Monoclate-P^®

Antihemophilic Factor (Human) Factor VIII:C Pasteurized Monoclonal Antibody Purified

Q. How should Monoclate-P^® be stored?

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

Q. Are there any contraindications for Monoclate-P^®?

A. Known allergies to mouse protein is a contraindication for Monoclate-P^®. This is because mouse antibody proteins to the von Willebrand factor/factor VIII complex are used in the patented monoclonal antibody (MAb) immunoaffinity chromatography process in order to remove only the factor VIII from human plasma. This produces the highest purity plasma-derived factor VIII concentrate.

Q. Does Monoclate-P^® contain human albumin?

A. Monoclate-P^® does contain human albumin. This is necessary because in human blood factor VIII is connected to von Willebrand factor. When an ultrahigh-purity product such as Monoclate-P^® is manufactured, factor VIII is separated from the von Willebrand factor. This makes the factor VIII very unstable. It is necessary to add albumin to stabilize the factor VIII so it maintains its efficacy.

Q. Does the manufacturing process for Monoclate-P^® include viral elimination/reduction steps?

A. Yes. Monoclate-P^® is pasteurized, heating in aqueous solution at 60°C for 10 hours. This method of viral inactivation has demonstrated reduction of both lipid-enveloped viruses (such as hepatitis B and C, HIV, and herpes viruses) and certain non-lipid-enveloped viruses (such as hepatitis A, parvo B19, and polio) in validation experiments. The patented monoclonal antibody (MAb) immunoaffinity chromatography purification process is designed to help eliminate viruses. In this process, murine antibodies specific to a single target protein (such as factor VIII) are placed in a chromatography column. When plasma is passed through the column, the antibodies bind the target protein; extraneous proteins (such as viruses and unwanted clotting factors) pass through. In over 10 years, and more than 1 billion units infused, there have been no confirmed reports of viral transmissions with Monoclate-P^®. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Q. What is the safety record of Monoclate-P^®?

A. In more than 10 years of use and over 1 billion units dispensed, there have been no confirmed cases of viral transmissions with the use of Monoclate-P^®. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

Q. What percent of hemophilia patients receiving Monoclate-P^® develop inhibitors?

A. Approximately 18% of previously untreated hemophilia patients receiving Monoclate-P^® develop inhibitors. This falls in the range of expected inhibitor development for all factor VIII products.

Q. Is Monoclate-P^® considered an ultrahigh-purity factor VIII product?

A. Monoclate-P^® is considered an ultrahigh-purity factor VIII product because of the patented monoclonal antibody (MAb) immunoaffinity chromatography process used in its manufacture. The chromatography process used determines the degree of purity of the finished product; that is, the degree in which the target protein (factor VIII) is separated from unwanted proteins. A high degree of purity is critical because the presence of unwanted proteins may decrease therapeutic efficacy.

Important Safety Information

Monoclate-P^® is contraindicated in patients with known hypersensitivity to mouse protein.

Products of this type are known to cause allergic reactions, mild chills, nausea or stinging at the infusion site. In some cases, inhibitors of FVIII may occur.

Monoclate-P^® is derived from human plasma. As with all plasma-derived products, the risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease agent, cannot be completely eliminated.