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Monoclate-P

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Monoclate-P

Indications
Dosage
How Supplied

INDICATIONS

Monoclate-P® (antihemophilic factor) is indicated for treatment of classical hemophilia (Hemophilia A). Affected individuals frequently require therapy following minor accidents. Surgery, when required in such individuals, must be preceded by temporary corrections of the clotting abnormality. Surgical prophylaxis in severe AHF deficiency can be accomplished with an appropriately-dosed pre-surgical IV bolus of Monoclate-P® (antihemophilic factor) followed by intermittent maintenance doses (see DOSAGE AND ADMINISTRATION).

Monoclate-P® (antihemophilic factor) is not effective in controlling the bleeding of patients with von Willebrand's disease.

DOSAGE AND ADMINISTRATION

Monoclate-P® (antihemophilic factor) is for intravenous administration only. As a general rule 1 unit of AHF activity per kg will increase the circulating AHF level by 2%.10 The following formula10 provides a guide of dosage calculations for both adult and pediatric patients:

Number of AHF
I.U. Required
= Body weight
(in kg)
x desired Factor VIII increase
(% normal)
x 0.5

Although dosage must be individualized according to the needs of the patient (weight, severity of hemorrhage, presence of inhibitors), the following general dosages are suggested.11

  1. MILD HEMORRHAGES - Minor hemorrhagic episodes will generally subside with a single infusion if a level of 30% or more is attained.
  2. MODERATE HEMORRHAGE AND MINOR SURGERY - For more serious hemorrhages and minor surgical procedures, the patient's Factor VIII level should be raised to 30-50% of normal, which usually requires an initial dose of 15-25 I.U. per kg. If further therapy is required a maintenance dose is 10-15 I.U. per kg every 8-12 hours.
  3. SEVERE HEMORRHAGE - In hemorrhages near vital organs (neck, throat, subperitoneal) it may be desirable to raise the Factor VIII level to 80-100% of normal which can be achieved with an initial dose of 40-50 I.U. per kg and a maintenance dose of 20-25 I.U. per kg every 8-12 hours.
  4. MAJOR SURGERY - For surgical procedures a dose of AHF sufficient to achieve a level 80-100% of normal should be given an hour prior to surgery. A second dose, half the size of the priming dose, should be given five hours after the first dose. Factor VIII levels should be maintained at a daily minimum of at least 30% for a period of 10-14 days postoperatively. Close laboratory control to maintain AHF plasma levels deemed appropriate to maintain hemostasis is recommended.

Reconstitution

  1. Warm both the diluent and Monoclate-P® (antihemophilic factor) in unopened vials to room temperature [not above 37°C (98°F)].
  2. Remove the caps from both vials to expose the central portions of the rubber stoppers.
  3. Treat the surface of the rubber stoppers with antiseptic solution and allow them to dry.
  4. Using aseptic technique, insert one end of the double-end needle into the rubber stopper of the diluent vial. Invert the diluent vial and insert the other end of the double-end needle into the rubber stopper of the Monoclate-P® (antihemophilic factor) vial. Direct the diluent, which will be drawn in by vacuum, over the entire surface of the Monoclate-P® (antihemophilic factor) cake. (In order to assure transfer of all the diluent, adjust the position of the tip of the needle in the diluent vial to the inside edge of the diluent stopper.) Rotate the vial to ensure complete wetting of the cake during the transfer process.
  5. Remove the diluent vial to release the vacuum, then remove the double-end needle, from the Monoclate-P® (antihemophilic factor) vial.
  6. Gently swirl the vial until the powder is dissolved and the solution is ready for administration. The concentrate routinely and easily reconstitutes within one minute. To assure sterility, Monoclate-P® (antihemophilic factor) should be administered within three hours after reconstitution.
  7. Parenteral drug preparations should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Administration

CAUTION: This kit contains two devices, a stainless steel 5 micron filter needle, individually labeled as a 5 micron filter needle and contained in a separate blister pack, and an all plastic 5 micron vented filter spike which is supplied with the four-item administration components blister pack, either of which may be used to withdraw the reconstituted product for administration. The withdrawal directions specific for each of these alternate devices must be followed exactly for whichever device is chosen for use as described below. Product loss or inability to withdraw product will result if the improper instructions are followed.

A. Administration using the stainless steel filter needle for withdrawal (This item is individually packaged in a separate, labeled blister pack.)

Intravenous Injection

Plastic disposable syringes are recommended with Monoclate-P® (antihemophilic factor) solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.

