Dalteparin

UNITS ARE INTERNATIONAL UNITS (IU) OF ANTI-FACTOR Xa ACTIVITY, NOT MILLIGRAMS. Fetched product: Fragmin 10,000 IU/0.4 ml solution for injection. Monitoring of the anticoagulant effect is not usually necessary for the standard adult treatment regimen. Simultaneous anticoagulation with a vitamin K antagonist can be started immediately; continue Fragmin until prothrombin complex levels (Factors II, VII, IX and X) reach a therapeutic level — at least five days of combined treatment is normally required. PATIENTS WITH SOLID TUMOURS (extended treatment of symptomatic VTE and prevention of recurrence): Month 1 — 200 IU/kg total body weight subcutaneously once daily for the first 30 days, total daily dose not to exceed 18,000 IU (weight bands: under 46 kg 7,500 IU; 46-56 kg 10,000 IU; 57-68 kg 12,500 IU; 69-82 kg 15,000 IU; 83 kg and over 18,000 IU). Months 2-6 — approximately 150 IU/kg subcutaneously once daily using fixed-dose syringes (56 kg or less 7,500 IU; 57-68 kg 10,000 IU; 69-82 kg 12,500 IU; 83-98 kg 15,000 IU; 99 kg or more 18,000 IU); recommended total duration 6 months including the first month. CHEMOTHERAPY-INDUCED THROMBOCYTOPENIA: month 1 — if platelets are 50,000-100,000/mm3 reduce the daily dose by 2,500 IU until platelets recover to 100,000/mm3 or more, and if platelets are below 50,000/mm3 discontinue until they recover above 50,000/mm3; months 2-6 — interrupt if platelets are below 50,000/mm3, and for platelets 50,000-100,000/mm3 reduce per the SPC table (7,500 to 5,000 IU; 10,000 to 7,500 IU; 12,500 to 10,000 IU; 15,000 to 12,500 IU; 18,000 to 15,000 IU), returning to full dose once platelets recover to 100,000/mm3 or more. TWICE-DAILY REGIMEN: for patients at increased risk of bleeding, Fragmin should be given per the twice-daily regimen detailed in the SPC for the Fragmin 10,000 IU/1 ml ampoules or the multidose vial (that regimen was not part of this fetch). PLATELET MONITORING: measure platelet count before starting, monitor closely for the first three weeks and regularly thereafter. Prolongation of the APTT should be used only as a test of overdosage, not for dose titration. US labelling (different indications/units terminology, for cross-reference only): unstable angina and non-Q-wave MI — 120 units/kg subcutaneously every 12 hours with aspirin, maximum 10,000 units per dose; DVT prophylaxis — 2,500 or 5,000 units subcutaneously once daily depending on surgical/medical setting. ELDERLY: used safely without dose adjustment.

UNITS ARE INTERNATIONAL UNITS (IU) PER KG, NOT MILLIGRAMS. dosePerKg is deliberately null because the SPC states THREE different age-banded per-kg starting doses, not one: 1 month to less than 2 years — 150 IU/kg twice daily; 2 years to less than 8 years — 125 IU/kg twice daily; 8 years to less than 18 years — 100 IU/kg twice daily. MONITORING: measure anti-Xa level after the first, second or third dose, sampled 4 hours after administration; adjust in increments of 25 IU/kg to a target anti-Xa of 0.5 to 1 IU/ml, re-measuring after each adjustment, and continue periodically once a maintenance dose is established. In the youngest children start monitoring after the first dose and monitor more frequently; in neonates, where renal function is low and changing, close anti-Xa monitoring is warranted. FORMULATION SAFETY: a 2,500 IU/ml concentration is recommended for accuracy in the youngest cohort and dilution must be performed by a healthcare professional; the 10,000 IU/ml and 25,000 IU/ml multidose vials contain benzyl alcohol and a preservative-free presentation must be used in children under 3 years. Final injection volume should be between 0.15 ml and 1.0 ml. PROPHYLAXIS: safety and efficacy of dalteparin for VTE prophylaxis in children has not been established and no posology recommendation can be made. Verify against a children's formulary before use.