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.
