MI L Volume 7, No. 10 October 2014 This Medicines Information Leaflet is produced locally to optimise the use of medicines by encouraging prescribing that is safe, clinically appropriate and cost-effective to the NHS. Treatment of VTE with dalteparin (Fragmin®) in patients with cancer E vidence has shown that patients with active cancer, or patients undergoing cancer treatment have lower rates of VTE recurrence when treated with low molecular weight heparin (LMWH) instead of warfarin, without increasing the risk of bleeding. This document focuses on the doses of subcutaneous dalteparin for cancer patients, and which patients should be excluded from this regimen. For all other clinical information with respect to dalteparin for the treatment of VTE, please see MIL Vol 2 No 2 Treatment of venous thromboembolism (VTE) in adults with dalteparin (Fragmin®). Patient exclusions For patients to be considered for extended treatment with dalteparin, they must be able to self-inject, or have a carer who can inject for them. If they are not able to, they will be treated as for non-cancer patients. Patients with significant renal impairment (creatinine clearance less than 30mL/min) should be discussed with a Haematology SpR (bleep 5529). Patients who weigh less than 40kg are excluded from the product license and should be discussed with a Haematology SpR (bleep 5529) before extended treatment is initiated. Dose and administration Month 1 Body weight (kg) Less than 46 Dose (units) 7,500 once daily 46-56 10,000 once daily 57-68 12,500 once daily 69-82 15,000 once daily 83-120 18,000 once daily 121-131 12,500 twice daily 132-143 15,000 mane & 12,500 nocte 144-157 15,00 twice daily 158-172 18,000 mane & 15,000 nocte More than 172 18,000 twice daily Medicines Management and Therapeutics Committee Oxford University Hospitals In the case of chemotherapy-induced thrombocytopenia, the dose should be adopted as follows: 9 For platelet counts between 50-100 x 10 /L, the manufacturer recommends that the dose should be reduced by 2,500units until the platelet count recovers 9 to greater than or equal to 100 x 10 /l. However, a risk benefit assessment may favour continuing full dose anticoagulation. 9 For platelet counts below 50 x 10 /L, the manufacturer suggests that dalteparin should be withheld until the platelet count recovers to greater than or equal to 50 x 9 10 /L. However, a risk benefit assessment may favour continuing a 50% dose of dalteparin for counts between 9 25 and 50 x 10 /L. If anticoagulation is discontinued an IVC filter should be considered. Months 2-6 Body weight (kg) Less than 57 Dose (units) 7,500 once daily 57-68 10,000 once daily 69-82 12,500 once daily 83-98 15,000 once daily More than 98 18,000 once daily In the case of chemotherapy-induced thrombocytopenia in the extended treatment phase (months 2-6, consult product literature or contact Haematology for advice on bleep 5529). Duration of treatment Licensed duration of treatment is 6 months. A local shared-care agreement exists between primary and secondary care for supplying dalteparin. For patients in whom long term anticoagulation is indicated, discuss with the haematology registrar/consultant at the Oxford Anticoagulation Service. References 1. Lee AYY et al Low molecular weight heparin versus a coumarin for the prevention of recurrent venous thromboembolism in patients with cancer. NEJM 349 146-153 2. Summary of Product Characteristics (SPC) for dalteparin (Fragmin®), Pfizer limited. Accessed via www.medicines.org.uk 18th October 2014 October 2014 2 3. British National Formulary (BNF) 63rd Ed. British Medical Association and the Royal Pharmaceutical Society of Great Britain, London, UK. March 2014 4. Venous thromboembolic diseases: the management of venous thromboembolic diseases and the role of thrombophilia testing NICE CG144, June 2012 5. Antithrombotic and Thrombolytic Therapy, 9th Ed: ACCP Guidelines. Chest 141 supplement, 2012 Prepared by: Vicki Price, Lead Pharmacist, Anticoagulation & Thrombosis Pharmacist & Dr. David Keeling, Consultant Haematologist Review date: October 2017 Medicines Information Leaflet