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).
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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
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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
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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
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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:
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Haematology Transfusion Medicine Protocol