Prothrombin Complex Concentrate (PCC) - Octaplex® and Beriplex®
Human Prothrombin Complex
|Alternate Product Name:|
Human Prothrombin Complex, freeze dried powder and solvent for solution for injection
Octapharma Canada Inc.
- A human prothrombin complex concentrate (PCC) containing the coagulation factors II (2), Vii (7), IX (9), and X(10) and Proteins C and S.
- The Octaplex and Beriplex PCC brand name products are considered equivalent in terms of clinical effectiveness
- Vial sizes/dosages:
- Available in two vial sizes containing a lyophilized plasma protein preparation consisting of either approximately 500 units (20 mL vial) or 1000 units (40 mL vial) prothrombin complex (coagulation factors II (2), VII (7), IX (9), X (10)), Protein C and S. See product insert for actual amounts. Factor IX is used to determine the concentration of the product
- Available in one vial size containing a lyophilized plasma protein preparation consisting of approximately 500 units (20 mL vial), prothrombin complex (coagulation factors II (2), VII (7), IX (9), X (10)), Protein C and S. See product insert for actual amounts. Factor IX is used to determine the concentration of the product.
- Supplied by Canadian Blood Services (CBS)
- Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site.
- Urgent reversal of warfarin in patients with an INR of 1.5 or greater with:
- Major bleeding and/or
- Need for an unplanned surgical procedure which cannot be delayed a minimum of 6 hours
Note: The PCC request for warfarin reversal should be based on an INR result that is no more than 2 hours from the time it was reported
- Consideration for management of factor Xa inhibitor (apixaban (Eliquis®)), rivaroxaban (Xarelto®), or edoxaban (Lixiana®) associated bleeding. See "Dosage" and "Administration" sections below and/or consult the Transfusion Medicine Physician on-call - off-label use
- In the absence of Frozen Plasma, consideration may be given to PCC plus Fibrinogen Concentrate dosing, to mitigate bleeding in trauma - off label use
- Hypersensitivity to this product or to any ingredient in the formulation or the container.
- PCCs contain up to 310 units of heparin, and should not be given to patients with a proven history of heparin-induced thrombocytopenia type II or with known allergies to heparin. Even if the antibody against the heparin-protein complex cannot be demonstrated, the administration of PCCs may cause a booster effect with an immediate generation of the antibody.
- Immunoglobulin A (IgA) deficiency, with known antibodies against IgA (applies to Octaplex® only).
- PCC should not be used in patients with recent myocardial infarction, with a high risk of thrombosis or with angina pectoris, with the exception of life-threatening bleeds or the need for emergency surgery in patients on vitamin K antagonists and an INR greater than 3, or an overdose of direct oral anticoagulants
- Due to the pro-coagulant capacity, it is not recommended for bleeding management in disseminated intravascular coagulation (DIC)
- For additional detail, see the Contraindications section of the product monograph
- Hypersensitivity reactions, including anaphylaxis, are possible, should symptoms occur, discontinue treatment and follow adverse even protocol. See Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141
- This product is prepared from large pools of human plasma, which carries the potential (although rare) risk of viral infection. The most responsible healthcare practitioner (MRHP) must discuss the risks and benefits of this product with the patients before it is prescribed or administered
- Appropriate vaccination (ex., hepatitis A and B) is recommended for patients in regular/repeated receipt of human plasma-derived prothrombin complex products
- Treatment with plasma-derived products that contain factors II (2), VII (7), IX (9), and X (10) has been associated with the development of thrombosis and may be associated with an increased risk of DIC and thrombotic complications
- Replacement therapy may rarely lead to the formation of circulating antibodies inhibiting one or more of the human prothrombin complex factors. If such inhibitors occur, the condition will manifest itself as a poor clinical response.
- Dosage is dependent on indication for product:
Urgent/Emergent warfarin reversal
|||INR 1.5 - 2.9||INR 3.0 - 5.0||INR 5.1 or greater|
|PCC dosage||1000 units||2000 units||3000 units|
- Vitamin k 10 mg IV must be given concurrently for warfarin reversal
- If the INR is unknown and major bleeding is present in a patient known to be taking warfarin, 2000 units (80 mL) PCC should be administered
- Maximum dose not to exceed 3000 units
Consult the following document for additional information:
Emergency Reversal of Warfarin Using Prothrombin Complex Concentrates
Urgent/Emergent management of factor Xa inhibitor associated bleeding (off-label):
Beriplex®/Octaplex® 25-50 units/kg x 1
- Maximum dose not to exceed 3000 units
Consult the following document for additional information:
Guidelines for Management of Severe Bleeding Associated with Direct Anticoagulant (DOAC) Agents using Coagulation Factor Concentrates
Massive hemorrhage management in the absence of Frozen Plasma (off-label):
- PCC 2000 units, plus Fibrinogen Concentrate 4 g (if Fibrinogen level unknown or less than 1.5 g/L in a non-obstetrical hemorrhage or less than 2.0 g/L in an obstetrical hemorrhage).
Consult with the Transfusion Medicine Physician on call with questions or dosing recommendations for indications other than those listed by paging through switchboard at (306)655-1000.
|Pre-Administration Testing Requirements|
- The PCC request for warfarin reversal should be based on an INR result that is no more than 2 hours from the time it was reported
- In patients taking factor Xa inhibitor anticoagulation, a baseline INR and Creatinine are recommended
- If the INR is elevated, this suggests that circulating drug is present; however, if the INR is normal, the presence of circulating drug cannot be ruled out. Contact the Transfusion Medicine physician on-call to discuss the potential utility of an anti-Xa level in the perioperative setting
- Factor Xa inhibitors are renally cleared. Renal insufficiency will delay drug clearance.
