DOSAGE AND ADMINISTRATION
(See under intravenous Injection/Infusion).
Clinical trials5-7 have demonstrated that the response to treatment with FEIBA IMMUNO AICC may differ from patient to patient with no correlation to the patient's inhibitor titer. Response may also vary between different types of hemorrhage (e.g. joint hemorrhage vs. CNS hemorrhage).
As a general guideline, a dosage range of 50 to 100 Units of FEIBA VH AICC per kg of body weight is recommended. However, care should be taken to distinguish between the following four indications, all of which have undergone careful clinical evaluation:
In joint hemorrhage, a dose of 50 units per kg of body weight is recommended at 12-hour intervals, which may be increased to doses of 100 units per kg of body weight 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.
MUCOUS MEMBRANE BLEEDING
A dose of 50 units per kg of body weight is recommended to be given at 6-hour intervals under careful monitoring (visible bleeding site, repeated measurements of the patient's hematocrit). Again, if hemorrhage does not stop, the dose may be increased to 100 units per kg of body weight at 6-hour intervals. However, 2 such administrations or 200 units per kg of body weight a day should not be exceeded.
SOFT TISSUE HEMORRHAGE
For serious soft tissue bleeding such as retroperitoneal bleeding, doses of 100 units per kg of body weight at 12-hour intervals are recommended. A daily dosage of 200 units per kg of body weight should not be exceeded.
OTHER SEVERE HEMORRHAGES
Severe hemorrhages, such as CNS bleedings have been effectively treated with doses of 100 units per kg of body weight at 12-hour intervals. Sometimes, FEIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated may be indicated at 6-hour intervals until clear clinical improvement is achieved.
Warm the unopened vial containing Sterile Water for Injection (diluent) to room temperature (not above 37°C, 98°F).
Remove caps from the concentrate and diluent vials to expose central portions of the rubber stoppers.
Cleanse exposed surface of the rubber stoppers with germicidal solution and allow to dry.
Open the package of BAXJECT device by peeling away the lid without touching the inside (Fig a).
- Do not remove the device from the package. Turn the package over and insert the plastic spike through diluent stopper (Fig. b).
Grip the package at its edge and pull the package off the device (Fig.b).
Turn the system over,so that the bottle is on top. Quickly insert the other plastic spike into the FEIBA VH AICC stopper (Fig.c). The vacuum will draw the diluent into the FEIBA VH AICC vial.
Swirl gently until FEIBA VH AICC is completely dissolved.
Do not refrigerate after reconstitution!
After complete reconstitution of FEIBA VH AICC, its injection or infusion should be commenced as promptly as practicable, but must be completed within three hours following reconstitution.
The solution must be given by intravenous injection or intravenous drip infusion and the maximum injection or infusion rate must not exceed 2 units per kg of body weight per minute. In a patient with a body weight of 75 kg, this corresponds to an infusion rate of 2.5 - 7.5 mL per minute depending on the number of units per vial (see label on vial).
FOR INTRAVENOUS INJECTION OR INFUSION
After reconstituting the concentrate as described under Reconstitution, parenteral drug products should be inspected for particulate matter and discoloration prior to administration, whenever solution and container permit. Plastic luer lock syringes are recommended for use with this product since protein such as FEIBA VH AICC tends to stick to the surface of all-glass syringes.
Turn the BAXJECT device handle down towards the FEIBA VH AICC concentrate vial and remove the cap attached to the syringe connection of the BAXJECT device (Fig. d).
Draw air into the syringe, connect the syringe to the BAXJECT device, inject air into the concentrate vial (Fig e).
While keeping the syringe plunger in place, turn the system upside down (concentrate vial now on top). Draw the concentrate into the syringe by pulling the plunger back slowly (Fig. f).
Turn the BAXJECT handle to its original position (facing sideways).
Disconnect the syringe, attach a suitable needle and inject or infuse intravenously as instructed under Rate of Administration.