12/4/2017 Mononine ® United States Home > US Products > Mononine® Mononine ® Coagulation Factor IX (Human) Monoclonal Antibody Purified Full Prescribing Information for Mononine® Important Safety Information Mononine is indicated for the prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease. A high-purity factor IX product with a track record of over half a billion units infused since 1992 without any confirmed cases of thrombotic events or viral transmissions Unique three-step viral inactivation and removal process designed to protect against both lipid-enveloped and certain non-lipid- enveloped viruses Peel-off labels designed for patient convenience Diagnostic Codes (ICD-10-CM) ICD-10-CM Codes Used to identify patient medical conditions (for claims with a date of service on or after October 1, 2015) Code Description D67 Hereditary factor IX deficiency 30233W1 Transfusion of Nonautologous Factor IX into peripheral vein, percutaneous approach 30243W1 Transfusion of Nonautologous Factor IX into central vein, percutaneous approach Billing Codes (HCPCS, NDC, CPT) HCPCS Codes The following HCPCS codes describe supplies (including drugs) rendered by the billing provider. CMS publishes and maintains the HCPCS code set. These codes are entered to paper claim form CMS-1500 in Field 24; or, to electronic claim form ASC 837P in Loop 2400, Segment SV101-2, with the Qualifier "HC" entered to Segment SV101-1, unless otherwise directed by the payor. Code Description J7193 FACTOR IX (ANTIHEMOPHILIC FACTOR, PURIFIED, NON-RECOMBINANT) PER IU NDC Codes Certain payors may require the entry of NDC information to the claim form, as directed by the payor. Approximate FVIII activity per NDC Number vial 500 IU 00053-6232-02 1000 IU 00053-6233-02 CPT Codes If the billing provider performs administration services in conjunction with a patient's infusion, the following administration codes may be used to bill for this service if the service meets the requirements of the code description. Code Description 96365 Intravenous infusion for therapy, prophylaxis or diagnosis (specify substance or drug); intial up to 1 hour. 96366 Each additional hour 96374 Intravenous push, single or initial substance/drug 96376 Each additional sequential intravenous push of the same substance/drug provided in a facility http://www.cslbehring-us.com/products/Mononine.htm 1/2 12/4/2017 Mononine ® Authorized Distributors Companies ABO Pharmaceuticals ASD Healthcare/AmeriSourceBergen Atlantic Biologics Corp BCA BDI Pharma BioCare Cardinal Health Specialty Pharmaceutical Distribution CT International FFF Enterprises Health Coalition HMPG Pharmacy LLC Lifeline Pharmaceuticals LLC McKesson Plasma & Biologicals LLC National Hospital Specialties New York Blood Center Prodigy Health Provider Smith Medical Partners Safety Data Sheets Safety Data Sheets (SDS) for Mononine. Important Safety Information for Mononine Coagulation Factor IX (Human), Mononine ®, is indicated for the prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease. Mononine is not indicated in the treatment or prophylaxis of Hemophilia A patients with inhibitors to Factor VIII. 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. 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 (DIC). Please see full prescribing information for Mononine. http://www.cslbehring-us.com/products/Mononine.htm 2/2.