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Niastase: Uses, Side Effects and Dosage

Updated:
Facts
Status:
Current status: Cancelled Post Market
Strength:
1.2 mg, 2.4 mg, 4.8 mg
Active ingredient:
ATC code:
Similar drugs:

Source: Health Canada – Drug Product Database (DPD) and product monographs · About this document

Patient Medication Information: uses, side effects, how to take - Niastase

ABOUT THIS MEDICATION

What the medication is used for:

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

What it does:

NiaStase® 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® with any other clotting products. However, your doctor may prescribe other therapies to be used at the same time as NiaStase®.

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 important nonmedicinal ingredients are:

calcium chloride dihydrate, glycylglycine, mannitol, polysorbate 80, sodium chloride.

What dosage forms it comes in:

NiaStase® as a freeze-dried powder is available in 1.2 mg (60 KIU), 2.4 mg (120 KIU) and 4.8 mg (240 KIU) vials. The freeze-dried powder in a vial is reconstituted (dissolved) with Sterile Water for Injection, USP.

WARNINGS AND PRECAUTIONS

Serious Warnings and Precautions

  • The extent of the risk of developing blood

clots after using NiaStase® 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®.

BEFORE you use NiaStase® talk to your doctor 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.

INTERACTIONS WITH THIS MEDICATION

EDICATION

Interactions with other drugs have not been established. Before using NiaStase®, talk to your doctor about any medicine you use.

PROPER USE OF THIS MEDICATION

NiaStase® is available in three different strengths. Always check that you have the strength prescribed by your doctor. Always use an aseptic technique when injecting NiaStase®. For example follow the instructions for ‘Preparing your injection’ and ‘Giving your injection’. Bring the NiaStase® powder and the correct volume of diluent (Sterile Water for Injection, USP - without preservative) to room temperature but not above 37°C (98.6°F). You can do this by holding the vials in your hands for a few minutes.

The correct volume of diluent (Sterile Water for Injection, USP - without preservative) corresponding to each strength of NiaStase® is as follows:

  • 1.2 mg (60 KIU) per vial add 2.2 mL

    Sterile Water for Injection, USP

  • 2.4 mg (120 KIU) per vial add 4.3 mL

    Sterile Water for Injection, USP

  • 4.8 mg (240 KIU) per vial add 8.5 mL

    Sterile Water for Injection, USP

Preparing your injection

  1. 1. Wash your hands with soap and water before beginning.
  2. 2. Hold vials to bring contents to room temperature.
  3. 3.

    Remove the caps, clean stoppers with an alcohol swab, and allow to dry prior to use.

  4. 4. Attach needle to a sterile syringe and remove needle cap.
  1. 5.

    Admit air into the syringe and inject it

    into the vial containing the Sterile Water for Injection.

  2. 6.

    Withdraw the water and inject it into the

    vial containing the powder.

  3. 7.

    Gently swirl the vial until contents

    dissolve into a colourless solution. Do not shake the vial as this will cause foaming.

  4. 8.

    Inspect the vial solution for particles or

    discolouration. If the mixture is discoloured or contains particles, do not use it. Call your Hemophilia Care Centre or doctor.

    Giving your injection

    1. 9.

      Inject NiaStase® as instructed by your

      Hemophilia Care Centre or doctor. Do not store reconstituted NiaStase® in syringes. Use the reconstituted product within 3 hours.

    2. 10. Discard unused solution and needles in a proper container.

SIDE EFFECTS AND WHAT TO DO

ABOUT THEM

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

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

Stop

taking the

drug

and

call

your

doctor

Only if severeIn all cases
Common

Redness at the

injection site

9

Un

common

Hives9
Itching9

Tightness of the

chest

9
Wheezing9
Unusual effects9

If

bleeding does not stop

9

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

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.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll- free telephone: 1-866-234-2345 Toll-free fax: 1-866-678-6789

By e-mail: cadrmp@hc-sc.gc.ca

By regular mail:

National AR Centre

Marketed Health Products Safety and Effectiveness Information Division Marketed Health Products Directorate Tunney’s Pasture, AL 0701C

Ottawa, ON K1A 0K9

NOTE: Before contacting Health Canada, you should contact your physician or Hemophilia Care Centre.

HOW TO STORE IT

Keep NiaStase® refrigerated, do not allow it to freeze.

Store in original package in order to protect from light.

Use each vial of reconstituted NiaStase® within 3 hours of mixing.

Do not use NiaStase® after the expiration date printed on the outer carton and on the vial label.

Do not store reconstituted NiaStase® in syringes.

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

MORE INFORMATION

For further information, please refer to the leaflet ‘Health Professional Information’.

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

This document plus the full product monograph, prepared for health

professionals, is available by contacting the sponsor, Novo Nordisk Canada Inc., at 1-800-465-4334

Last revised: April 2007

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02239659

Revision date stated in the text: April 2007

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Niastase

DIN 02239659, 02239660, 02239661
Schedule(s) SCHEDULE D
Active ingredient(s) Eptacog alfa (activated)
Dosage form(s) Powder For Solution
Route(s) of administration Intravenous
Drug class (WHO ATC)
  1. B Blood and blood forming organ drugs
    1. B02 Antihemorrhagics
      1. B02B Vitamin K and other hemostatics
        1. B02BD Blood coagulation factors
          1. B02BD08 COAGULATION FACTOR VIIa
Company NOVO NORDISK CANADA INC
Current status Cancelled Post Market
Current status date July 22, 2013
Strengths and forms
DIN Strength Dosage form(s) Current status
02239659 1.2 MG Powder For Solution Cancelled Post Market July 22, 2013
02239660 2.4 MG Powder For Solution Cancelled Post Market July 22, 2013
02239661 4.8 MG Powder For Solution Cancelled Post Market July 22, 2013

Source: Health Canada – Drug Product Database (DPD) and product monographs, data as of November 1, 2026. Data from the Health Canada Drug Product Database, as published there. Not a substitute for the advice of a doctor or pharmacist.