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FRAGMIN is a brand name for Dalteparin. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of venous thromboembolism (VTE) presenting clinically as deep vein thrombosis (DVT), pulmonary embolism (PE) or both. Patients with solid tumours: Extended treatment of symptomatic venous thromboembolism (VTE) and prevention of its recurrence. Paediatric population Treatment of symptomatic venous…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment of venous thromboembolism (VTE) presenting clinically as deep vein thrombosis (DVT), pulmonary embolism (PE) or both: Adults A single dose of Fragmin is administered subcutaneously, once daily according to the following weight ranges.
Monitoring of the anticoagulant effect is not usually necessary. Weight (kg) Dose 46-56 10,000 IU 57-68 12,500 IU 69-82 15,000 IU 83 and over 18,000 IU Abbreviations: IU = International Unit The single daily dose should not exceed 18 000 IU.
Simultaneous anti-coagulation with vitamin K antagonists can be started immediately. Treatment with Fragmin is continued until the prothrombin complex levels (Factor II, VII, IX and X) have decreased to a therapeutic level. At least five days of combined treatment is normally required.
Patients with solid tumours:
Extended treatment of symptomatic venous thromboembolism (VTE) and prevention of its recurrence. Month 1 Administer Fragmin 200 IU/kg total body weight subcutaneously (SC) once daily for the first 30 days of treatment. The total daily dose should not exceed 18,000 IU daily.
Body Weight (kg) Dose (IU) <46 7 500 46-56 10 000 57-68 12 500 69-82 15 000 83 and over 18 000* * Maximum dose of 18, 000 IU was used in patient weighing up to 132 kg in the CLOT study. In the case of chemotherapy-induced thrombocytopenia, Fragmin dose should be adopted as follows: - In patients receiving Fragmin who experience platelet counts between 50,000 and 100,000/mm3, the daily dose of Fragmin should be reduced by 2,500 IU until the platelet count recovers to ≥100,000/mm3.
- In patients receiving Fragmin who experience platelet counts <50,000/mm3, Fragmin should be discontinued until the platelet count recovers above 50,000/mm3. Months 2-6 Fragmin should be administered at a dose of approximately 150 IU/kg, subcutaneously, once daily using fixed dose syringes and the table shown below.
Body Weight (kg) Dose (IU) ≤56 7 500 57 to 68 10 000 69 to 82 12 500 83 to 98 15 000 ≥99 18 000 Recommended duration of treatment is 6 months (first month of Fragmin treatment is included). Relevance of continuing treatment beyond this period will be evaluated according to individual risk/benefit ratio, taking into account particularly the progression of cancer.
About 3% of the patients having had prophylactic treatment reported side-effects. The reported adverse reactions, which may possibly be associated to dalteparin sodium, are listed in the following table by system organ class and frequency group: common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10 000).
System Organ Class Frequency Adverse reactions Common Mild thrombocytopenia (type I), which usually is reversible during the treatment Blood and lymphatic system disorders Not Known* Immunologically-mediated heparin- induced thrombocytopenia (type II, with or without associated thrombotic complications) Uncommon Hypersensitivity Immune system disorders Not Known* Anaphylactic reactions Metabolism and nutrition disorders Common Hyperkalaemia Nervous system disorders Not Known* Intracranial bleeds have been reported and some have been fatal Cardiac disorders Not Known* Prosthetic cardiac valve thrombosis Vascular disorders Common Haemorrhage Gastrointestinal disorders Not Known* Retroperitoneal bleeds have been reported and some have been fatal Hepatic and biliary disorders Common Transient elevation of transaminases Uncommon Urticaria, pruritus Rare Skin necrosis, transient alopecia Skin and subcutaneous tissue disorders Not Known* Rash Musculoskeletal and connective tissue disorders Uncommon Osteoporosis (in connection with long-term treatment) General disorders and administration site conditions Common Subcutaneous haematoma at the injection site Pain at the injection site Injury, Poisoning and Procedural Complications Not Known* Spinal or epidural hematoma *(cannot be established from available data) The risk of bleeding is depending on dose.
