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Proplex-T

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Proplex-T

Proplex-T

INDICATIONS

PROPLEX T, Factor IX Complex, Heat Treated is indicated for:

  1. Factor IX deficiency (Hemophilia B, Christmas disease). The intravenous administration of PROPLEX T, Factor IX Complex, Heat Treated is intended to prevent or control bleeding episodes in patients with this deficiency. Factor IX Complex should not be used in patients with mild Factor IX deficiency for whom fresh frozen plasma is effective.
  2. Bleeding episodes in patients with inhibitors to Factor VIII. Lusher, et al, have described the use of PROPLEX T, Factor IX Complex, Heat Treated in hemarthroses occurring in hemophiliacs with inhibitors to Factor VIII.12
  3. Factor VII deficiency. The Factor VII content present in PROPLEX T, Factor IX Complex, Heat Treated has been shown to be effective in prevention or control of bleeding episodes in patients with Factor VII deficiency.13

DOSAGE AND ADMINISTRATION

Each bottle of PROPLEX T, Factor IX Complex, Heat Treated is labeled with both the Factor IX and Factor VII content. The Factor IX content is expressed in International Units per bottle and is traceable to the World Health Organization International Standard through a secondary concentrate standard. The Factor VII content is expressed in units per bottle and is traceable to pooled normal plasma through a secondary standard.

The amount of PROPLEX T, Factor IX Complex, Heat Treated required to restore normal hemostasis varies with the circumstances and with the patient. Dosage depends on the degree of deficiency and the desired hemostatic level of the deficient factor. As a guide to calculation of dosage, experience indicates that the following formulas may be used:4,19

Factor IX Deficiency

Units required to raise blood level percentages:

1.0 unit/kg x body weight (in kg) x desired increase (% of normal)

If a 70 kg (154 lb) patient with a Factor IX level of 0% needs to be elevated to 25%, give 1.0 unit/kg x 70 kg x 25 = 1750 units

In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40% to 60% of normal. (See PRECAUTIONS.)

The preceding dosage formula for Factor IX deficiency is presented as a reference and a guideline. Exact dosage determinations should be made based on the medical judgment of the physician regarding circumstances, condition of patient, degree of deficiency, and the desired level of Factor IX to be achieved. If an inhibitor to Factor IX is present, sufficient additional dosage to overcome the inhibitor would be needed. For maintenance of an elevated level of the deficient factor, dosage may be repeated as often as needed. Clinical studies suggest that relatively high levels may be maintained by daily or twice-daily doses, while the lower effective levels may require injections only once every two or three days. A single dose may be sufficient to stop a minor bleeding episode.20,21

Factor VIII Inhibitor

In using Factor IX Complex in the treatment of hemarthroses occurring in hemophiliacs with inhibitors to Factor VIII, dosage levels approximating 75 Factor IX units per kg of body weight have been employed successfully.12

AUTOPLEX T, Anti-Inhibitor Coagulant Complex, is recommended when hemarthroses occurring in hemophiliacs with inhibitors to Factor VIII cannot be resolved by administration of Factor IX complex, and in other types of bleeding episodes in Factor VIII-inhibitor patients.

Factor VII Deficiency

Units required to raise blood level percentages:

0.5 unit/kg x body weight (in kg) x desired increase (% of normal)

Repeat dose every 4 to 6 hours as needed.

If a 70 kg (154 lb) patient with a Factor VII level of 0% needs to be elevated to 25%, give 0.5 unit/kg x 70 kg x 25 = 875 units.

In preparation for and following surgery, levels above 25%, maintained for at least a week after surgery, are suggested. Laboratory control to assure such levels is recommended. To maintain levels above 25% for a reasonable time, each dose should be calculated to raise the level to 40 to 60% of normal. (See PRECAUTIONS).

The preceding dosage formula for Factor VII deficiency is presented as a reference and a guideline. Exact dosage determinations should be made based on the medical judgment of the physician regarding circumstances, condition of patient, degree of deficiency, and the desired level of Factor VII to be achieved. If an inhibitor to Factor VII is present, sufficient additional dosage to overcome the inhibitor would be needed.22,23

Reconstitution: Use Aseptic Technique

  1. Bring PROPLEX T, Factor IX Complex, Heat Treated (dry concentrate) and Sterile Water for Injection, USP, (diluent) to room temperature.
  2. Remove caps from concentrate and diluent bottles to expose central portions of rubber stoppers.
  3. Cleanse stoppers with germicidal solution.
  4. Remove protective covering from one end of double-ended needle and insert exposed needle through diluent stopper.
  5. Remove protective covering from other end of double-ended needle. Invert diluent bottle over the upright concentrate bottle, then rapidly insert free end of the needle through the concentrate bottle stopper at its center. The vacuum in the concentrate bottle will draw in the diluent.
  6. Disconnect the two bottles by removing needle from diluent bottle stopper, then remove needle from concentrate bottle. Swirl or rotate concentrate bottle until all material is dissolved. Be sure that the material is completely dissolved, otherwise active material will be removed by the filter.

