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Factor Ix Concentrate

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Factor Ix Concentrate BLOOD PRODUCT FACT SHEET FACTOR IX CONCENTRATE Other Names BeneFIX® , ALPROLIXTM Consent Required No. Factor IX is a recombinant product and not a plasma derived factor concentrate. Pre-Transfusion Not Required Sample Approval Hematopathologist approval is required for: Requirements • Patients who do not have a diagnosis of Hemophilia B Product Description BeneFIX Coagulation Factor IX (Recombinant): • is formulated as a sterile, nonpyrogenic, lyophilized powder preparation • is a clear, colorless solution after reconstitution • is supplied in 250 IU, 500 IU, 1000 IU, 2000 IU and 3000 IU vials ALPROLIX (Coagulation Factor IX (Recombinant), Fc Fusion Protein): • is formulated as a sterile, non-pyrogenic, preservative-free, white to off-white, lyophilized powder • is a long-acting antihemophilic factor • is supplied in 250 IU, 500 IU, 1000 IU, and 2000 IU vials Clinical Indications BeneFIX is indicated for: • the control and prevention of hemorrhagic episodes • routine prophylaxis in patients with hemophilia B • control and prevention of bleeding in surgical settings ALPROLIX (a long-acting antihemophilic factor) is indicated for: • routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes • control and prevention of bleeding episodes Contraindications • Treatment of other factor deficiencies. • Treatment of hemophilia A patients with inhibitors to Factor VIII. • Reversal of warfarin-induced anticoagulation. • Treatment of bleeding due to low levels of liver dependent coagulation factors. • Individuals who have manifested severe hypersensitivity reactions, including anaphylaxis, to the product or its components. BeneFIX is contraindicated in patients with a known history of hypersensitivity to hamster protein. Risks • Allergic and anaphylactic reactions. • Formation of inhibitors • Rare, but potential thromboembolic complications. Dosage Many Hemophilia patients carry a Factor First card with pertinent information about their prescribed therapy. Consult with the Hematologist-on-call or Bleeding Disorders Clinic Nurse Practitioner for dosing and prescribing guidelines. The nearest combination of whole vials must be used to deliver the prescribed dose. Compatible Solution The manufacturer does not recommend any compatible fluids. TR.05.12 Transfusion Manual 10/05/17 Page 1 of 2 BLOOD PRODUCT FACT SHEET FACTOR IX CONCENTRATE Do not mix with 5% dextrose or other parenteral infusion solutions. Administration Administer the first ten doses of BeneFIX® under direct supervision of RN/NP/MD Encourage patient/caregiver to self-administer the product if they are knowledgeable and able to do so. Visually inspect for particulate matter and discolouration prior to administration Refer to product monograph Administer: • By intravenous injection only • At room temperature • Through a separate injection site • Inject intravenously over several minutes. The rate of administration should be determined by patient’s comfort level. • If giving factor concentrate through a port or indwelling IV catheter: • Flush the line before and after administration with 0.9% Normal Saline only. • If giving factor concentrate via a butterfly infusion set: • It is not necessary to flush; the volume of factor concentrate remaining in the infusion set will not affect treatment. • However, if a decision is made to flush then, flush the line with 0.9% Normal Saline only. Note: Agglutination of red blood cells in the tubing/syringe has been reported with the administration of BeneFIX. No adverse events have been reported in association with this observation. To minimize the possibility of agglutination, it is important to limit the amount of blood entering the tubing. Blood should not enter the syringe. If red blood cell agglutination is observed in the tubing or syringe, discard all material (tubing, syringe and BeneFIX solution) and contact Transfusion Medicine. Infusion Rates BeneFIX: • No mL per minute rate given by manufacturer. • Inject intravenously over several minutes. The rate of administration should be determined by patient’s comfort level. ALPROLIX: • Inject intravenously over approximately 10 minutes. The rate of administration should be determined by the patient’s comfort level. Monitoring Observe patient for signs and symptoms of a transfusion reaction. In the event of a suspected transfusion reaction, refer to Transfusion Reaction Procedure & Reference Guide and complete Transfusion Reaction Report Form. Storage Conditions Stored in a monitored blood product storage refrigerator at 1 – 6 ºC. Home storage may vary and does not apply in the hospital situation. For reconstituted product: • Protect ALPROLIXTM from direct sunlight. • Administer within 3 hours of reconstitution. • Return product and Transfusion Record to Transfusion Medicine within 20 minutes from time of issue if there are any delays in administration. • Do not refrigerate or store on nursing unit. References Product monograph: BeneFIX®, ALPOLIX TR.05.12 Transfusion Manual 10/05/17 Page 2 of 2 .
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