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Product Catalogue

​Humate P®

Transfusion Medicine

Class:
Antihemophilic factor/Von Willebrand factor, derived from human plasma
Alternate Product Name:
Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized
​Company/Supplier:
CSL Behring Canada, Inc.
Routes
Intravenous
Other
​Direct IV
​Intermittent IV Infusion
​Continuous Infusion
​Subcutaneous
Intramuscular​
Other​
Acceptable Routes
​Yes
​No
No
No
No
N/A​


Description
  • Humate-P® is a stable, purified, sterile, lyophilized concentrate of Antihemophilic Factor (Human) and von Willebrandt Factor ( vWF) (Human) for intravenous administration in the treatment of patients with classical hemophilia (hemophilia A) and von Willebrand disease (VWD)
  • Each vial of Humate-P® contains the labeled amount of Factor VIII (8) activity in units for the treatment of hemophilia A. Additionally; each vial of Humate-P® also contains vWF:RCof activity in IU for the treatment of VWD
  • VWF:FVIII ratio 2.4:1​
Availability
  • Vial sizes/dosages:
    • (500) units FVIII (8)/(~1200) units VWF RCof, (known as 1000 units of RCof vial reconstituted with 10 mL diluent
    • (1000) units FVIII (8)/(~2400) units VWF RCof, (known as 2000 units RCof vial reconstituted with 15 mL diluent
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site
Indications
  • Hemophilia A: Treatment and prevention of bleeding in Hemophilia A in adult patients
  • Von Willebrand Disease (VWD):
    • In patients of all ages, treatment of spontaneous and trauma induced bleeding episodes in severe von Willebrand disease, and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate. In patients of all ages, to prevent excessive bleeding (i.e. bleeding that exceeds the expected blood loss under a given condition) during and after surgery
  • Treatment should be initiated and supervised by a healthcare practitioner experienced in the use of coagulation agents and in the management of bleeding disorders
Contraindications
  • Known life-threatening allergic reaction, including anaphylaxis to constituents of the preparation
  • For a complete listing, see the contraindications section of product monograph
Warnings
  • Hypersensitivity reactions, including anaphylaxis, are possible. Should symptoms occur, discontinue treatment and follow adverse event protocol. See Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141
  • Serious thromboembolic events have been reported in patients with von Willebrand disease who are treated with coagulation factor replacement therapy. (see WARNINGS AND PRECAUTIONS AND ADVERSE EVENTS in product monograph)
  • Development of factor VIII (8) neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII (8) activity levels are not attained, or if bleeding is not controlled with an appropriate dose, an assay that measures factor VIII (8) inhibitor concentration should be performed. A physician experienced in the care of bleeding disorder patients should be consulted in the case of a suspected factor V111 (8) inhibitor
  • This product is prepared from large pools of human plasma, which may contain the causative agents of hepatitis and other viral diseases. The physician should discuss the risks and benefits of this product with the patient before prescribing or administering to the patient
​Dosage
  • ​Dosage should be determined by a physician experienced in the care of bleeding disorder patients
  • Therapy for Hemophilia A: Dosage must be individualized based on patient specific factors i.e. weight, severity of hemorrhage, presence of inhibitors. Dosing is calculated as FVIII (8) units
  • Therapy for von Willebrand Disease: Dosage must be individualized based on patient-specific factors i.e. weight, vWF RCof levels, and severity of hemorrhage. Dosing is calculated as vWF RCof units
  • For further information about dosage please review the product monograph
  • individual dosing may vary based on the based-on body weight, laboratory values, and the patient's clinical condition
  • Consult with Hematologist or the Saskatchewan Bleeding Disorder Program for safe dosing recommendations, available through switchboard at (306)655-1000
Pre-Administration Testing Requirements
Ordering
  • Specify type of coagulation concentrate and dosage required
  • Off label requests for anyone other than bleeding disorders patients must be approved by the Transfusion Medicine Physician, available through switchboard at (306)655-1000
  • To request product from the transfusion medicine laboratory, use the Plasma Protein Product Request Form #103221​
Forms Required
  • Informed Consent for Blood Components and/or Plasma Protein Products #101479
  • Plasma Protein Product Request Form #103221
  • Transfusion/Infusion Administration and Assessment Record #101059
  • Saskatchewan Transfusion Adverse Event Report Form #103695 (only needed if adverse event occurs)
  • Notification of Administration of Blood and/or Blood Products Form #103854​
​Supplies Required
  • The product package contains:
    • One single-use Humate-P® vial
    • One single-use sterile water for injection vial
    • A needle-less filter transfer device called Mix2Vial for the reconstitution and withdrawal of the product
  • Additional supplies needed:
    • One luer lock syringe (appropriate size based on volume) for administration
    • Alcohol swab (for cleaning the tops of the vials)
Administration
  • Blood Consent: Is required due to human plasma component
  • Pre-Infusion: Ensure recent patient weight is on file and pertinent laboratory results are available
  • Perform all other appropriate pre-administration checks per protocol, detailed in the Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141​

