Mononine^®

Coagulation Factor IX (Human) Monoclonal Antibody Purified

Q. Does Mononine^® have any contraindications?

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

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

A. Yes. The monoclonal antibody (MAb) immunoaffinity chromatography, sodium thiocyanate incubation, and YM 100 filtration employed in the manufacture of Mononine^® have demonstrated reduction of both lipid-enveloped viruses (such as HIV and hepatitis B and C) and certain non-lipid-enveloped viruses (such as hepatitis A and parvo B19) in validation experiments. The patented MAb immunoaffinity chromatography purification process is designed to help eliminate viruses. In this process, antibodies specific to a single target protein (such as factor IX) 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. Sodium thiocyanate, which is used to remove the factor IX from the chromatography column, has been shown to be effective in inactivating HIV. The YM 100 filtration is a viral retentive process which the product passes through twice. These pores are large enough to allow factor IX to pass through but designed to trap the smallest known viruses. More than 450 million units of Mononine^® have been infused since 1992 without any confirmed reports of thrombotic events or viral transmissions. 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. How should Mononine^® be stored?

A. Mononine^® should be refrigerated at 2°-8°C (36°-46°F). Within this period, Mononine^® may be stored at room temperature not to exceed 25°C (77°F) for up to one month. Avoid freezing to prevent damage to the diluent vial.

Q. Is there a difference in recovery between Mononine^® and BeneFIX^®?

A. In a well-controlled clinical trial comparing Mononine^® and BeneFIX^®*, Mononine^® demonstrated twice the in vivo recovery as BeneFIX^®. This difference was statistically significant. Fewer units of Mononine^® are needed to achieve the same factor IX plasma levels as recombinant factor IX. The dosing calculation for BeneFIX^® does state a multiplication factor of 1.2 compared to 1.0 for Mononine^®.

*BeneFIX^® is a registered trademark of Genetics Institute.

Q. What is the viral safety record of Mononine^®?

A. More than 450 million units of Mononine^® have been infused since 1992 without any confirmed reports of thrombotic events or viral transmissions. 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.

Important Safety Information

Mononine^® is contraindicated in patients with known hypersensitivity to mouse protein.

The following adverse reactions may be observed after administration: headache, fever, chills, flushing, nausea, vomiting, tingling, lethargy, hives, stinging or burning at the infusion site, or other manifestations of allergic reactions, including anaphylaxis.

Mononine^® 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 (CJD) agent, cannot be completely eliminated.

Since the use of Factor IX Complex concentrates has historically been associated with the development of thromboembolic complications, the use of Factor IX-containing products may be potentially hazardous in patients with signs of fibrinolysis and in patients with disseminated intravascular coagulation.