Most bleedings are mild. Severe bleedings have been reported, some cases with fatal outcome. Heparin products can cause hypoaldosteronism which may result in an increase in plasma potassium. 4). Long term treatment with heparin has been associated with a risk of osteoporosis.
Do not administer by the intramuscular route. Due to the risk of haematoma, intramuscular injection of other medical preparations should be avoided when the twenty-four hour dose of dalteparin exceeds 5,000 IU. g. 5). Caution shall also be observed at high-dose treatment with dalteparin (such as those needed to treat acute deep-vein thrombosis, pulmonary embolism, and unstable coronary artery disease).
The concomitant use with drugs affecting hemostasis, such as thrombolytic agents, other anticoagulants, NSAIDs, platelet inhibitors, or dextran may enhance the anticoagulant effect of dalteparin and is not recommended. 5). 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 risk 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 tumour involvement of the brain and other individual risks.
Thrombocytopenia, should it occur, usually appears within three weeks following the beginning of therapy. Therefore, it is recommended that the platelet counts are measured before starting treatment with Fragmin and monitored closely in first three weeks and regularly thereafter during the treatment.
Special caution is necessary in rapidly developing thrombocytopenia and severe thrombocytopenia (<100,000/μl) associated with positive or unknown results of in-vitro tests for anti-platelet antibody in the presence of Fragmin or other low molecular weight (mass) heparins and/or heparin.
Fragmin induces only a moderate prolongation of the APTT and thrombin time. Accordingly, dosage increments based upon prolongation of the APTT may cause overdosage and bleeding. Therefore, prolongation of the APTT should only be used as a test of overdosage.
g. history of confirmed or suspected immunologically mediated heparin induced thrombocytopenia (type II); acute gastroduodenal ulcer; cerebral haemorrhage; known haemorrhagic diathesis or other active haemorrhage; serious coagulation disorders; acute or sub-acute septic endocarditis; haemorrhagic pericardial effusion and haemorrhagic pleural effusion; injuries to and operations on the central nervous system, eyes and ears.
In patients receiving Fragmin for treatment rather than prophylaxis, local and/or regional anaesthesia in elective surgical procedures is contra-indicated with high doses of dalteparin (such as those needed to treat acute deep-vein thrombosis, pulmonary embolism, and unstable coronary artery disease).
In cancer patients with body weight < 40kg 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 data. Dalteparin should not be used in patients who have suffered a recent (within 3 months) stroke unless due to systemic emboli.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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No data is available with dalteparin beyond 6 months of treatment in the CLOT study. In the case of chemotherapy-induced thrombocytopenia, Fragmin dose should be adopted as follows: - With platelet counts <50,000/mm3, Fragmin dosing should be interrupted until the platelet count recovers above 50,000/mm3 - For platelet counts between 50,000 and 100,000/mm3, Fragmin should be reduced as illustrated in the table below depending on the patient’s weight.
Once the platelet count has recovered to ≥100,000/mm3, Fragmin should be re-instituted at full dose. Body Weight (kg) Scheduled Fragmin Dose (IU) Reduced Fragmin Dose (IU) ≤56 7 500 5 000 57 to 68 10 000 7 500 69 to 82 12 500 10 000 83 to 98 15 000 12 500 ≥99 18 000 15 000 Renal failure: In the case of significant renal failure, defined as a creatinine clearance <30 ml/min, the dose of Fragmin should be adjusted based on anti-Factor Xa activity.
If the anti-Factor Xa level is below or above the desired range, the dose of Fragmin should be increased or reduced respectively, and the anti- Factor Xa measurement should be repeated after 3-4 new doses. This dose adjustment should be repeated until the desired anti-Factor Xa level is achieved.
70), respectively, on week 1 and 4 of dalteparin 200 IU/kg OD. Anti-Factor Xa activity determinations were conducted by the chromogenic method. For patients with an increased risk of bleeding, it is recommended that Fragmin be administered according to the twice daily regimen detailed in the Summary of Product Characteristics for Fragmin 10,000 IU/1ml ampoules or Fragmin Multidose Vial.
