Treatment of Venous Thromboembolism (VTE): Dosing

Dosing

Use of Fragmin® for the treatment of VTE1

Indication:

Treatment of venous thromboembolism (VTE) presenting clinically as deep vein thrombosis (DVT), pulmonary embolism (PE) or both1

Dosage:

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):1

Prefilled Syringes:

Prefilled Syringes Table

The single daily subcutaneous dosage should not exceed 18,000 IU

In case of overdose the recommneded dosage of protamine is 1mg of protamine/100 IU Fragmin®

Ampoules:

Fragmin Ampoules Dosing** The single daily dose should not exceed 18,000 IU.
≈ Monitoring of the treatment is generally not necessary but can be performed with a functional anti-Factor Xa assay. Maximum plasma levels are obtained 3–4 hours after sc. injection, when samples should be taken. Recommended plasma levels are between 0.5–1.0 IU (anti-Factor Xa)/ml.

 Simultaneous anticoagulation with oral VKAs (vitamin K antagonists) can start immediately1

Treatment with Fragmin® is continued until the prothrombin complex levels (Factor II, VII, IX, X) have decreased to a therapeutic level1

At least 5 days of combined treatment is normally required1

References

1. 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

*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-0158.  June 2019