Product Administration Guidelines Humate-P

Name of Product: HUMATE-P® Other names: Anti-hemophiliac factor / von Willebrand Factor Complex (Human) Classification: Coagulation Factor Manufacturer: CSL Behring This is a reference tool only. For complete instructions, please refer to product monograph DESCRIPTION OF PRODUCT HUMATE-P® is a sterile, lyophilized concentrate of Antihemophillic factor and von Willebrand factor (vWF) Contains human plasma. INDICATIONS FOR USE Adult patients - for treatment and prevention of bleeding in hemophilia A (classical hemophilia) Adult and pediatric patients - treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease (VWD), and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate To prevent excessive bleeding (i.e. bleeding that exceeds the expected blood loss under a given condition) during and after surgery in adult and pediatric patients CONTRAINDICATIONS Previous life threatening hypersensitive reactions or anaphylaxis to Humate P ®. WARNINGS Thromboembolic events have been reported in vWD patients receiving coagulation factor replacement therapy. It is not known whether HUMATE-P® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized, HUMATE-P® is made from human plasma. Products made from large pools of human plasma may contain infectious agents, including the causative agents of hepatitis and other viruses that can cause disease. DOSAGE Consult the Bleeding Disorders Clinic or the Hematologist on call for appropriate dosing and prior to initial dose: (Adult) Hereditary Bleeding Disorder Clinic – 473-5612 After hours call 473-2220 Fax 902-473-7596 (Pediatric) IWK Bleeding Disorder Clinic – 470-8752 After hours call 1-888-470-8888 Fax 902-470-7208 Ask patient if they have a Factor First Card supplying the recommended treatment and dosage. ADULT Dose: loading dose given with additional subsequent doses every 8-12 hours to achieve trough levels above 50%. Can be given up to 7 days, Dosing for VWD and hemophilia A vary for the specific indication. Refer to dosing recommendations as per manufacturer. HUMATE-P® is labeled in both Factor VIII (8) units and von Willebrand Factor (vWF): Ristocetin Cofactor International Units (RCof IU). 1 Product Administration Guidelines – Humate-P® 2019 PEDIATRIC Pediatric dosing will vary. For patient specific dosing at the IWK please see Complex Care Management Plan in the “Alerts” section under “Scanned Permanent Health Records” in the IWK MEDITECH MAGIC system Dosage should be ordered and administered as a complete vial. ADMINISTRATION Intravenous Other Direct IV IV Infusion Continuous Infusion Subcutaneous IM Other Routes Yes Yes No No No N/A Pre-Infusion: Ensure patient consent has been obtained prior to requesting blood product from lab/transfusion service where possible. Perform the appropriate pre-transfusion checks per protocol. Access: HUMATE-P® can be given via CVC, PICC, Port-a-Cath®, or peripheral IV line Reconstitution Supplies: All supplies for administration are included with the product HUMATE-P®, lyophilized, single dose vial butterfly infusion set Diluent vial (Sterile water) alcohol swab Mix2Vial™ filter transfer set Sterile Luer lock syringe (large enough to fit multivial dose) Reconstitution: Refer to product monograph: http://labeling.cslbehring.ca/PM/CA/Humate-P/EN/Humate-P-Product- Monograph.pdf Administration Notes: Administer direct IV. Do not exceed 4mL/min. DO NOT further dilute in any IV solutions. Inspect visually for particulate matter and discoloration prior to administration. The solution should be clear or slightly opalescent. Once reconstituted, Humate-P® must be administered within 3 hours at room temperature. DO NOT refrigerate after reconstitution. Protein solutions of this type tend to adhere to the ground glass surface of all-glass syringes. NURSING IMPLICATIONS Vital Signs: Remain with the patient during administration, assess patient and obtain vital signs immediately before and following administration per NSHA/IWK policy. POTENTIAL HAZARDS OF IV ADMINISTRATION Adverse reactions may include: Allergic-type hypersensitivity reactions including anaphylaxis have been reported and have manifested as pruritus, rash, urticaria, local site reactions, hives, facial swelling, dizziness, hypotension, nausea, chest discomfort, cough, dyspnea, wheezing, flushing, discomfort (generalized) and fatigue. Report any adverse reaction to Blood Transfusion Service. AVAILABILITY International Units von Willebrand Factor FVIII:C OR Ristocetin Cofactor International Units vWF:RCof. Supplied by CBS in vials of 1000 and 2000 RCof IU. 2 Product Administration Guidelines – Humate-P® 2019 Contact your local laboratory/transfusion service regarding stock availability on site. STORAGE & STABILITY OF PRODUCT Stored at up to 25 C. Do not freeze. Do not use after the manufacturer’s expiry date. MISCELLANEOUS Latex Free REFERENCES 1. CSL Behring Canada, Inc. (2017). Humate-P® Antihemophilic Factor/vonWillebrand Complex (Human) Product Monograph. Ottawa, Canada. 2. Nova Scotia Bleeding Disorder Clinics. MANUFACTURER CONTACT INFORMATION CSL Behring Canada 1-613-783-1892 - www.cslbehring.ca 3 Product Administration Guidelines – Humate-P® 2019 .

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