Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated is indicated for the control of spontaneous bleeding episodes or to cover surgical interventions in hemophilia A and B patients with inhibitors.

In addition, the use of Anti-Inhibitor Coagulant Complex, Feiba Immuno has been described in a few non-hemophiliacs with acquired inhibitors to Factors VIII,XI, and XII^8-12.One case has been reported where Anti-Inhibitor Coagulant Complex, Feiba Immuno 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 Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated. 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 = Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated

AHF = Antihemophilic Factor

Patients Inhibitor Titer	Clinical Situation
	Minor Bleeding	Major Bleeding	Surgery (Emergency)
less than 5 B.U.	AHF	AHF	AHF
5 to 10 B.U.	AHF	AHF	AHF
	AICC	AICC	AICC
more than 10 B.U.	AICC	AICC	AICC

 

Inadequate response to treatment may result from an abnormal platelet count or impaired platelet function^13-15 which were present before treatment with Anti-Inhibitor Coagulant Complex,Feiba VH,Vapor Heated.

(See under "For Intravenous Injection or Infusion").

Clinical trials 5-7 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:

Joint Hemorrhage

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, Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated may be indicated at 6-hour intervals until clear clinical improvement is achieved.

Reconstitution 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. 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: 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.

EIBA VH Anti-Inhibitor Coagulant Complex, Vapor Heated is supplied as freeze-dried powder accompanied by a suitable volume of Sterile Water for Injection U.S.P., one BAXJECT Needle-less Transfer device, Package insert.

The number of Units of Factor VIII inhibitor bypassing activity is stated on the label of each vial. Certain components of the packaging material contain Dry Natural Rubber Latex.

STORAGE

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.

REFERENCES

1. ELSINGER F.:Aktivierter Faktor VII in Prothrombinkomplex-Konzentraten.23rd Annual Meeting of "Deutsche Arbeitsgemeinschaft für Blutgerinnungsforschung" (DAB),Heidelberg,1979.F.K.Schattauer Verlag, Stuttgart-New York,367,1980.

2. SELIGSOHN U., ØSTERUD B.,RAPAPORT S.I.: Coupled Amidolytic Assay for Factor VII: Its Use With a Clotting Assay to Determine the Activity State of Factor VII. Blood 52:978,1978.

3. SELIGSOHN U.,KASPER C.K., ØSTERUD B.,RAPAPORT S.I.: Activated Factor VII: Presence in Factor IX Concentrates and Persistence in the Circulation After Infusion. Blood 53:828,1979.

4. MANNUCCI P.M.: Personal communication

5. SJAMSOEDIN L.J.M.,HEIJNEN L.,MAUSER-BUNSCHOTEN E.P., van GEIJLSWIJK J.L., van HOUWELIN-GEN 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-By-Passing-Activity (FEIBA IMMUNO) Product for Treatment of Bleeding Episodes in Hemophiliacs with Inhibitors. Blood 61:36,1983.

8. THOMAS T.,WILLIAMS H.,WILLIAMS Y.,HUNT J.:FEIBA in Haemophiliacs with Factor VIII Inhibitor.Brit.Med.J.1:52,1977.

9. ROLOVIC Z.,ELEZOVIC I.,OBRENOVIC 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.,SCHETZ 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 F VIII. Presentation at the Second Workshop on Factor VIII Inhibitor Patients,Vienna,1979.

16. HILGARTNER M.W.: Personal communication.

To enroll the confidential, Industry-wide Patient Notification System, call 1-888-UPDATE (1-888-873-2838) Feiba, Prothromplex and Immuno are trademarks of Baxter AG,Austria. Hyland and Baxter are trademarks of Baxter International, Inc., USA