Paediatric population Treatment of symptomatic venous thromboembolism (VTE) in paediatric patients 1 month of age and older. A concentration of 2,500 IU/ml is recommended to ensure accuracy of dosing for the youngest age cohort. 6). For children under 3 years of age, a presentation without benzyl alcohol should be used.
Treatment of symptomatic venous thromboembolism in paediatric patients The recommended starting dose according to paediatric age is provided in the table below. 0 ml; if it is below/above this range, a less/more concentrated (respectively) solution for administration should be prepared.
0 ml of the solution as supplied and then add diluent (diluent volume is expressed as a multiple of V); administer the correct volume of the diluted solution. For children >20 kg, the 12,500 IU/ml concentration may also be administered directly, without dilution.
** The 10,000 IU/ml (10 ml vial) and 25,000 IU/ml (4 ml vial) multidose vials contain benzyl alcohol. For children under 3 years of age, a presentation without benzyl alcohol should be used. *** […]
Although this has not been observed with dalteparin, the risk of osteoporosis cannot be excluded. Paediatric population Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. The safety of long term dalteparin administration has not been established.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Monitoring Anti-Xa Levels Monitoring of Anti-Xa Levels in patients using Fragmin is not usually required but should be considered for specific patient populations such as paediatrics; those with renal failure, those who are very thin or morbidly obese, pregnant or at increased risk for bleeding or rethrombosis Where monitoring is necessary, laboratory assays using a chromogenic substrate are considered the method of choice for measuring anti-Xa levels.
Activated partial thromboplastin time (APTT) or thrombin time should not be used because these tests are relatively insensitive to the activity of dalteparin. 9). Patients under chronic haemodialysis with dalteparin need as a rule fewer dosage adjustments and as a result fewer controls of anti-Xa levels.
2) Patients with severely disturbed hepatic function, significant renal failure or chemotherapy induced thrombocytopenia may need a reduction in dosage and should be monitored accordingly. If a transmural myocardial infarction occurs in patients where thrombolytic treatment might be appropriate, this does not necessitate discontinuation of treatment with Fragmin but might increase the risk of bleeding.
As individual low molecular weight (mass) heparins have differing characteristics, switching to an alternative low molecular weight heparin should be avoided. The directions for use relating to each specific product must be observed as different dosages may be required.
Interchangeability with other anticoagulants Dalteparin cannot be used interchangeably (unit for unit) with unfractionated heparin, other low molecular weight heparins, or synthetic polysaccharides. Each of these medicines differ in their starting raw materials, manufacturing process, physico-chemical, biological, and clinical properties, leading to differences in biochemical identity, dosing and possibly clinical efficacy and safety.
Each of these medicines is unique and has its own instructions for use. Heparin can suppress adrenal secretion of aldosterone leading to hyperkalaemia, particularly in patients such as those with diabetes mellitus, chronic renal failure, pre- existing metabolic acidosis, a raised plasma potassium or taking potassium sparing drugs.
The risk of hyperkalaemia appears to increase with duration of therapy but is usually reversible. Plasma potassium should be measured in patients at risk before starting heparin therapy and monitored regularly thereafter particularly if treatment is prolonged beyond about 7 days.
When neuraxial anaesthesia (epidural/spinal anaesthesia) or spinal puncture is employed, patients are at risk of developing an epidural or spinal hematoma, which can result in long-term or permanent paralysis. The risk of these events is increased by the use of indwelling epidural catheters or by the concomitant use of drugs affecting hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, or other anticoagulants.
The risk also appears to be increased by traumatic or repeated epidural or spinal puncture. Patients should be monitored frequently for signs and symptoms of neurological impairment when anticoagulation is given in connection with epidural/spinal anaesthesia.
Insertion or removal of the epidural or spinal catheter should be postponed to 10-12 […]