Prothrombinex Dosing
Suggested dose of Prothrombinex-VF to reverse Warfarin according to the initial
and target INR
Prothrombinex-VF is available in 500iu vials.
|
Initial INR |
|||
Target INR |
1.5 – 2.5 |
2.6 – 3.5 |
3.6 – 10.0 |
>10.0 |
0.9 – 1.3 |
30 IU/kg |
35 IU/kg |
50 IU/kg |
50 IU/kg |
1.4 – 2.0 |
15 IU/kg |
25 IU/kg |
30 IU/kg |
40 IU/kg |
CONTRAINDICATIONS
Hypersensitivity to the active substances or to any of the excipients including known allergy to heparin or history of heparin-induced thrombocytopenia (HIT). Prothrombinex®-VF is also contraindicated in patients who have evidence of active thrombosis or disseminated intravascular coagulation (DIC).
PRECAUTIONS
Specialist advice is recommended in the management of patients receiving PCCs. Patients receiving a vitamin K antagonist (such as warfarin and phenindione) may have an underlying hypercoagulable state and infusion of human prothrombin complex may exacerbate this. Prothrombinex®-VF should be used with caution in patients with a known allergy to constituents of the preparation. In case of anaphylactoid reaction, administration should be stopped immediately. In patients with acquired deficiency of the vitamin K dependent coagulation factors (e.g. as induced by treatment with vitamin K antagonists), Prothrombinex®-VF should only be used when rapid correction of the prothrombin complex levels is necessary. In other cases, reduction of the dose of the vitamin K antagonist or omission of the next dose and/or administration of vitamin K is usually sufficient.
There is a risk of thrombosis, DIC or myocardial infarction when patients, with either congenital or acquired deficiency are treated with PCCs. This risk may be increased with repeated or high doses (especially at dose levels greater than 50 IU/kg of factor IX). Patients given human prothrombin complex should be observed closely for signs or symptoms of intravascular coagulation, thrombosis, embolism and myocardial infarction. Because of the risk of thromboembolic complications, close monitoring should be exercised when administering PCC to patients with a history of coronary heart disease, to patients with liver disease, to peri- or post-operative patients or to patients at risk of thromboembolic events or DIC. In each of these situations, the potential benefit of treatment should be weighed against the risk of these complications.
Prothrombinex®-VF contains heparin sodium which may cause heparin-induced thrombocytopenia (HIT). The possibility of HIT developing during treatment should be considered if high doses of Prothrombinex®-VF are required