  • Administration:
    Administer the entire dose by slow intravenous injection at a rate not exceeding 4 mL per minute

  • For additional preparation/reconstitution and administration steps see administration section of the product monograph
  • Access: can be given via CVC, PICC, Port-a-Cath, or peripheral IV
  • Compatible Solutions: can flush line with 0.9% normal saline pre and post administration of Humate-P®. No other drugs/solutions (including normal saline) can be co-administered in the same line while Humate-P® is being infused

  • Preparation and Reconstitution
    Note: Reconstitute only immediately before administration
    • Administer within 3 hours after reconstitution
    • DO NOT refrigerate after reconstitution
    • DO NOT further dilute in any IV solutions
    • DO NOT mix with other drugs or IV solutions
Use aseptic technique (clean and germ free) when preparing and reconstituting Humate-P®
​Allow the vials of Humate-P® and diluent to reach room temperature before use. This can be done by warming of both unopened vials in your hands to a comfortable temperature or by leaving the unopened vials at room temperature for about half an hour prior to administration. Warming of the vials will ease with dissolving the powder and lessen patient discomfort in the vein when administering

​Place the Humate-P® vial, diluent vial and Mix2Vial® transfer set on a flat surface

​Remove Humate-P® vial and diluent vial flip caps and wipe the stoppers with an antiseptic. Allow to dry prior to opening the Mix2Vial® transfer set package.

​Open the Mix2Vial transfer set package by peeling away the lid (Fig. 1). To maintain sterility, leave the Mix2Vial® transfer set in its clear outer package
HumateP Figure 1.gif
​Place the diluent vial on an even flat surface and hold the vial tightly. Grip the Mix2Vial® transfer set keeping it in the clear package and push the plastic spike of the blue end of the Mix2Vial® transfer set firmly through the center of the diluent vial stopper (Fig. 2)
HumateP Figure 2.gif
​While holding the diluent vial, carefully remove the outer package from the Mix2Vial® transfer set. Make sure to pull off only the clear package, not the Mix2Vial® transfer set
HumateP Figure 3.gif
​Place the Humate-P® vial on an even flat surface and hold the vial tight. Invert the diluent vial with the Mix2Vial® transfer set attached to it and push the plastic spike of the clear end of the Mix2Vial® firmly through the center of the stopper of the Humate-P® vial (Fig. 4). The diluent will transfer into the Humate-P® vial automatically
HumateP Figure 4.gif
​With the diluent and Humate-P® vial still attached to the Mix2Vial® transfer set, gently swirl the Humate-P® vial to ensure that the Humate-P® is fully dissolved (Fig. 5). Do not shake the vial
HumateP Figure 5.gif
​With one hand, grip the clear end of the Mix2Vial® transfer set and with the other hand grip the blue end of the Mix2Vial® transfer set, and unscrew counter clockwise the set into two pieces (Fig. 6)
HumateP Figure 6.gif
​Draw air into an empty, sterile syringe. With the Humate-P® vial upright, screw the syringe to the Mix2Vial® transfer set. Inject air into the Humate-P® vial and draw the solution into the syringe by pulling the plunger back slowly. (Fig. 7)
HumateP Figure 7.gif
​Once the solution has been transferred into the syringe, firmly grip the barrel of the syringe (keeping the plunger facing down) and unscrew the syringe counter clockwise from the Mix2Vial® transfer set (Fig. 8). Attach the syringe to an infusion set or another suitable administration set

​If patient is to receive more than one vial, the contents of multiple vials may be pooled into a single syringe. Use a separate unused Mix2Vial® transfer set for each product vial
  • Lab testing post administration: as directed by most responsible healthcare practitioner (MRHP)
​Nursing Implications
Adverse Events
  • Allergic reactions are possible with administration of blood components and plasma protein products ranging from mild to life threatening
  • Refer to Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141 for managing of allergic transfusion reaction and call MRHP
  • Document adverse event on Saskatchewan Transfusion Adverse Event Report Form #103695, Whether or not the transfusion was discontinued​
Comments
  • Contact the Saskatchewan Bleeding Disorders Program for further education and administration assistance at (306)381-4185, Monday to Friday, 0800-1630​
References

If you choose to print this information, it is valid only on date of print.

Laboratory Controlled Document LSM-1018 v1

Last Modified: Monday, April 27, 2020 |
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