Feiba Dosage/Direction for Use

Dosage: Treatment should be initiated and supervised by a physician experienced in the management of hemophilia.
The dosage and duration of the therapy depend on the severity of the disorder of haemostasis, on the location and extent of the bleeding and on the clinical condition of the patient.
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 of FEIBA per kg body weight (bw) is recommended, however, a single dose of 100 U/kg body weight and a daily dose of 200 U/kg body weight should not be exceeded unless the severity of bleeding warrants and justifies the use of higher doses. See Precautions.
Coagulation tests such as the whole blood clotting time (WBCT), the thromboelastogramme (TEG, r-value), and the aPTT usually show only a minor shortening and may not correlate with clinical improvement. Consequently, these tests are only of very limited value in monitoring FEIBA 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 mobilization of the joint.
For major muscle and soft tissue haemorrhage, such as retro peritoneal 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 hour 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 FEIBA 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.)
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 post-operative 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 post-operative 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.)
In high responder patients with a history of frequent bleeding, FEIBA can be given concomitant to F VIII concentrate in a dose range of 50 to 100 U/kg bw twice a day until the reduction of the factor VIII inhibitor to 1 B.U.*
*1 Bethesda Unit is defined as that amount of antibody that will inhibit 50% of the F VIII activity off fresh average human plasma after incubation for 2 hours at 37°C.
Prophylaxis of bleeding in patients with a high inhibitor titre and frequent haemorrhages after failed immune tolerance induction (ITI) or when an ITI is not considered: A dose of 70-100 U/kg body weight every other day is recommended. If necessary, the dose may be increased to 100 U/kg body weight per day or it may be decreased gradually.
Administration: Reconstitute the product as described under Instructions for Use/Handling/Disposal under Cautions for Usage and inject or infuse slowly by the intravenous route. Do not exceed an injection/infusion rate of 2 U/kg bw per minute.
FEIBA must be administered as an intravenous injection or infusion. The rate of administration should ensure the comfort of the patient and should not exceed a maximum of 2 U/kg body weight per minute.
It is recommended that every time FEIBA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
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 are 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 whole blood clotting time (WBCT) and the aPTT may not correlate with clinical improvement.