- As directed by the MRHP
- Specify type of coagulation concentrate and dosage required
- Off label requests must be approved by the Transfusion Medicine Physician on-call, and may be contacted through switchboard at (306) 655-1000
- To request product from the transfusion medicine laboratory used the Plasma Protein Product Request Form #103221
- 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 even occurs)
- Notification of administration of Blood and/or Blood Products Form #103854
- Forms can be located in the Lab Services Manual or Forms on Demand
- Each carton of PCC includes the following:
- A single-use vial of PCC
- A vial with solvent (20 mL or 40 mL based concentration of the vial
- A Mix2Vial™ transfer set with integrated filter
- Additional supplies needed:
- Luer lock syringes (appropriate size based on volume) for administration
- Sterile alcohol swabs (for cleaning the tops of the vials)
- Labels (to affix onto infusion syringe)
- Octaplex®- initial infusion rate of 1 mL/min (Pump rate: 60 mL/h) for first 10 minutes, followed by a maximum rate of 2-3 mL/min (Pump rate: 120-180 mL/h) is recommended by the manufacturer
Note: an administration rate of up to 1000 units in 5 minutes (8 mL/min) is documented to be safe for this product.
- Beriplex® - Maximum rate of 8 mL/min (Pump rate: 480 mL/h) is recommended by the manufacturer
- Options for IV Infusion:
- Direct IV: Slow administration, not to exceed 8 mL/min.
- Syringe pump: microbore tubing required. Not to exceed 2-3 mL/min (pump rate: 180 mL/h)
- SMART pump: select 'blood PCC Octaplex' or 'blood PCC Beriplex'
- Minibag: NOT recommended
- 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 PCC. No other drugs/solutions (including normal saline) can be co-administered in the same line while PCC is being infused
- Preparation and Reconstitution
Note: Reconstitute only immediately before administration
- If it is not administered immediately, the reconstituted solution can be stored for up to 8 hours at +2⁰C to +25⁰C, provided sterility of the stored product is maintained
- DO NOT refrigerate after reconstitution
- DO NOT further dilute in any IV solutions
- DO NOT mix with other drugs or IV solutions
- Protect from exposure to light
- Use aseptic technique (clean and germ free) when preparing and reconstituting Octaplex®
|Allow the vials of PCC powder and diluent to reach room temperature before use. This product is stored at room temperature within the Transfusion Medicine Laboratory. Room temperature diluent helps with dissolving the powder and lessen patient discomfort in the vein when administering|||
|Remove the flip caps from both the PCC vial and the solvent vial. Scrub the rubber stoppers with an alcohol swab for 15 seconds and allow to dry|||
|Peel away the lid of the outer package of the Mix2Vial™ transfer set. Place the solvent vial on an even surface and hold the vial firmly. Take the Mix2Vial™ together with its outer package and invert it over the solvent vial. Push the blue plastic cannula of the Mix2Vial™ firmly through the rubber stopper of the solvent vial (Fig.1).|||
|While holding onto the solvent vial, carefully remove the outer package from the Mix2Vial™, being careful to leave the Mix2Vial™ attached firmly to the solvent vial (Fig.2).|||
|With the PCC vial held firmly on an even surface, quickly invert the solvent vial (with the Mix2Vial™ attached) and push the transparent plastic cannula end of the Mix2Vial™ firmly through the stopper of the PCC vial (Fig.3). The solvent will be drawn into the PCC vial by vacuum|||
|With both vials still attached, slowly (carefully not to introduce bubbles) swirl the PCC vial to ensure the product is fully dissolved, giving a clear or slightly opalescent, colorless or slightly yellow solution. Once the contents of the PCC vial are dissolved, firmly hold both the transparent and blue parts of the Mix2Vial™ . Unscrew the Mix2Vial™ into two separate pieces with the vials still attached (Fig. 4). Discard the empty solvent vial and the blue part of the Mix2Vial™ into a sharps disposal container|||
|Attach a plastic sterile disposable syringe to the transparent part of Mix2Vial™. Invert the system and draw the reconstituted PCC into the syringe. Once the PCC solution has been transferred into the syringe, firmly hold the barrel of the syringe (keeping it face down) and detach the Mix2Vial™ from the syringe. Discard the Mix2Vial™(transparent plastic part) and the empty PCC vial into a sharps disposal container.|||
|Complete patient and product information on the labels provided by Transfusion Medicine and affix to the plastic syringe containing the PCC|||
|Clean the intended injection site with an alcohol swab and attach the luer lock syringe containing the PCC. Administer product|||
- Lab testing post administration: As directed by most responsible healthcare practitioner (MRHP).
- Patient monitoring: Follow the Nursing Policy and Procedure Blood Components and Plasma Protein Product - Administration of #1141
- Documentation: Administration and vital signs shall be recorded on the Transfusion/Infusion Administration and Assessment Record #101059
- See Warnings section above
- 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
- For product education and administration assistance, contact the Transfusion Safety Office at (306) 655-0988, Monday to Friday, 0800-1630
If you choose to print this information, it is valid only on date of print.
Laboratory Controlled Document LSM-342 v11