding.
Bemiparin has no or negligible influence on the ability to drive and use machines.
The most commonly reported adverse reaction is haematoma and/or ecchymosis at the injection site, occurring in approximately 15% of patients receiving bemiparin.
Osteoporosis has been associated with long-term heparin treatment.
The undesirable effects are listed by system organ class and frequency: very common (>1/10), common (>1/100 to <1/10), uncommon (>1/1,000 to <1/100), rare (>1/10,000 to <1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data):
The frequency of adverse events (AEs) reported with bemiparin is similar to those reported with other LMWHs and is as follows:
Common: Bleeding complications (skin, mucous membranes, wounds, gastro-intestinal tract, urogenital tract)
Uncommon: Mild and transient thrombocytopenia (HIT type I)
Rare: Severe thrombocytopenia (type II)
Uncommon: Cutaneous allergic reactions (urticaria, pruritus)
Rare: Anaphylactic reactions (nausea, vomiting, fever, dyspnea, bronchospasm, glottis oedema, hypotension, urticaria, pruritus)
Not known (cannot be estimated from the available data): Hyperkalemia
Common: Mild and transient elevations of transaminases (ASAT, ALAT) and gamma-GT levels.
Rare: Cutaneous necrosis at the injection site.
Very common: Ecchymosis at injection site, Haematoma and pain at injection site.
Rare: Epidural and spinal haematomas following epidural or spinal anaesthesia and lumbar puncture. These haematomas have caused various degrees of neurological impairment, including prolonged or permanent paralysis
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