Princess Margaret Hospital for Children Haematology Transfusion Medicine Protocols Factor VIII (8) Plasma Derived Blood Components and Synthetic / Recombinant Products Factor VIII (8) PRODUCT PREPARATIONS Plasma Derived Factor VIII and von Willebrand Factor Biostate® FORMULATIONS Biostate® Product Information Recombinant Factor VIII Xyntha® Xyntha® Product information Advate® Advate® Product Information SPECIFICATIONS Biostate® is a high purity, sterile, powder for injection containing a human coagulation factor VIII (FVIII) and human von Willebrand factor (vWF) complex. Recombinant Factor VIII (Antihemophiliac factor). Does NOT contain von Willebrand Factor. ½ life: 8-12hours ½ life: 8-12 hours Manufactured from pooled human plasma NOTE vials state FVIII and vWF activity: 250 IU FVIII / 500IU vWF (5mL H2O reconstitution) VIAL SIZE 500 IU FVIII / 1000IU vWF (10mL 250, 500, 1000 and 2000 IU H2O reconstitution) 1000 IU FVIII / 2000IU vWF (10mL H2O reconstitution) INDICATIONS Von Willebrand Disease Plasma derived Factor VIII (which contains Factor VIII and von Willebrand Factor) is used for the management of bleeding episodes including surgical and dental procedures in patients with von Willebrand’s disease. Haemophilia A Recombinant Factor VIII is the treatment of choice in the treatment of traumatic and spontaneous bleeds, perioperative management and prevention (prophylaxis) of bleeding in patients with Haemophilia A (Factor VIII deficiency). Page 1 of 5 PRODUCT Plasma Derived Factor VIII and von Willebrand Factor Biostate® is contraindicated in individuals with a history of anaphylactic or severe systemic response to coagulation FVIII and/or vWF preparations. It is contraindicated in individuals with CONTRAINDICATIONS a known hypersensitivity to any of its components. CONSUMER INFORMATION Biostate® Consumer Medicine Information Recombinant Factor VIII Xyntha®: Do not use in patients who have manifested life-threatening immediate hypersensitivity reactions, including anaphylaxis, to the product or its components including hamster proteins. Advate®: Do not use in patients who have life-threatening hypersensitivity reactions, including anaphylaxis, to mouse or hamster protein or other constituents of the product (mannitol, trehalose, sodium chloride, histidine, Tris, calcium chloride, polysorbate 80, and/or glutathione). Xyntha® Consumer Medicine Information Advate® Consumer Medicine Information CONSENT Manufactured from pooled human Written consent is not required. plasma. Written consent to blood products required. Refer to Transfusion Medicine Protocol – Blood product prescription and informed consent. DOSE Requests and dosage of all Factor VIII products must be discussed with the Consultant Haematologist. PRESCRIPTION WARNING Prescriptions for plasma-derived Factor VIII should clearly specify the dose of Factor VIII and von Willebrand Factor, as each vial of Biostate® contains twice as much von Willebrand Factor as Factor VIII and confusion can lead to the wrong dose being given. For example: if 250 IU of Factor VIII is required, the dose should be documented on the medication chart as follows: FVIII 250 IU / vWF 500 IU ORDERING Ordered on a named patient basis from Transfusion Medicine Unit (TMU). For instructions on reconstitution/filtration, refer to the individual product information and other supporting material accompanying the product. Reconstitution Biostate® Reconstitution Guide Xyntha® Reconstitution Guide Advate® Reconstitution Guide Page 2 of 5 Haematology Transfusion Medicine Protocol ADMINISTRATION OBSERVATIONS ADVERSE REACTIONS Two staff to perform checks as per PNPM 2.1.2 for Checking and Administration processes. Check Issue label and patient ID. Check right patient, right product, right dose – prescription matches product supplied. If not identical, contact TMU and prescribing doctor. Verify that the prescription is complete, including clearly stating the type of Factor VIII. Administered IV – either as a bolus dose or continuous infusion. Bolus dose administration – refer to individual product information for appropriate rate. Continuous infusion – administered via an infusion device. Prime line with product. Rate as specified by prescribing medical officer. Do not mix/piggy back this product with other medications or IV fluids/blood products. Bolus doses must be administered under constant visual observation. Vital signs (temperature, pulse, respiration, blood pressure) must be undertaken and recorded on the CEWT chart or in the medical notes. Observe for signs of any adverse reaction and tissue infiltration. Monitor patient for at least 10 minutes post administration. Symptoms may include: skin rash, itching, tightness of throat or chest, shortness of breath, chest pain or wheezing. For more information refer to the Product Information. Adverse reaction should be reported to the Clinical Haematologist and TMU. Refer to Blood Products – Management and Reporting of Reactions and Adverse Effects as a guide to further treatment and management of the patient. Also refer to PNPM 3.11.1 Reporting of Allergies and Adverse Reactions. A record must be kept in the patient’s medical notes of the following The date and time of administration Amount given The batch number and expiry date of each bottle used must be attached to DOCUMENTATION the Blood Product Administration Record/ Transfusion Record MR616 (product has a peel off label with batch number and expiry date on). This information is important should the patient have a reaction or if there is a need to trace recipients of certain batch numbers at a later date. For further information, refer to product insert Return product to TMU immediately if no longer required. Product should be used for intended patient (issue label) only. References Biostate® Product Information Xyntha® Product information Advate® Product Information Page 3 of 5 Haematology Transfusion Medicine Protocol Flippin’ Blood BloodSafe SA / ARCBS Second Edition June 2012 http://resources.transfusion.com.au/cdm/ref/collection/p16691coll1/id/20 Related policies, procedures and guidelines. Transfusion Medicine Protocol, Blood product prescription and informed consent Paediatric Nursing Practice Manual, Section 2.1.2 checking and administration of medications Transfusion Medicine Protocol, Pre transfusion checking procedure Paediatric Nursing Practice Manual, Section 3.1.9 children’s early warning tool Paediatric Nursing Practice Manual, Section 4.1 code blue (55) and emergency resuscitation Transfusion Medicine Protocol, adverse effects of transfusion Paediatric Nursing Practice Manual, Section 3.11.1 reporting of allergies and adverse reactions Useful resources A range of guidelines for use of coagulation factors and management of haemophilia and other bleeding disorders (Australian Haemophilia Centre Directors’ Organisation), are available at www.ahcdo.org.au/publications Page 4 of 5 Haematology Transfusion Medicine Protocol File Name and Path: Document Owner: Reviewer / Team: Document Sponsor: Date First Issued: Last Revised: Endorsed by: Standards Applicable: Factor VIII (8). W:\Executive\PMH\CAHS SQP\Transfusion Coordinator\Protocols\2014\14 Plasma Derived Blood Components & SyntheticRecombinant Products\Monographs\Factor VIII (8) 2015 Monograph FINAL.doc Chair of Patient Blood Management Committee (Dr C Cole) Consultant Haematologist (Dr J Price), Haematology CN (L Lee), Transfusion Coordinator (A Taylor) PMH Patient Blood Management Committee January 2005 Version: 5 February 2015 Review Date: February 2017 th PMH Patient Blood Date: 27 March 2015 Management Committee NSQHS Standards: Page 5 of 5 Haematology Transfusion Medicine Protocol