Consumer Information for: NIASTASE RT

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

NiaStase RT® or eptacog alfa (activated) is more commonly known as activated recombinant human blood coagulation Factor VII (rFVIIa). NiaStase RT® is a clotting factor produced using recombinant DNA technology. NiaStase RT® or rFVIIa is free of all human plasma components, eliminating any possibility of contamination through the blood.

NiaStase RT® is used:

  • In hemophilia A and hemophilia B patients with inhibitors to FVIII or FIX, respectively, for the treatment of bleeding episodes (including treatment and prevention of those occurring during and after surgery).
  • To treat bleeding episodes, or prevent bleeds during surgery, in patients with Glanzmann’s thrombasthenia (a bleeding disorder) when platelet transfusions are no longer effective or when platelets are not 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 deficiency, for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures.
What it does

NiaStase RT® is a medicine that works by activating the clotting system in the blood at the site of bleeding to prevent or eliminate the bleeding.

When it should not be used

Pregnancy and breastfeeding
Remember to tell your doctor or nurse if you are pregnant or are breastfeeding. Women of child-bearing potential should avoid becoming pregnant during treatment. Nursing mothers should discontinue nursing during treatment.

DO NOT use NiaStase RT® with any other clotting products. However, your doctor may prescribe other therapies to be used at the same time as NiaStase RT®.

What the medicinal ingredient is

Eptacog alfa, activated, contains activated recombinant human blood coagulation Factor VII (rFVIIa), which is similar to the natural human clotting Factor VIIa.

What the non-medicinal ingredients are

NiaStase RT® contains the following nonmedicinal ingredients: calcium chloride dihydrate, glycylglycine, mannitol, methionine, polysorbate 80, sodium chloride and sucrose.

The solvent for reconstitution that comes with NiaStase RT® contains histidine in water for injections.

What dosage form it comes in

NiaStase RT® comes as a freeze-dried powder available in 1.0 mg (50 KIU), 2.0 mg (100 KIU), 5.0 mg (250 KIU), and 8.0 mg (400 KIU) vials. The freeze-dried powder in a vial is reconstituted (dissolved) with the histidine solvent that is supplied with your NiaStase RT®.

Warnings and precautions

Serious Warnings and Precautions

  • The extent of the risk of developing blood clots after using NiaStase RT® is not known but is considered to be low. You may have an increased risk of developing blood clots if you have experienced a crush injury, have infection of the blood, hardening of the arteries or if you are prone to develop blood clots. If so, contact your Hemophilia Care Centre or doctor.
  • Patients that lack the blood clotting factor VII (known as factor VII deficiency) can have an allergic response to NiaStase RT®.

BEFORE you use NiaStase RT® talk to your doctor if:

  • you have experienced a crush injury;
  • you have infection of the blood;
  • you have hardening of the arteries;
  • you are prone to develop blood clots.

This information will help your doctor and you decide whether you should use NiaStase RT® and what extra care may need to be taken while you are on the medication.

Interactions with this medication

Tell your doctor if you are taking, have recently taken or might take any other medicines.

Do not use NiaStase RT® at the same time as prothrombin complex concentrates or recombinant Factor XIII.

You should talk to your doctor before using NiaStase RT® if you also use Factor VIII or IX products.

There is limited experience of using NiaStase RT® together with medicines called antifibrinolytic drugs (such as tranexamic acid) which are also used to control bleeding. You should talk to your doctor before using NiaStase RT® with these medicines.

Interactions with other drugs have not been established.

Before using NiaStase RT®, talk to your doctor about any medicine you use.

Proper use of this medication

NiaStase RT® is available in four different strengths. Always check that you have the strength prescribed by your doctor. Always use an aseptic technique when injecting NiaStase RT®.

For instructions on how to prepare and administer NiaStase RT® please refer to the end of this leaflet.

Side effects and what to do about them

Unwanted effects are possible with all medicines. Tell your Hemophilia Care Centre or doctor as soon as possible if you do not feel well while you are receiving treatment with NiaStase RT®.

You may experience some redness at the injection site. This is normal. However, if you develop more severe symptoms such as: hives, itching, tightness of the chest, wheezing, or any other unusual effects, you should contact your Hemophilia Care Centre or doctor immediately.

Isolated cases of hypersensitivity reactions including anaphylactic reactions have been reported. Remind your doctor if you have a history of allergic reactions as you may need to be monitored more carefully.

Seek medical attention without delay, if bleeding does not appear to be adequately responding to treatment.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or Hemophilia Care Centre Only if severe Talk with your doctor or Hemophilia Care Centre In all cases Stop taking drug and call your doctor
Common
Redness at injection site ✔    
Uncommon
Hives   ✔  
Itching   ✔  
Tightness of chest     ✔
Wheezing     ✔
Unusual effects   ✔  
If bleeding does not stop   ✔  

This is not a complete list of side effects. For any unexpected effects while taking NiaStase RT®, contact your doctor.
How to store

Prior to reconstitution, keep NiaStase RT® powder and histidine solvent refrigerated or store between 2° to 25°C. Do not freeze.
Protect powder and solvent from light. Do not use past the expiration date on the label.

After reconstitution, NiaStase RT® should be used immediately. If you do not use immediately after mixing, NiaStase RT® may be stored either at room temperature (below 25°C) or refrigerated for up to 3 hours. Do not freeze or store reconstituted NiaStase RT® in syringes.

Keep all medication and supplies out of the reach of children.

Reporting side effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:

  • Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Patient Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 1908C
      Ottawa, ON
      K1A 0K9
    Postage paid labels and the Patient Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

More information

If you still have questions or would like more information, please contact your doctor or Hemophilia Care Centre.

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.novonordisk.ca or by contacting Novo Nordisk Canada Inc., at: 1-800-465-4334

This leaflet was prepared by Novo Nordisk Canada Inc.

NiaStase RT® is a registered trademark of Novo Nordisk Health Care AG and is used under license by Novo Nordisk Canada Inc. MixPro® is a registered trademark of Novo Nordisk A/S and is used under license by Novo Nordisk Canada Inc.

© 2017
Novo Nordisk Canada Inc.

Last revised: November 6, 2017

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