BEBULIN is indicated for the prevention and control of
bleeding episodes in adult patients with hemophilia B (congenital Factor IX
deficiency or Christmas disease).
BEBULIN is not indicated for use in the treatment of
Factor VII deficiency. No clinical studies have been conducted to show benefit
from this product for treating deficiencies other than Factor IX deficiency.
DOSAGE AND ADMINISTRATION
For intravenous administration only
One International Unit (IU) of Factor IX activity/kg will
increase the plasma level of Factor IX by 0.8%. Accordingly, the following
formula is provided for dosage calculations:
Number of Factor IX IU required = bodyweight (kg) x
desired Factor IX increase (% of normal) x 1.2.
The response to treatment will vary from patient to
patient. Exact dosage determination should be based on localization and extent
of hemorrhage, and the level of Factor IX to be achieved. Close laboratory
monitoring of the Factor IX level is required to determine proper dosage, particularly
with severe hemorrhage and major surgery. Larger doses than those derived from
the above formula may be required, particularly if treatment is delayed.
Management Of Bleeding7-11
Approximate desired Factor IX levels, typical initial
doses, and the average duration of treatment are suggested in Table 3. For
minor bleeding, a single dose will usually be sufficient; otherwise a second
dose may be given after 24 hours. More severe hemorrhage will require several
doses at approximately 24-hour intervals. For maintenance therapy, usually two
thirds of the initial dose is infused.
Table 3. Management of Specific Types of Bleeding
|Type of Bleeding
||Approximate Desired Factor IX Level (% Normal)
||Typical Initial Dose (International Units/kg)
||Average Duration of Treatment (Days)
|Minor Early hemarthrosis, minor epistaxis, and gingival bleeding, mild hematuria
|Moderate Severe joint bleeding, early hematoma, major open bleeding, minor trauma, minor hemoptysis, hematemesis, melena, and major hematuria
||2 or until adequate wound healing
|Major Severe hematoma, major trauma, severe hemoptysis, hematemesis, and melena
|| > 60*
||2-3 or until adequate wound healing
|* For patients predisposing to thrombosis see PRECAUTIONS section.
Management Of Surgical Procedures 7-11
Dosage guidelines for surgical procedures are suggested
in Table 4. Administer preoperative loading dose one hour prior to surgery.
Depending on the type of surgery, continue replacement therapy over one to
several weeks until adequate wound healing is achieved. The average treatment
interval will initially be 12 hours, while in the later postoperative period,
24 hours is adequate.
Table 4: Management of Surgical Procedures
|Type of Surgery
||Day of Operation
||Init. Postop. Period (1st to 2nd Week)
||Late Postop. Period (from 3rd Week Onwards)
|Approx. Level Factor IX (% Normal)
||Approx. Level Factor IX (% Normal)
||Approx. Level Factor IX (% Normal)
|| ≥ 60*
|* For patients predisposing to thrombosis see PRECAUTIONS section. N/A: Not Applicable.
For tooth extraction, the same initial dose as for minor
surgery is recommended and one infusion should be sufficient. In case of
extraction of several teeth, replacement therapy for up to one week may be
necessary using the same doses as for minor surgery.8-11
- Do not mix BEBULIN with other medicinal products or
solvents, other than the enclosed sterilized water for injection.
- Administer BEBULIN within 3 hours after reconstitution as
the solution does not contain a preservative. Do not refrigerate after
- Warm unopened vials of both diluent and concentrate to
room temperature (not to exceed 37°C, 98°F).
- Remove caps from both vials to expose central portions of
the rubber stoppers.
- Cleanse exposed surface of the rubber stoppers with
germicidal solution and allow to dry.
- Using aseptic technique, remove protective covering from
one end of the double-ended needle and insert the exposed end through the
diluent vial stopper.
- Remove protective covering from the other end of the
double-ended needle. Do not touch the exposed end. Invert diluent vial over the
concentrate vial, then insert free end of the needle through the concentrate
vial stopper. Diluent will be drawn into the concentrate vial by vacuum.
- Disconnect the two vials by removing needle from the
concentrate vial stopper. Gently agitate or rotate the concentrate vial until
all material is dissolved.
For Intravenous Administration Only.
- Parenteral drug products should be inspected for
particulate matter and discoloration prior to administration.
- The reconstituted product should be colorless to slightly
yellowish and clear to slightly turbid solution. Do not administer if
particulate matter or discoloration is found and notify Baxter immediately.
- Record the name of the patient and batch number of the
product in order to maintain a link between the patient and the batch of the
- After reconstituting the concentrate as described above,
attach the enclosed filter needle to a sterile disposable syringe using aseptic
technique. Insert filter needle through the concentrate vial stopper.
- Inject air and withdraw solution into the syringe.
- Remove and discard filter needle. Attach a suitable
intravenous needle or infusion set with winged adapter.
- Administer the solution intravenously at a rate
comfortable to the patient. The infusion rate should not exceed 2 mL per
BEBULIN is supplied in single dose vials (NDC
64193-445-02) with Sterile Water for Injection, U.S.P., double-ended needle,
and filter needle for reconstitution and withdrawal. Factor IX activity in
international units is stated on the label of each vial.
Store at refrigerated temperature (2°C-8°C, 35°F-46°F).
Do not use BEBULIN past the expiration date printed on the unit carton. Do not
To enroll in the confidential, Industry-wide Patient
Notification System, call 1-888-873-2838.
7. P. H. Levine: Clinical Manifestations and Therapy of
Hemophilias A and B. In: R. W. Colman, J. Hirsh, V. J. Marder, E. W. Salzman
(Eds.): Hemostasis and Thrombosis. Philadelphia: J. B. Lippincott Company,
1987, pp. 97-111.5.
8. C. R. Rizza, P. Jones: Management of patients with
inherited blood coagulation defects. In: A.L. Bloom, D.P. Thomas (Eds.):
Hemostasis and Thrombosis. Edinburgh: Churchill Livingstone, 1987, pp. 465-493.
9. T. Abe, M. Kazama: An International Survey on the
Appropriate Dosage of Hemophilias and Related Congenital Coagulopathies. In:
Proceedings of the 3rd International Symposium on Haemostasis and Thrombosis,
1982, pp. 273-304.
10. I. M. Nilsson, Ã
. Ahlberg, G. Björlin: Clinical
Experience with a Swedish Factor IX Concentrate. Acta Med. Scand., 190, 1971,
11. J. N. George, R. T. Breckenridge: The Use of Factor
VIII and Factor IX Concentrates During Surgery. JAMA, 214, 1970, 9, pp.
Baxter Healthcare Corporation Westlake Village, CA 91362 USA. Revised: / July 2012