Bebulin

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 Bleeding 7-11

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-hours intervals. For maintenance therapy, usually two thirds of the initial dose is infused.

Table 3 Management of Specific Types of Bleeding * For patients predisposing to thrombosis see Precautions section. Type of Bleeding

ApproximateDesired Factor IX Level

(% Normal)

Typical InitialDose

(International Units/kg)

Average Durationof Treatment

(Days)

Minor
Early hemarthrosis,
minor epistaxis,

and gingival bleeding, mild hematuria 20 25-35 1

Moderate
Severe joint bleeding,
early hematoma, major open bleeding, minor trauma, minor hemoptysis,

hematemesis,
and melena,
major hematuria 40 50-65

2 or until adequate

wound healing

Major
Severe hematoma major trauma, Severe hemoptysis,

hematemesis, and
melena ≥60* 75-90

2-3 or until adequate

wound healing 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 * N/A– Not Applicable. † For patients predisposing to thrombosis see Precautions section.

Type ofSurgery

Day of Operation

Init. Postop. Period

(1st to 2nd Week)

Late Postop. Period(from 3rd Week Onwards)

Approx. Level Factor IX

(% Normal)

Dose

(IU/kg)

Approx. Level Factor IX

(% Normal)

Dose

(IU/kg)

Approx. Level Factor IX

(% Normal)

Dose

(IU/kg)
Minor 40-60 50-75

20-40

25-65

N/A* N/A* Major

≥60†

75-90 20-60 25-75 20 25-35

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 surgery8-11.

Reconstitution 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 reconstitution. 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. Administration

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 product. 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 minute.