  1. Using aseptic technique, attach the filter needle to a sterile disposable syringe.
  2. Draw air into the syringe equal to or greater than the contents of the vial.
  3. Insert the filter needle into the stopper of the Monoclate-P® (antihemophilic factor) vial, invert the vial, position the filter needle above the level of the liquid and inject all of the air into the vial.
  4. Pull the filter needle back down below the level of the liquid until the tip is at the inside edge of the stopper.
  5. Withdraw the reconstituted solution into the syringe being careful to always keep the tip of the needle below the level of the liquid.
    CAUTION: Failure to inject air into the vial, or allowing air to pass through the filter needle while filling the syringe with reconstituted solution, may cause the needle to clog.
  6. Discard the filter needle. Perform venipuncture using the enclosed winged needle with microbore tubing. Attach the syringe to the luer end of the tubing.
    CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set.
  7. Administer solution intravenously at a rate (approximately 2 mL/minute) comfortable to the patient.

B. Administration using the all plastic vented filter spike for withdrawal (This spike is supplied in the four-item Administration Components pack.)

Intravenous Injection

Plastic disposable syringes are recommended with Monoclate-P® (antihemophilic factor) solution. The ground glass surfaces of all-glass syringes tend to stick with solutions of this type.

  1. Using aseptic technique, attach the vented filter spike to a sterile disposable syringe.
    CAUTION: DO NOT INJECT AIR INTO THE MONOCLATE-P® (antihemophilic factor) VIAL. The self-venting feature of the vented filter spike precludes the need to inject air in order to facilitate withdrawal of the reconstituted solution. The injection of air could cause partial product loss through the vent filter.
    CAUTION: The use of other, non-vented filter needles or spikes without the proper procedure may result in an air lock and prevent the complete transfer of the concentrate.
  2. Insert the vented filter spike into the stopper of the Monoclate-P® (antihemophilic factor) vial, invert the vial, and position the filter spike so that the orifice is at the inside edge of the stopper.
  3. Withdraw the reconstituted solution into the syringe.
  4. Discard the filter spike. Perform venipuncture using the enclosed winged needle with microbore tubing. Attach the syringe to the luer end of the tubing.
    CAUTION: Use of other winged needles without microbore tubing, although compatible with the concentrate, will result in a larger retention of solution within the winged infusion set.
  5. Administer solution intravenously at a rate (approximately 2 mL/minute) comfortable to the patient.

Storage

When stored at refrigerator temperature, 2-8°C (36-46°F), Monoclate-P® (antihemophilic factor) is stable for the period indicated by the expiration date on its label. Within this period, Monoclate-P® (antihemophilic factor) may be stored at room temperature not to exceed 25°C (77°F), for up to 6 months.

Avoid freezing which may damage container for the diluent.

HOW SUPPLIED

Monoclate-P® (antihemophilic factor) is supplied in a single dose vial with diluent, double-ended needle for reconstitution, vented filter spike for withdrawal, filter needle for withdrawal, winged infusion set and alcohol swabs. I.U. activity is stated on the label of each vial.

The following strengths are available:

NDC 0053-7656-01 in 10 mL vials containing approximately 250 I.U.
(Dosage – LOW)
NDC 0053-7656-02 in 10 mL vials containing approximately 500 I.U.
(Dosage – MID)
NDC 0053-7656-04 in 20 mL vials containing approximately 1000 I.U.
(Dosage – HIGH)
NDC 0053-7656-05 in 20 mL vials containing approximately 1500 I.U.
(Dosage – Super High)

REFERENCES

10. C.F. Abilgaard, J.V. Simone, J.J. Corrigan, et al., Treatment of Hemophilia with Glycine - Precipitated Factor VIII, New Eng J Med, 275 (1966), p. 471.

11. C.K. Kasper, Hematologic Care, Comprehensive Management of Hemophilia, ed. Boone, D.C., Philadelphia, F.A. Davis Co., (1976) pp. 2-20.

BIBLIOGRAPHY

Hershman, R.J., Naconti, S.B., and Shulman, N.R. Prophylactic Treatment of Factor VIII Deficiency. Blood 35, (1970), p. 189.

Kasper, C.K. Dietrich, S.I. and Rapaport, S.K. Hemophilia Prophylaxis in Factor VIII Concentrate. Arch Int Med 125, (1970), p. 1004.

Biggs, R. ed. The Treatment of Hemophilia A and B and von Willebrands Disease. Oxford: Blackwell, 1978.

Fulcher, C.A., Zimmerman, T.S., Characterization of the Human Factor VIII Procoagulant Protein With A Heterologous Precipitating Antibody. Proc Natl Acad Sci 79 (1982), pp. 1648-1652.

Levine, P.H., Factor VIII C Purified from Plasma Via Monoclonal Antibodies Human Studies. Semin Hematol 25 (2 Suppl. 1), 1988, pp. 38-41.

Manufactured by: CSL Behring LLC, Kankakee, IL 60901 USA. Revised January, 2007

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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