"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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In addition, the use of FEIBA IMMUNO (AICC) has been described in a few non-hemophiliacs with acquired inhibitors to Factors VIII, XI, and XII8–12. One case has been reported where FEIBA IMMUNO (AICC) was effective in a patient with von Willebrand's disease with an inhibitor16.
Clinical experience suggests that patients with a Factor VIII inhibitor titer of less than 5 B.U. may be successfully treated with Antihemophilic Factor. Patients with titers ranging between 5 and 10 B.U. may either be treated with Antihemophilic Factor or FEIBA VH (AICC). Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally been refractory to treatment with Antihemophilic Factor.
Guidelines to First and Second Choice Treatment:
(AICC) = FEIBA VH (anti-inhibitor coagulant complex, vapor heated ) Anti-Inhibitor Coagulant Complex, Vapor Heated
AHF = Antihemophilic Factor
|Patient's Inhibitor||Clinical Situation|
|Titer||Minor Bleeding||Major Bleeding||Surgery (Emergency)|
|less than 5 B.U.||AHF||AHF||AHF|
|5 to 10 B.U.||AHF||AHF||AHF|
|more than 10 B.U.||AICC||AICC||AICC|
Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function13–15 which were present before treatment with FEIBA VH (AICC), Vapor Heated.
DOSAGE AND ADMINISTRATION
(See under "For Intravenous Injection or 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). If hemorrhage does not stop, the dose may be increased to 100 units per kg of body weight at 6-hour intervals. Two 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 (AICC), 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 371C, 981F).
- 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. Please make sure that the connection of the two vials should be done expeditiously to close the open fluid pathway created by the first insertion of the spike to the diluent 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.
Rate of administration
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 sideway).
- Disconnect the syringe, attach a suitable needle and inject or infuse intravenously as instructed under Rate of Administration.
FEIBA VH (AICC), Vapor Heated, is available in single-dose vials in the following nominal potencies:
500 Units (M) per vial (NDC 64193-222-03)
1000 Units (H) per vial (NDC 64193-222-04)
2500 Units (SH) per vial (NDC 64193-222-05)
FEIBA VH (AICC), Vapor Heated, is packaged with a suitable volume (20 mL or 50 mL) of Sterile Water for Injection, U.S.P., one BAXJECT Needleless Transfer Device, and one Package Insert.
Certain components of the packaging material contain Dry Natural Rubber Latex.
The number of Units of Factor VIII inhibitor bypassing activity is stated on the label of each vial.
Store at refrigerated temperature (2° to 8°C, 35° to 46°F).
Within the indicated shelf life, the product may be stored at room temperature (not exceeding 25°C, 77°F) for up to 6 months. After storage at room temperature, the product must not be returned to the refrigerator.
Please note: If you transfer the product from the refrigerator to room temperature, it expires at the end of the 6 months period or at the end of shelf life, whatever comes earlier.
Record the date on the package prior to shifting the product at room temperature.
Avoid freezing, which may damage the diluent vial.
To enroll in the confidential, Industry-wide Patient Notification System, call 1-888-UPDATE U (1-888-873-2838).
5. Sjamsoedin L. J. M., Heijnen L., Mauser-Bunschoten E. P., van Geijlswijk J. L., van Houwelingen H., van Asten P., Sixma J. J.: The Effect of Activated Prothrombin-Complex Concentrate (FEIBA) on Joint and Muscle Bleeding in Patients with Hemophilia A and Antibodies to Factor VIII. The New Engl. J. of Med. 305: 717, 1981.
6. Roberts H. R.: Hemophiliacs with Inhibitors: Therapeutic Options. The New Engl. J. of Med. 305:757, 1981.
7. Hilgartner M. W., Knatterud G. AND THE FEIBA STUDY GROUP: The Use of Factor-Eight-Inhibitor-ByPassing-Activity (FEIBA IMMUNO) Product for Treatment of Bleeding Episodes in Hemophiliacs with Inhibitors. Blood 61: 36, 1983.
8. Thomas T., William. H., Williams Y., Hunt J.: FEIBA in Haemophiliacs with Factor VIII Inhibitor. Brit. Med. J. 1: 52, 1977.
9. Rolovic Z., Elezovic I., Oobrrenovic B.: Life-Threatening Bleeding Due to an Acquired Inhibitor to Factor XII–XI Successfully Treated with FEIBA. Proceedings of Joint Meeting of the 18th Congress of the International Society of Hematology and 16th Congress of the International Society of Blood Transfusion, Montreal. Abstract 703, 1980.
10. Dormandy K.: Unpublished data. 11. Vinazzer H.: Personal communication.
12. Preston F. E.: A Review of Cases Treated with FEIBA in 1977/78. Presentation at the Second Workshop on Factor VIII Inhibitor Patients, Vienna, 1979.
13. Vermylen J., Sschetz J., Semeraro N., Mertens F., Verstraete M.: Evidence that ‘Activated' Prothrombin Concentrates Enhance Platelet Coagulant Activity. Brit. J. Haematol. 38: 235, 1978.
14. Semeraro N., Vermylen J.: Evidence that Washed Human Platelets Possess Factor-X Activator Activity. Brit. J. Haematol. 36: 107, 1977.
15. Wensley R. T.: General Summary of the Use of FEIBA in Haemophiliacs with Inhibitors to FVIII. Presentation at the Second Workshop on Factor VIII Inhibitor Patients, Vienna, 1979.
16. Hilgartner M. W.: Personal communication.
Baxter Healthcare Corporation, Westlake Village, CA 91362, USA. Revised April/2005. FDA Rev date: n/a
Last reviewed on RxList: 10/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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