Fragmin® Tolerability

Fragmin Tolerability

Fragmin® has been extensively used since its launch in 19921

Approximately 3% of the patients receiving prophylactic treatment reported side effects2-7. Fragmin® is an antithrombotic agent that acts mainly through its ability to potentiate the inhibition of Factor Xa and thrombin by antithrombin. Compared with standard, unfractionated heparin, Fragmin® has a reduced adverse effect on platelet function and platelet adhesion, and thus only has a minimal effect on primary haemostasis2-7.

Please refer to the SPC for a list of adverse events which may possibly be associated with Fragmin®.

The risk of bleeding is dependent 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. Rarely, clinically significant hyperkalaemia may occur particularly in patients with chronic renal failure and diabetes mellitus.

Long term treatment with heparain has been associated with a risk of osteoporosis. 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 established2-7.

References

1. Data on file (IMS Data).
2. Fragmin SmPC [Surgical Thromboprophylaxis (2,500 IU and 5,000 IU syringes)]. Available at: https://www.medicines.org.uk/emc/product/4246 and https://www.medicines.org.uk/emc/product/4247
3. Fragmin SmPC [Medical Thromboprophylaxis (5,000 IU syringes)]. Available at: https://www.medicines.org.uk/emc/product/4247
4. Fragmin SmPC [Treatment of VTE (7,500-18,000 IU syringes, 10,000 IU/1 ml ampoules, 100,000 IU/4 ml Multidose Vial)]. Available at: https://www.medicines.org.uk/emc/search?q=fragmin
5. Fragmin SmPC [Unstable Angina (Graduated syringe 10,000 IU/ml solution for injection, 10,000 IU/1 ml ampoule, 7,500 IU)]. Available at: https://www.medicines.org.uk/emc/search?q=fragmin
6. Fragmin SmPC [Haemodialysis/Haemofiltration (10,000 IU/1 ml & 10,000 IU/4 ml ampoules)]. Available at: https://www.medicines.org.uk/emc/product/4251 and https://www.medicines.org.uk/emc/product/4244
7. Fragmin SmPC [Extended Treatment in Oncology (5,000-18,000 IU syringes)]. Available at: https://www.medicines.org.uk/emc/search?q=fragmin

*Including, but not limited to: congestive cardiac failure (NYHA class III or IV), acute respiratory failure or acute infection, who also have a predisposing risk factor for VTE such as age over 75 years, obesity, cancer or previous history of VTE.~
†In patients with chronic renal insufficiency or acute renal failure.

PP-FRA-GBR-0169.  June 2019