Danaparoid sodium

SCOPE - this is the HIT regimen, which is this page's primary indication (specialty Haematology, category 'Heparinoid (factor Xa inhibitor)', existing entry 'Per HIT protocol', BSH HIT guideline reference, anti-Xa target 0.5-0.8 units/mL). It covers the IV route only, which is the route the HIT regimen uses. VERBATIM (section 4.2 b) HIT patients): '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.' CORRECTION TO THE EXISTING PAGE: it states a 2,250-unit bolus; the SPC figure is 2,500 anti-Xa units. HIT DIAGNOSIS (section 4.2): 'The diagnosis of HIT should as a minimum be based on: 1) thrombocytopenia (platelet count<100x10 9 /L) occurring during heparin administration and 2) exclusion of all other causes of thrombocytopenia.' SC ROUTE, DIFFERENT INDICATION - recorded for completeness and explicitly NOT the dose above (section 4.2 a) Non-HIT patients, DVT prophylaxis): 'danaparoid sodium should be administered by subcutaneous injection at a dose of 750 U for patients less than or equal to 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.' CONVERSION TO ORAL ANTICOAGULANTS (section 4.2): oral anticoagulants can be given alongside the infusion at an infusion rate no greater than 300 units/h, and the infusion stopped once the INR is 1.5 or above; where the bleeding risk is high, either (a) stop the infusion and start 750 anti-Xa units subcutaneously twice a day, then 24 hours later start anticoagulants 48-72 hours before danaparoid is withdrawn, or (b) stop the infusion, give no further danaparoid, and start the anticoagulants 12 hours later - 'measurement of these parameters is not reliable within 5 hours of Danaparoid Sodium injection'. NO MAXIMUM DOSE is stated for the HIT regimen, so maxDose is deliberately left empty; the '(maximum rate 300units/h)' wording in the conversion paragraph is an infusion RATE cap, not a dose ceiling, and is not carried into maxDose. PAEDIATRIC (section 4.2, verbatim): 'Children: There is insufficient experience with the use of Danaparoid Sodium in children to suggest a dosage regimen for this group of patients.' paedDose is therefore null. ELDERLY (section 4.2): 'Clearance of anti-factor Xa activity has not been shown to be markedly reduced in the elderly and the usual dosage is recommended.' CARDIOPULMONARY BYPASS (section 4.4): 'Since severe bleeding may occur post-operatively in HIT patients undergoing a cardiopulmonary bypass procedure, danaparoid sodium is not recommended during the procedure, unless no other antithrombotic treatment is available.' CROSS-REACTIVITY (section 4.4): serological cross-reactivity with the heparin-induced antibody before therapy is approximately 5%, and clinical cross-reactivity developing during therapy is approximately 3% - the existing page's '~10%' figure is not supported by this bundle.