Fraxiparine Special Precautions





Zuellig Pharma
Full Prescribing Info
Special Precautions
Heparin-induced Thrombocytopenia: Because of the possibility of heparin-induced thrombocytopenia, platelet count should be monitored throughout the course of treatment with nadroparin.
Rare cases of thrombocytopenia, occasionally severe, have been reported, which may be associated with arterial or venous thrombosis. Such diagnosis should be considered in the following situations: thrombocytopenia; any significant reduction in platelet level (30 to 50% compared with the baseline value); worsening of the initial thrombosis while on therapy; thrombosis occurring on treatment; disseminated intravascular coagulation.
In this event, nadroparin treatment must be discontinued.
These effects are probably of an immuno-allergic nature and in the case of a first treatment are reported mainly between the 5th and the 21st day of therapy, but may occur much earlier if there is a history of heparin-induced thrombocytopenia.
If there is a history of thrombocytopenia occurring with heparin (either standard or low molecular weight heparin), treatment with nadroparin may be considered if necessary. In such cases, careful clinical monitoring and assessment of platelet count should be performed at least daily. If thrombocytopenia occurs, treatment should be discontinued immediately.
When thrombocytopenia occurs with heparin (either standard or low molecular weight heparin), substitution with a different antithrombotic class should be considered. If not available, then substitution with another low molecular weight heparin may be considered if the administration of heparin is necessary. In such cases, platelet count monitoring should be performed at least daily and the treatment should be discontinued as soon as possible, since cases of initial thrombocytopenia continuing after substitution have been described (see Contraindications).
In vitro platelet aggregation tests are only of limited value in the diagnosis of heparin-induced thrombocytopenia.
Caution should be exercised when nadroparin is administered in the following situations as they may be associated with an increased risk of bleeding: hepatic failure; severe arterial hypertension; history of peptic ulceration or other organic lesion likely to bleed; vascular disorder of the chorio-retina; during the post-operative period following surgery of the brain, spinal cord or eye.
Renal Impairment: Nadroparin is known to be mainly excreted by the kidney, which results in increased nadroparin exposure in patients with renal impairment (see Pharmacology: Pharmacokinetics: Renal Impairment under Actions). Patients with impaired renal function are at increased risk of bleeding and should be treated with caution.
The decision on whether a dose reduction is appropriate for patients with creatinine clearance 30 to 50 ml/min should be based on the physician's assessment of an individual patient's risk of bleeding versus the risk of thromboembolism (see Dosage & Administration).
Hyperkalaemia: Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients with raised plasma potassium, or at risk of increased plasma potassium levels, such as patients with diabetes mellitus, chronic renal failure, pre-existing metabolic acidosis or those taking drugs that may cause hyperkalaemia (e.g. angiotensin-converting (ACE) inhibitors, Nonsteroidal anti-inflammatory drugs (NSAIDs)).
The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible.
Plasma potassium should be monitored in patients at risk.
Spinal/epidural anaesthesia/spinal lumbar puncture and concomitant drugs: The risk of spinal/epidural haematomas is increased by in-dwelling epidural catheters or by the concomitant use of other drugs which may affect haemostasis, such as NSAIDs, platelet inhibitors, or other anticoagulants. The risk also appears to be increased by traumatic or repeated epidural or spinal puncture.
Therefore, the concomitant prescription of a neuraxial blockade and of an anticoagulant therapy should be decided after careful individual benefit/risk assessment in the following situations: in patients already treated with anticoagulants, the benefits of a neuraxial blockade must be carefully balanced against the risks; in patients planned to undergo elective surgery with neuraxial blockade, the benefits of anticoagulant therapy must be carefully balanced against the risks.
In the case of patients with spinal lumbar puncture, spinal anaesthesia or epidural anaesthesia, a minimum of 12 hours should elapse between the nadroparin injection at prophylactic doses or 24 hours at treatment doses and the insertion or the removal of the spinal/epidural catheter or needle. For patients with renal impairment longer intervals may be considered.
Patients should be frequently monitored for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary.
Salicylates, non-steroidal anti-inflammatory and anti-platelet drugs: In the prophylaxis or treatment of venous thromboembolic disorders and in the prevention of clotting during haemodialysis, the concomitant use of aspirin, other salicylates, NSAIDs, and anti-platelet agents is not recommended, as they may increase the risk of bleeding. Where such combinations cannot be avoided, careful clinical and biological monitoring should be undertaken.
In clinical studies for the treatment of unstable angina and non-Q wave myocardial infarction, nadroparin was administered in combination with up to 325 mg aspirin per day (see Dosage & Administration).
Cutaneous Necrosis: Cutaneous necrosis has been reported very rarely. It is preceded by purpura or infiltrated or painful erythematous blotches, with or without general signs. In such cases, treatment should be immediately discontinued.
Latex Allergy: The needle shield of the pre-filled syringe may contain dry natural latex rubber that has the potential to cause severe allergic reactions in latex sensitive individuals.
Effects on Ability to Drive and Use Machines: There are no data on the effects of nadroparin on driving performance or the ability to operate machinery.
Use in Elderly: It is recommended that renal function is assessed before initiating treatment (see Contraindications).
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