Posology : מינונים

4.2. Posology and method of administration

The treatment is to be initiated and monitored by a physician experienced in the management of coagulation disorders.

Posology
Dosage and duration of the treatment depend on the severity of the haemostatic disorder, the localization and the extent of the bleeding, as well as the clinical condition of the patient.

Dosage and frequency of administration should always be guided by the clinical efficacy in each individual case.

As a general guideline a dose of 50 - 100 U of FEIBA per kg body weight is recommended; a single dose of 100 U/kg body weight and a maximum daily dose of 200 U/kg body weight must not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses. See section 4.4.

Paediatric use (children)
The experience in children under 6 years of age is limited; the same dose regimen as in adults should be adapted to the child’s clinical condition.

1) Spontaneous bleeding
Joint, muscle and soft tissue hemorrhage
A dose of 50 - 75 U/kg body weight at 12-hour intervals is recommended for minor to moderately severe bleeding. The treatment is to be continued until a clear improvement of the clinical symptoms, e.g.
reduction of pain, decrease of swelling or increase of joint mobility, occurs.

For severe muscle and soft tissue bleeding, e.g., retroperitoneal hemorrhages, a dose of 100 U/kg body weight at 12-hour intervals is recommended.

Mucous membrane hemorrhage
A dose of 50 U/kg body weight every 6 hours under careful monitoring of the patient (visual control of bleeding, repeated determination of hematocrit) is recommended. If the bleeding does not stop, the dose may be increased to 100 U/kg body weight, however a daily dose of 200 U/kg body weight must not be exceeded.

Other severe hemorrhages
In severe hemorrhage, such as CNS bleeding, a dose of 100 U/kg body weight at 12-hour intervals is recommended. In individual cases, FEIBA may be administered at 6-hour intervals, until clear improvement of the clinical condition is achieved. (The maximum daily dose of 200 U/kg body weight must not be exceeded!)

2) Surgery
In surgical interventions, an initial dose of 100 U/kg body weight may be administered preoperatively, and a further dose of 50 – 100 U/kg body weight may be administered after 6 – 12 hours. As a postoperative maintenance dose, 50 – 100 U/kg body weight may be administered at 6 – 12-hour intervals; dosage, dosage intervals and duration of the peri- and postoperative therapy are guided by the surgical intervention, the patient’s general condition and the clinical efficacy in each individual case. (The maximum daily dose of 200 U/kg body weight must not be exceeded!)

3) Use of FEIBA in special patient groups
See section 5.1 for information in relation to hemophilia B patients with factor IX inhibitor.

In combination with factor VIII concentrate, FEIBA was also used for long term therapy to achieve complete and permanent elimination of the factor VIII inhibitor.

Monitoring
In case of inadequate response to treatment with the product, it is recommended that a platelet count be performed because a sufficient number of functionally intact platelets is considered to be necessary for the efficacy of the product.


Due to the complex mechanism of action, no direct monitoring of active ingredients is available.
Coagulation tests such as the whole blood coagulation time (WBCT), the thromboelastogram (TEG, r- value) and the aPTT usually show only little reduction and do not necessarily correlate with the clinical efficacy. Therefore these tests have little significance in the monitoring of the therapy with FEIBA. See section 4.4.

Method of administration

Reconstitute the product as described in section 6.6 and administer slow infusion via the intravenous route. An infusion rate of 2 U/kg body weight per minute must not be exceeded.