Note: Do not refrigerate after reconstitution.

Rate of Administration

PROPLEX T, Factor IX Complex, Heat Treated should be infused slowly, at a rate of approximately two to three mL per minute. If headache, flushing, changes in pulse rate or blood pressure appear, the infusion rate should be decreased. In such instances it is advisable, initially, to stop the infusion until the symptoms disappear, then resume the infusion at a slower rate.

Administration: Use Aseptic Technique

When reconstitution of PROPLEX T, Factor IX Complex, Heat Treated is complete, its infusion should commence within three hours. However, it is recommended that the infusion begin as promptly as is practical.

The reconstituted material should be at room temperature during infusion. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Intravenous Drip Infusion

Follow directions for use printed on the administration set container. Make certain that the administration set contains an adequate filter.

Intravenous Syringe Injection

  1. Attach filter needle to syringe and draw back plunger to admit air into the syringe.
  2. Insert needle into the reconstituted PROPLEX T, Factor IX Complex, Heat Treated.
  3. Inject air into bottle and then withdraw the reconstituted material into the syringe.
  4. Remove and discard the filter needle from the syringe; attach a suitable needle and inject intravenously at a rate not exceeding 3 mL per minute.
  5. If patient is to receive more than one bottle of concentrate, the contents of two bottles may be drawn into the same syringe by drawing up each bottle through a separate unused filter needle. This practice lessens the loss of concentrate. Please note: filter needles are intended to filter the contents of a single bottle of PROPLEX T, Factor IX Complex, Heat Treated only.

HOW SUPPLIED

PROPLEX T, Factor IX Complex, Heat Treated is furnished with a suitable volume of Sterile Water for Injection, USP; a double-ended needle; a filter needle; and package insert.

Storage

PROPLEX T, Factor IX Complex, Heat Treated should be stored under ordinary refrigeration (2° to 8°C, 36° to 46°F). Avoid freezing to prevent damage to the diluent bottle.

To enroll in the confidential, industry-wide Patient Notification System, call 1-888-UPDATE U (1-888-873-2838).

REFERENCES

4. Zauber NP, Levin J: Factor IX levels in patients with hemophilia B (Christmas disease) following transfusion with concentrates of Factor IX or fresh frozen plasma (FFP). Medicine 56:213-224, 1977

12. Lusher JM, Shapiro SS, Palascak JE, et al: Efficacy of prothrombin-complex concentrates in hemophiliacs with antibodies to Factor VIII. A multicenter therapeutic trial. New Eng J Med 303:421-425, 1980

13. Ragni MV, Lewis JH, Spero JA, et al: Factor VII deficiency. Am J Hemotology 10: 79-88, 1981

19. Levine PH: Hemophilia and allied conditions, in Current Therapy, 1979. Conn HF (ed), Philadelphia, W.B. Saunders Co., 1979, pp 268-275

20. Nilsson IM: Clinical experience with a Swedish Factor IX concentrate, in Haemophilia. Ala F, Denson KWE(eds), Amsterdam, Excerpta Medica, 1973, pp 249-253

21. Owen CA Jr, Bowie EJW: Infusion therapy in hemophilia A and B, in Handbook of Hemophilia. Brinkhous KM, Hemker HC (eds), Amsterdam, Excerpta Medica, 1975, pp 449-473

22. Hoag MS, Aggeler PM, Fowell AH: Disappearance rate of concentrated proconvertin extracts in congenital and acquired hypoproconvertinemia. J Clin Invest 39:554-563, 1960

23. Bedizel M, Albers R: Hereditary Factor VII deficiency in newborns. Clinical Pediatrics 22:774-775, 1983

Baxter Healthcare Corporation, Westlake Village, CA 91362, USA. Revised November 2002.

Last reviewed on RxList: 3/5/2009
This monograph has been modified to include the generic and brand name in many instances.

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