a) Non-HIT patients (DVT prophylaxis) - In general, danaparoid sodium should be administered by subcutaneous injection at a dose of 750 U for patients ≤90 kg body weight, twice daily for a period of maximally 14 days unless it is required longer in patients for whom there is no reasonable antithrombotic alternative.
- For patients > 90 kg body weight, a dose of 750 U three times a day or 1250 U twice a day is recommended. - In surgical patients it is recommended to start this dosing pre-operatively and to give the last pre-operative dose 1-4 hours before surgery.
Monitoring Plasma anti-Xa activity is linearly related to the dose of danaparoid sodium given. In general, monitoring of plasma anti-Xa activity is not necessary. If monitoring of anticoagulant activity is performed then a functional anti-factor Xa test using a chromogenic peptide substrate should be used.
In this test danaparoid sodium should be used as standard for constructing the reference curve. Renal impairment and patients >90kg In patients suffering from renal insufficiency and/or patients > 90kg body weight monitoring, once or twice a week during routine subcutaneous therapy, (using an amidolytic assay) is recommended to check for drug accumulation or underdosing, respectively.
b) HIT patients The diagnosis of HIT should as a minimum be based on: 1) thrombocytopenia (platelet count<100x109/L) occurring during heparin administration and 2) exclusion of all other causes of thrombocytopenia In general monitoring of plasma anti-Xa activity is not necessary.
However, in patients suffering from renal insufficiency and/or patients weighing over 90kg, monitoring (using an amidolytic assay) is recommended. Danaparoid Sodium should be administered intravenously as a bolus of 2500 anti-Xa units (for patients less than 55kg 1250 units, if over 90kg, 3750 units) followed by an intravenous infusion of 400units/h for 2 hours, then 300 units/h for 2 hours, then a maintenance infusion of 200 units/h for 5 days.
8 units/ml during the maintenance infusion.
Dosage in the elderly:
Clearance of anti-factor Xa activity has not been shown to be markedly reduced in the elderly and the usual dosage is recommended.
Children:
There is insufficient experience with the use of Danaparoid Sodium in children to suggest a dosage regimen for this group of patients.
Dosage in patients with moderately impaired renal and/or liver function:
Danaparoid Sodium should be used with caution in patients with moderately impaired renal and/or liver function with impaired haemostasis. Conversion to anticoagulants is possible, however it is advisable only to start such a therapy once there is adequate antithrombotic control with Danaparoid Sodium.
5. 6 ml subcutaneously twice a day, then 24 hours later start anticoagulants 48-72 hours before Danaparoid Sodium is withdrawn to give time for the prothrombin time, Thrombotest and international normalised ratio to reach therapeutic levels (measurement of these parameters is not reliable within 5 hours of Danaparoid Sodium injection (See “Interactions with other medicaments and other forms of interactions”)) or (b) stop the infusion, give no further Danaparoid Sodium then start the anticoagulants 12 hours later.