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Alphanate

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Alphanate

Indications
Dosage
How Supplied

INDICATIONS

Antihemophilic Factor (Human), Alphanate (antihemophilic factor) ®, is indicated for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency.7 No clinical trials have as yet been conducted using Alphanate (antihemophilic factor) ® for treatment of von Willebrand's disease, therefore the product is not approved for this use.

DOSAGE AND ADMINISTRATION

For adult usage

Following reconstitution with the supplied diluent, Alphanate (antihemophilic factor) ® should be administered intravenously within three hours after reconstitution to avoid the potential ill effect of any inadvertent bacterial contamination occurring during reconstitution. Alphanate (antihemophilic factor) ® may be administered by injection (plastic disposable syringes are recommended). Administer at room temperature, do not refrigerate after reconstitution, and discard any unused contents into the appropriate safety container.

Antihemophilic factor potency (Factor VIII:C activity) is expressed in International Units (IU) on the product label. One unit approximates the activity in one mL of normal human plasma. Replacement therapy studies have shown a linear dose-response relationship with a 2.0-2.5% increase in Factor VIII activity for each unit of Factor VIII:C per kg of body weight transfused, from which an approximate factor of 0.5 lU/kg can be calculated.15,16

The following formula provides a guide for dosage calculation (the plasma Factor VIII may vary depending upon the age, weight, severity of hemorrhage, or surgical procedure of the patient):

Bodyweight (in kg) X 0.50 lU/kg X Factor VIII Increase Desired (Percent) = Number of Factor VIII:C IU Required

Example:

50 kg X 0.50 lU/kg X 30 (% increase) = 750 IU Factor VIII:C

Mild to moderate hemorrhages can usually be treated with a single administration of Alphanate (antihemophilic factor) ® sufficient to raise the plasma Factor VIII level to 20 to 30%. In the event of more serious hemorrhage, the patient's plasma Factor VIII level should be raised to 30 to 50%. Infusions are generally required at twice daily intervals over several days.16

Surgery in patients with Factor VIII deficiency requires that postoperatively the Factor VIII level be raised to 50 to 80% and maintained at or above 30% for approximately two weeks. For dental extractions, the Factor VIII level should be raised to 50% immediately prior to the procedure; additional Alphanate (antihemophilic factor) ® may be given if bleeding recurs.17

In patients with severe Factor VIII deficiency who experience frequent hemorrhages, Antihemophilic Factor (Human), Alphanate (antihemophilic factor) ®, may be administered prophy-lactically on a daily or every other day schedule to raise the Factor VIII level to approximately 15%.18

Factor VIII levels should be monitored periodically to evaluate individual patient response to the dosage regime.

For pediatric usage

See PRECAUTIONS

RECONSTITUTION

Always Use Aseptic Technique

  1. Warm diluent (Sterile Water for Injection, USP) and concentrate (Alphanate (antihemophilic factor) ®) to at least room temperature (but not above 37 °C).
  2. Remove plastic caps from the diluent and concentrate vials.
  3. Swab the exposed stopper surfaces with a cleansing agent such as alcohol. Do not leave excess cleansing agent on the stoppers.
  4. Remove cover from one end of the double-ended transfer needle. Insert the exposed end of the needle through the center of the stopper in the DILUENT vial.
  5. Remove plastic cap from the other end of the double-ended transfer needle now seated in the stopper of the diluent vial. To reduce any foaming, invert the vial of diluent and insert the exposed end of the needle through the center of the stopper in the CONCENTRATE vial at an angle, making certain that the diluent vial is always above the concentrate vial. The angle of insertion directs the flow of diluent against the side of the concentrate vial. Refer to Figure 1. There should be enough vacuum in the vial to transfer all of the diluent.
  6. The angle of insertion directs the flow of diluent against the side of the concentrate vial - illustration

    Figure 1

  7. Disconnect the two vials by removing the transfer needle from the diluent vial stopper. Remove the double-ended transfer needle from the concentrate vial and discard the needle into the appropriate safety container.
  8. Let the vial stand until contents are in solution, then GENTLY swirl until all concentrate is dissolved. Reconstitution requires less than 5 minutes.
  9. DO NOT SHAKE THE CONTENTS OF THE VIAL. DO NOT INVERT THE CONCENTRATE VIAL UNTIL READY TO WITHDRAW CONTENTS.
  10. Use as soon as possible after reconstitution.
  11. After reconstitution, parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. When reconstitution procedure is strictly followed, a few small particles may occasionally remain. The microaggregate filter will remove particles and the labeled potency will not be reduced.

ADMINISTRATION BY SYRINGE

Use Aseptic Technique

  1. Peel cover from microaggregate filter package and securely install the syringe into the exposed Luer inlet of the filter, using a slight clockwise twisting motion.
  2. Remove filter from packaging. Remove protective cover from the spike end of the filter.
  3. Pull back plunger drawing sufficient air into the syringe to allow reconstituted product to be withdrawn as described in the next step.
  4. Insert the spike end of the filter into the reconstituted concentrate vial. Inject air (Figure 2a) and withdraw the reconstituted product from the vial into the syringe (Figure 2b).
  5. Inject air - illustration Withdraw the reconstituted product from the vial into the syringe - illustration

    Figure 2a               Figure 2b

  6. Remove the filter from the syringe; discard the filter and the empty concentrate vial, into the appropriate safety container. Attach syringe to an infusion set, expel air from the syringe and infusion set. Perform venipuncture and administer slowly at a rate not exceeding 10 mL/minute.
  7. If the patient is to receive more than one vial of concentrate, the infusion set will allow administration of multiple vials to be performed with a single venipuncture.
  8. Discard all administration equipment after use into the appropriate safety container. Do not reuse.

HOW SUPPLIED

Alphanate (antihemophilic factor) ® is supplied in sterile, lyophilized form in single dose vials accompanied by a suitable volume of diluent (Sterile Water for Injection, USP), according to AHF potency. Each vial is labeled with the Factor VIIIC potency expressed in AHF International Units. Alphanate (antihemophilic factor) ® is packaged with a double-ended transfer needle and microaggregate filter for use in administration.

Storage

Alphanate (antihemophilic factor) ® should be stored at temperatures between 2 and 8 °C. Do not freeze to prevent damage to diluent vial. May be stored at room temperature not to exceed 30 °C for up to 2 months. When removed from refrigeration, record the date removed on the space provided on the carton.

REFERENCES

7. Eyster, M.E. Hemophilia: A Guide for the Primary Care Physician. Postgraduate Medicine 1978, 64:75-81.

15. Shanbrom, E., Thelin, M. Experimental Prophylaxis of Severe Hemophilia with a Factor VIII Concentrate. JAM A 1969, 208(9): 1 853-1 856.

16. Levine, P.H. Hemophilia and Allied Conditions. In: Current Therapy in Hematology-On-cology: 1983-1984. Brain, M.C. (ed) New York: BC Decker, 1983, pp. 147-152.

17. Kasper, C.K. Hemophilia and Hemophilioid Disorders. In: Conn, H.F., ed. Current Therapy, 4th ed., Philadelphia: Saunders, 1974, pp. 258-263.

18. Kasper, C.K., Dietrich, S.L., Rapaport, S.I. Hemophilia Prophylaxis with Factor VIII Concentrate. Arch Intern Med 1970, 125:1004-1009.

Manufactured by: Grifols Biologicals Inc., Los Angeles, CA 90032, USA. Revised January 2004. FDA rev date: n/a

Last reviewed on RxList: 11/14/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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