Information on how to access Fragmin® (dalteparin sodium) prescribing information and adverse event reporting can be found at the bottom of the page.
Active malignancy is associated with a 4–7 fold increase in venous thromboembolism (VTE) compared to patients without cancer1,2. Approximately 15% of patients with cancer develop future symptomatic VTE, and those with idiopathic VTE have up to a 4-fold increased risk of malignancy in the first year after VTE diagnosis.2 These cancers are likely to be advanced and are associated with a 3-fold increase in mortality2. For these patients, anticoagulation is an important consideration
The extended treatment of symptomatic VTE and prevention of its recurrence in patients with solid tumours3
Recommended duration of treatment is 6 months; continuing treatment beyond this period should be evaluated according to individual risk/benefit ratio, taking into account the progression of cancer.
NICE clinical guidelines recommend offering low molecular weight heparins, such as Fragmin, to patients with active cancer and confirmed proximal deep vein thrombosis (DVT) or pulmonary embolism (PE) for 6 months. At 6 months, the patient should be reevaluated4
Once-daily, weight-adjusted monotherapy for 6 months3
Maximum daily dose – 18,000 IU**≈
No dose adjustment in the elderly
Dose adjustments are required in patients with low platelet counts. For further information about dose reduction or interruption in patients with chemotherapy -induced thrombocytopenia, please refer to SPC.
Platelets should be measured before starting Fragmin and monitored closely in the first 3 weeks and regularly thereafter during treatment3
Monitoring of the anticoagulant effect is not usually necessary3
In the case of significant renal failure (defined as CrCl <30 ml/min), the dose of Fragmin should be adjusted based on anti-factor Xa activity
Please refer to the SmPC for monitoring within specific patient groups
**Maximum dose of 18,000 IU was used in patients weighing up to 132 kg in the Fragmin CLOT study3.
≈In cancer patients with body weight <40 kg at time of venous thromboembolic event, Fragmin should not be used for extended treatment of symptomatic VTE and prevention of its recurrences due to lack of data3.
Limited data are available regarding the safety and efficacy of antithrombotic therapy in patients with primary or metastatic tumours of the brain who develop concurrent thromboembolic events. There is a isk of fatal intracranial bleeding with use of anticoagulation in this category of patients. Therefore, if the treatment with Fragmin was considered, it should be monitored closely with regular re-assessment of the status of the tumour involvement of the brain and other individual risks.
For further information please refer to SPC.
Fragmin (dalteparin sodium) 10,000 IU/0.4ml solution for injection
Fragmin (dalteparin sodium) 10,000 IU/1 ml solution for injection
Fragmin (dalteparin sodium) 10,000 IU/4ml solution for injection
Fragmin (dalteparin sodium) 100,000 IU / 4ml Multidose Vial solution for injection
Fragmin (dalteparin sodium) 12,500 IU/0.5ml solution for injection
Fragmin (dalteparin sodium) 15,000 IU/0.6ml solution for injection
Fragmin (dalteparin sodium) 18,000 IU/0.72ml solution for injection
Fragmin (dalteparin sodium) 2500 IU solution for injection
Fragmin (dalteparin sodium) 5000 IU solution for injection
Fragmin (dalteparin sodium) 7,500 IU/0.3 ml solution for injection
Fragmin (dalteparin sodium) Graduated Syringe 10,000 IU/ml Solution for Injection
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PP-PFE-GBR-2688. December 2020