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Alphanate

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Alphanate

ALPHANATE©
(antihemophilic factor) (HUMAN)

Solvent Detergent / Heat Treated

DRUG DESCRIPTION

Antihemophilic Factor (Human), Alphanate (antihemophilic factor) ®, Solvent Detergent / Heat Treated, is a single dose, sterile, lyophilized concentrate of Factor VIII (AHF) intended for intravenous administration in the treatment of hemophilia A, or acquired Factor VIII deficiency.

Alphanate (antihemophilic factor) ® is prepared from pooled human plasma by cryoprecipitation of the Factor VIII, fractional solubilization, and further purification employing heparin-coupled, cross-linked agarose which has an affinity to the heparin binding domain of vWf/FVIII:C complex.1 The product is treated with a mixture of tri(n-butyl) phosphate (TNBP) and polysorbate 80 to reduce the risks of transmission of viral infection. In order to provide an additional safeguard against potential non-lipid enveloped viral contaminants, the product is also subjected to a 80 °C heat treatment step for 72 hours. However, no procedure has been shown to be totally effective in removing viral infectivity from coagulation factor products.

Alphanate® is labeled with the antihemophilic factor potency (Factor VIIIC activity) expressed in International Units (I U) per vial, which is referenced to the WHO International Standard.

Alphanate (antihemophilic factor) ® contains Albumin (Human) as a stabilizer, resulting in a final container concentrate with a specific activity of at least 5 IU FVIII:C/mg total protein. Prior to the addition of the Albumin (Human) stabilizer, the specific activity is significantly higher.

When reconstituted with the appropriate volume of Sterile Water for Injection, USP, Alphanate (antihemophilic factor) ® contains 0.3 - 0.9 g Albumin (Human)/100 mL; NMT 5 mmol calcium/L; NMT 750 µg glycine/IU FVIIIC; NMT 1.0 U heparin/mL; 10 - 40 mmol histidine/L; NMT 0.1 mg imidazole/mL; 50 - 200 mmol arginine/L; NMT 1.0 µg polyethylene glycol and polysorbate 80/IU FVIII:C; NMT 10 mEq sodium/vial; and NMT 0.1 µg TNBP/IU FVIIIC.

What are the precautions when taking antihemophilic factor (Alphanate)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Alphanate »

REFERENCES

What are the precautions when taking antihemophilic factor (Alphanate)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Alphanate »

1. Fujimura, Y., Titani, K., Holland, L.Z., Roberts, J.R., Kostel, P., Ruggeri, Z.M., Zimmerman, T.S. A Heparin-Binding Domain of Human Von Willebrand Factor: Characterization and Localization to a Tryptic Fragment Extending from Amino Acid Residue Val-449 to Lys-728. I Biol Chem 1987, 262(4): 1 734-1 739.

What are the precautions when taking antihemophilic factor (Alphanate)?

Before using this medication, tell your doctor or pharmacist if you are allergic to any antihemophilic factor (factor VIII) products; or to animal proteins (e.g., mouse); or to natural rubber/latex (found in the packaging of some brands); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Manufacturers of some brands of this medication recommend that you monitor your heartbeat during treatment. If your heart starts to beat faster, it is recommended that you give this medication more slowly or temporarily stop the infusion until your heart rate returns to normal....

Read All Potential Precautions of Alphanate »

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

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