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Product Catalogue

​NiaStase RT®

Transfusion Medicine

Class:
​epatcog alpha (activated)
Activated Recombinant Human Blood Coagulation Factor VII
Room Temperature Stable
​Alternate Product Name:
Activated Recombinant Factor VII
Company Supplier:​
Novo Nordisk Canada Inc.

​Routes

​Intravenous
​​ ​Other
​Direct IV
​Intermittent IV Infusion
Continuous Infusion​
​Subcutaneous
Intramuscular​
​Other
​Acceptable Routes
​Yes
​No
​Yes * see administration
​No
​No
​N/A


​Description
  • Contains activated recombinant human blood coagulation Factor VII (7) (rFVIIa) (eptacog alfa, activated).
  • Recombinant Factor VII (7) is a vitamin K-dependent glycoprotein consisting of 406 amino acids (MW approximately 50 K Dalton_. which is structurally similar to human plasma-derived Factor VIIa (7a)​
​Availability
  • Vial sizes/dosages:
    • 1 mg is supplied with 1 mL prefilled syringe of solvent
    • 2 mg is supplied with 2 mL prefilled syringe of solvent
    • 5 mg is supplied with 5 mL prefilled syringe of solvent
    • 8 mg is supplied with 8 mL prefilled syringe of solvent
      NOTE: Do not reconstitute with sterile water or other solvents
  • Supplied by Canadian Blood Services (CBS)
  • Contact your local laboratory/transfusion laboratory service regarding in house stock availability at your site​
​Indications
  • ​In hemophilia A/B patients with inhibitors to FVIII (8) or FIX (9), respectively, for the treatment of bleeding episodes (including treatment and prevention of those occurring during and after surgery).
  • For the treatment of severe bleeding episodes in Glanzmann's thrombasthenia with clinical refractoriness and/or platelet-specific antibodies, or where platelets are not immediately available
  • For the prevention of bleeding in surgical interventions or invasive procedures in Glanzmann's thrombasthenia with clinical refactoriness and/or platelet-specific antibodies, or where platelets are not readily available
  • In adult patients with acquired hemophilia, for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures
  • In patients with congenital Factor VII (7) deficiency, for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures
  • 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
  • Patients who do not have hemophilia A (factor VIII (8) deficiency)
  • Known hypersensitivity to the active substance, the excipients or to mouse, hamster or bovine protein
  • For a complete listing, see the contraindications section of the product monograph​
​Warnings
  • Both arterial and venous thromboembolic adverse events have been reported after treatment with rFVIIa, mostly in patients with predisposing concurrent risk factors
  • Simultaneous use of prothrombin complex concentrates, activated or not, should be avoided
  • Reports of fatal and non-fatal outcomes, including those associated with thromboembolic events have been received during off-label use
  • Patients with inherent Factor VII (7) deficiency may have pre-existing or may develop antifactor VII (7) antibodies
  • 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

​Dosage
  • Should be determined by a physician experienced in the care of bleeding disorder patients
  • For further information about dosage, please review the product monograph
  • The recommended dose range, dose, frequency, and duration of NiaStase RT® administration as a single agent are dependent on the indication that it's being used for. It may be administered every 2 hours until clinical improvement is observed. If continued therapy is required, the dosage interval may be increased from 2 to 6 hours depending on the period of time the treatment is judged to be indicated
  • Consult with a Hematologist or the Saskatchewan Bleeding Disorder Program for safe dosing recommendations by paging 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 disorder 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
  • 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)
  • Forms can be located in the Lab Service Manual or Forms on Demand​
​Supplies Required
  • Each carton of NiaStase RT® includes the following:
    • A single-use vial of NiaStase RT® powder
    • A prefilled diluent syringe containing sterile water for injection
    • A vial adaptor (transfer device)
    • one plunger rod (placed under the syringe)
    • One butterfly infusion set (can use if patient does not have an IV in place)
  • Additional supplies needed:
    • One butterfly infusion set (can use if patient does not have an IV in place)
    • One luer lock syringe (appropriate size based on volume) for administration
    • Sterile alcohol swabs (for cleaning the tops of the vials)
​Administration
  • Blood consent: is NOT required as NiaStase RT® is NOT manufactured from human plasma
  • 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 slowly over 2 to 5 minutes
    * Continuous infusion may be indicated during the surgical setting with congenital Hemophilia A/B patients with inhibitors. The MHRP will be responsible for ordering the appropriate rate

  • 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 the NiaStase RT®. No other drugs/solutions (including normal saline) can be co-administered in the same line while NiaStase RT® is being infused

  • Preparation and Reconstitution
    NOTE: Reconstitute only immediately before administration
    • Administer as soon as possible, if you cannot use the reconstituted NiaStase RT® solution immediately, it should be kept in the vial (with the vial adapter and the syringe still attached) and stored at room temperature (below 25°C) for no longer than 6 hours or refrigerated (2°C to 8°C) for no longer than 24 hours
    • 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 NiaStase RT®

Bring the vial and the prefilled syringe to room temperature (not above 37°C). You can do this by holding them in your hands until they feel as warm as your hands

​Remove the plastic cap from the vial. If the plastic cap is loose or missing, do not use the vial
​Wipe the rubber stopper with a sterile alcohols swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible
​Remove the protective paper from the vial adapter. If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Do not take the vial adapter out of the protective cap with your fingers. if you touch the spike on the vial adapter, germs from your fingers can be transferred
NiaStase RT Fig A.gif
​Place the concentrate vial on a flat and solid surface. Turn over the protective cap and place the vial adaptor over the center of the rubber stopper of the concentration vial. Press down firmly on the adaptor package until the adaptor spike penetrates the rubber stopper. The adaptor snaps onto the vial when done.
NiaStase RT Fig B.gif
​Grasp the plunger rod by the wide top end and take it out of the carton and avoid contact with the shaft. Attach the threaded end of the plunger rod to the diluent syringe plunger. Turn clockwise until a slight resistance is felt.

NOTE: Do not reconstitute with anything other than the provided diluent
NiaStase RT Fig C.gif
​Remove the tamper-proof plastic tip from the prefilled syringe by bending it down until the perforation breaks, Do not touch the syringe tip under the syringe cap
NiaStase RT Fig D.gif
​Remove the adaptor packaging and discard. Firmly connect the diluent syringe to the vial adaptor by turning clockwise until resistance is felt
NiaStase RT Fig E.gif
​Slowly inject all solvent into the concentrate vial by pressing down on the plunger
NiaStase RT Fig F.gif
​Without removing the syringe, dissolve the concentrate powder by gently moving or swirling the vial in circles a few times. DO NOT SHAKE
NiaStase RT Fig G.gif
​Inspect the solution for particles. Do not use solutions that are cloudy or have deposits. Since the glass diluent syringes are not compatible with the needleless system (tip too short to activate system), remove the diluent syringe from the vial adaptor, leaving the vial adaptor attached to the vial. Quickly attach a separate luer-lock syringe and draw back the reconstituted contents. Make sure the entire content of the vial is transferred to the syringe
NiaStase RT Fig H.gif
​Detach the filled syringe from the vial adaptor by turning clockwise and discard the empty vial.
NiaStase RT Fig I.gif

  • Lab testing post administration: As directed by most responsible physician (MRP)
​Nursing Implications
​Adverse Events
​Comments
  • Can contact the Saskatchewan Bleeding Disorders Program for 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-1022 v1

Last Modified: Monday, May 11, 2020 |
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