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Monoclate-P

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Monoclate-P

Antihemophilic Factor (Human)
Monoclate-P®
Factor VIII:C Pasteurized Monoclonal Antibody Purified




DRUG DESCRIPTION

Antihemophilic Factor (Human), Monoclate-P®, Factor VIII:C Pasteurized, Monoclonal Antibody Purified, is a sterile, stable, lyophilized concentrate of Factor VIII:C with reduced amounts of VWF:Ag and purified of extraneous plasma-derived protein by use of affinity chromatography. A murine monoclonal antibody to VWF:Ag is used as an affinity ligand to first isolate the Factor VIII Complex. Factor VIII:C is then dissociated from VWF:Ag, recovered, formulated and provided as a sterile lyophilized powder.1,2,3 The concentrate as formulated contains Albumin (Human) as a stabilizer, resulting in a concentrate with a specific activity between 4 and 10 units/mg of total protein. In the absence of this added Albumin (Human) stabilizer, specific activity has been determined to exceed 3000 units/mg of protein.4 Monoclate-P® has been prepared from pooled human plasma and is intended for use in therapy of classical hemophilia (Hemophilia A).

All Source Plasma used in the manufacture of this product was tested by FDA-licensed Nucleic Acid Testing (NAT) for HBV, HCV, and HIV-1 and found to be nonreactive (negative). This concentrate has been pasteurized by heating at 60°C for 10 hours in aqueous solution form during its manufacture in order to further reduce the risk of viral transmission.5 However, no procedure has been shown to be totally effective in removing viral infectivity from coagulant factor concentrates (see CLINICAL PHARMACOLOGY and WARNINGS).

Monoclate-P® is a highly purifi ed preparation of Factor VIII:C. When stored as directed, it will maintain its labeled potency for the period indicated on the container and package labels.6,7 Upon reconstitution of the 250, 500 and 1000 I.U. concentrates, a clear, colorless solution is obtained, containing 50 to 150 times as much Factor VIII:C as does an equal volume of plasma.

Upon reconstitution of the 1500 I.U. concentrate, a clear, colorless solution is obtained, containing 120 to 180 times as much Factor VIII:C as does an equal volume of plasma. Each vial contains the labeled amount of antihemophilic factor (AHF) activity as expressed in terms of International Units (I.U.) of antihemophilic activity. One unit of antihemophilic activity is equivalent to that quantity of AHF present in one mL of normal human plasma. When reconstituted as recommended, the resulting solution contains approximately 300 to 450 millimoles of sodium ions per liter and has 2 to 3 times the tonicity of saline. It contains approximately 2-5 millimoles of calcium ions per liter, contributed as calcium chloride, approximately 1 to 2% Albumin (Human), 0.8% mannitol, and 1.2 mM histidine. The pH is adjusted with hydrochloric acid and/or sodium hydroxide. Monoclate-P® also contains trace amounts ( ≤ 50 ng per 100 I.U. of AHF) of the murine monoclonal antibody used in its purification (see CLINICAL PHARMACOLOGY).

Monoclate-P® is to be administered only intravenously.

REFERENCES

1. W. Terry, A. Schreiber, C. Tarr, M. Hrinda, W. Curry and F. Feldman, Human Factor VIII:C Produced Using Monoclonal Antibodies, in Research in Clinic and Laboratory, Vol. XVI, (#1), 202 (1986) from the XVIIth International Congress of the World Federation of Hemophilia.

2. A. B. Schreiber, The Preclinical Characterization of Monoclate Factor VIII C Antihemophilic Factor Human, Semin Hematol 25 (2 Suppl. 1), 1988, pp. 27-32.

3. E. Berntorp and I.M. Nilsson, Biochemical Properties of Human Factor VIII C Monoclate Purified Using Monoclonal Antibody to VWF, Thromb Res O (Suppl. 7), 1987, p. 60, from the Satellite Symposia of the XIth International Congress on Thrombosis and Haemostasis, Brussels, Belgium, July 11, 1987.

4. S. Chandra, C.C. Huang, R.L. Weeks, K. Beatty and F. Feldman, Purity of a Factor VIII:C Preparation (Monoclate) Manufactured by Monoclonal Immunoaffi nity Chromatography Technique, from the XVIII International Congress of the World Federation of Hemophilia, May 1988.

5. B. Spire, D. Dormont, F. Barre-Sinousii, L. Montagnier, and J.C. Chermann, Inactivation of Lymphadenopathy Associated Virus by Heat, Gamma Rays, and Ultraviolet Light, Lancet, Jan. 26, 1985, p. 188.

6. F. Feldman, R. Kleszynski, L. Ho, R. Kling, S. Chandra and C.C. Huang, Validation of Coagulation Test Methods for Evaluation of Monoclate (Factor VIII:C) Potencies, from the XVIII International Congress of the World Federation of Hemophilia, May 1988.

7. S. Chandra, C.C. Huang, L. Ho, R. Kling, R.L. Weeks and F. Feldman, Studies on the Stability of Factor VIII:C (Monoclate) in Lyophilized and Solution Form, from the XVIII International Congress of the World Federation of Hemophilia, May 1988.

What are the possible side effects of human antihemophilic factor (Hemofil-M, Koate-DVI, Monarc-M, Monoclate-P)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • easy bruising, increased bleeding episodes;
  • bleeding from a wound or where the medicine was injected;
  • fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later; or
  • nausea,...

Read All Potential Side Effects and See Pictures of Monoclate-P »

Last reviewed on RxList: 6/28/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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