Feiba NF

/ Takeda

The dosage and duration of the therapy depend on the severity of the haemostasis disturbance, the location and extent of the bleeding and on the clinical condition of the patient. The dosage and frequency of administration should always be guided by the clinical efficacy in the individual case. As a general guide a dose of 50 to 100 U per kg body weight (bw) is recommended, however, a single dose of 100 U/kg bw and a maximum daily dose of 200 U/kg bw should not be exceeded. Coagulation tests such as the whole blood clotting time (WBCT), the thromboelastogram (TEG, r-value), and the aPTT usually show only a minor reduction and may not correlate with clinical improvement. Consequently, these tests are only of very limited value in monitoring therapy.
Spontaneous Haemorrhage
Joint, Muscle and Soft Tissue Haemorrhage: For minor to moderate bleedings a dose of 50-75 U/kg bw is recommended at 12-hour intervals. Treatment should be continued until clear signs of clinical improvement appear, such as relief of pain, reduction of swelling or flexibility of the joint. For major muscle and soft tissue haemorrhage, such as retroperitoneal bleeding, a dose of 100 U/kg bw at 12-hour intervals is recommended.
Mucous Membrane Haemorrhage: A dose of 50 U/kg bw is recommended to be given every 6 hours with careful monitoring of the patient (visible bleeding site, repeated measurements of haematocrit). If the haemorrhage does not stop, the dose may be increased to 100 U/kg bw. (Do not exceed the maximum daily dose of 200 U/kg bw.)
Other Severe Haemorrhages: Severe haemorrhages, such as CNS bleedings have been effectively treated with doses of 100 U/kg bw at 12-hour intervals. In individual cases this product may be given at 6-hour intervals until clear clinical improvement is achieved. (Do not exceed the maximum daily dose of 200 U/kg bw.)
Surgery:  50-100 U/kg bw should be given at intervals of up to 6 hours, a maximum daily dose of 200 U/kg bw should not be exceeded.

Control of bleeding episodes in hemophilia A with Factor VIII inhibitions, acquired Factor VIII inhibitions.

FEIBA NF must not be used in case of hypersensitivity to any one of the ingredients. Depending on therapeutic alternatives, the contraindications below are to be considered relative or absolute In the following situations this product should only be used when no reaction to treatment with other appropriate coagulation factor concentrates is to be expected- such as in case of a high inhibitor titre and a life-threatening haemorrhage or risk of bleeding e.g. posttraumatic or postoperative. Disseminated Intravascular Coagulation (DIC): when results of laboratory tests and/or clinical symptoms clearly indicates a liver damage, there is an increased risk of developing DIC due to delayed degradation of activated coagulation factors. Coronary heart disease, acute thrombosis and/or embolism: in patients with a tentative or definite diagnosis of coronary heart disease as well as in patients with acute thrombosis and/or embolism, the use of this product should only be used in life-threatening bleeding episodes.
For full details see prescribing information.

Special Precautions for Use: As in case with all intravenously administered plasma products (protein preparation), allergic reactions may occur. The patients should be informed about possible early signs of intolerance. In rare cases allergic reactions such as reactions from nettle rash, hives, fever, urticarial rashes, feeling of chest tightness, respiratory distress, wheezing, and fall in blood pressure due to allergic shock, nausea and retching as well as other anaphylactoid reactions of varying severity have been observed after administration. If hypersensitivity reactions occur during administration, the injection/infusion should be stopped. Minor reactions may be controlled by antihistamines. In case of shock, the current medical standards for shock treatment are to be observed. In patients with a history of hypersensitivity reactions to plasma derivatives the prophylactic administration of antihistamines may be indicated. Appropriate vaccination should be considered in patients with an inhibitor against a coagulationfactor. As the quantity of sodium in the maximum daily dose may exceed 200 mg, special care should be taken with individuals on a low sodium diet.
Monitoring of Therapy: Single doses of 100 U/kg bw and daily doses of 200 U/kg bw should not be exceeded. Patients given single doses of 100 U/kg bw should be carefully monitored for the development of DIC or symptoms of acute coronary ischaemia. High doses of FEIBA NF should be given only for as long as absolutely necessary to stop the bleeding.
Disseminated Intravascular Coagulation (DIC): In case of significant clinical changes in blood pressure, pulse rate, respiratory distress, chest pain and cough, the infusion should be stopped promptly and appropriate diagnostic and therapeutic measures are to be initiated. Laboratory results indicative of DIC are decreased fibrinogen values, decreased platelet count, and/or presence of fibrin/fibrinogen degradation products (FDP). Other parameters of DIC include significantly prolonged thrombin time, prothrombin time, or aPTT. If coagulation parameters are suspicious of DIC, a physician experienced in coagulation therapies should be consulted. There is insufficient data in children under 6 years of age to recommend the use of this product. However, inhibitor formation is a common occurrence in haemophilic children undergoing factor VIII replacement therapy. Case studies have shown the successful use in the young age group.
FEIBA NF 500 U and FEIBA NF 1000 U contain approx. 80 mg sodium (calculated) per vial. This has to be attended for patients on low sodium diet.
For full details see prescribing information.

Rapid intravenous injection or infusion may cause stabbing pain and numbness in the face and extremities as well as a drop in blood pressure. Following adverse reactions have been reported during post marketing. The frequency cannot be estimated due to the nature of the data and therefore is categorized as unknown.
For full details see prescribing information.

It is not recommended to use antifibrinolytics such as epsilon-aminocaproic acid in combination with this product. If treatment with both antifibrinolytics such as epsilon-aminocaproic acid andthis product is indicated, the products should be administered at least 6 hours apart.
For full details see prescribing information.

Animal reproduction studies have not been conducted with this product based on the rare occurrence of haemophilia in women. Experience regarding the use of this product during pregnancy and breast feeding is not available. Therefore, due to the increased risk of thrombosis during pregnancy, this product should only be used under careful medical monitoring and if no alternative therapy is available.

Overdose may increase the risk of side effects such as thromboembolism, DIC or myocardial infarction.