Dalteparin sodium

SOURCE: UK SPC (eMC) for Fragmin 10000 IU/0.4 ml solution for injection, §4.2 (https://www.medicines.org.uk/emc/product/4245/smpc). Monitoring of the anticoagulant effect is not usually necessary for the once-daily VTE treatment regimen. Simultaneous anticoagulation with vitamin K antagonists can be started immediately; Fragmin is continued until the prothrombin complex levels (Factors II, VII, IX and X) have decreased to a therapeutic level - at least five days of combined treatment is normally required. CANCER (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; by weight band 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 - platelets 50,000-100,000/mm3, reduce the daily dose by 2,500 IU until platelets recover to 100,000/mm3 or more; platelets under 50,000/mm3, discontinue until platelets recover above 50,000/mm3. Months 2-6 - platelets under 50,000/mm3, interrupt dosing until recovery above 50,000/mm3; platelets 50,000-100,000/mm3, use the SPC's reduced-dose table (scheduled 7,500 to 5,000; 10,000 to 7,500; 12,500 to 10,000; 15,000 to 12,500; 18,000 to 15,000 IU) and resume full dose once platelets are 100,000/mm3 or more. INCREASED BLEEDING RISK: the SPC recommends the twice-daily regimen detailed in the SPC for Fragmin 10,000 IU/1 ml ampoules or Fragmin Multidose Vial (not fetched). ELDERLY: Fragmin has been used safely in elderly patients without the need for dosage adjustment. This SPC section does not cover prophylaxis dosing or unstable coronary artery disease dosing - source those separately. §4.5 was not present in the fetched bundle; the interactions below come from §4.4 and from the US label.

SPC §4.2 - treatment of symptomatic VTE in paediatric patients 1 month of age and older. Starting doses vary by age band, so no single per-kg figure applies (dosePerKg left null deliberately): 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. A concentration of 2,500 IU/ml is recommended for the youngest cohort; dilution must be performed by a healthcare professional; for children under 3 years use a presentation without benzyl alcohol. Monitoring: measure anti-Xa 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 0.5-1 IU/ml, remeasuring after each adjustment; close monitoring where renal function is low/changing (e.g. neonates). Safety and efficacy for VTE PROPHYLAXIS in children has not been established and no posology recommendation can be made. Verify against a children's formulary.