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Obizur: Uses, Side Effects and Dosage

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

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

What is OBIZUR used for?

  • Treatment of bleeding episodes in patients with Acquired Hemophilia A.

How does OBIZUR work?

OBIZUR temporarily replaces the inhibited human clotting factor VIII that is needed for effective hemostasis.

What are the ingredients in OBIZUR?

Medicinal ingredients: Recombinant porcine factor VIII.

Non-medicinal ingredients: Calcium chloride, Polysorbate 80, Sodium chloride, Sucrose, Tris, Tri-sodium citrate.

OBIZUR comes in the following dosage form:

Powder for Solution for Injection / 500 Units per mL reconstituted with 1 mL of sterile water for injection for intravenous use.

Do not use OBIZUR if:

  • You have a known major sensitivity or allergy to therapeutic products of porcine or hamster origin
  • You have congenital haemophilia A with inhibitors (CHAWI)

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take OBIZUR. Talk about any health conditions or problems you may have, including if you:

  • have prior history of bleeding disorder other than Acquired Hemophilia A
  • have an established reason for bleeding that is not correctable
  • have a known major sensitivity or allergy to therapeutic products of porcine or hamster origin
  • have been treated with hemophilia medication within 3 hours before OBIZUR medication

  • are breastfeeding. It is not known if OBIZUR passes into your milk and if it can harm your baby

  • are pregnant or planning to become pregnant. It is not known if OBIZUR may harm your unborn baby

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with OBIZUR:

There are no known interactions of OBIZUR with other medicines.

How to take OBIZUR:

This product should be administered by your doctor only.

Usual dose:

Your doctor will determine the dose of OBIZUR you will receive.

The dose and frequency of infusions you receive will be based on your measured factor VIII levels and your clinical response.

Overdose:

No symptoms of overdosage of overdose have been reported.

If you think you, or a person you are caring for, have taken too much OBIZUR contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.

Missed Dose:

Dosing is under the discretion of the doctor and patient specific. Please consult the Product Monograph for further details.

What are possible side effects from using OBIZUR?

These are not all the possible side effects you may have when taking OBIZUR.

New or increase in existing inhibitory antibodies to OBIZUR may develop.

Allergic reactions may occur with OBIZUR. Call your doctor or get emergency treatment right away if you get a rash or hives, itching, tightness of the throat, chest pain or tightness, difficulty breathing, light headedness, dizziness, nausea or fainting.

Some common side effects of OBIZUR include constipation, low blood iron levels, low blood potassium levels, diarrhea and a positive anti-porcine inhibitor test result.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

  • Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
  • Calling toll-free at 1-866-234-2345.

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.

Storage:

This product is to be stored and administered by a health professional only.

If you want more information about OBIZUR:

  • Talk to your healthcare professional
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website; https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html, the manufacturer’s website www.takeda.com/en-ca/obizurpm or by calling 1-800-268-2772.

Takeda Canada Inc.

22 Adelaide Street West, Suite 3800

Toronto Ontario M5H 4E3

Last Revised: MAR 9, 2023

OBIZUR® is a registered trademark of Baxalta Incorporated.

TAKEDATM is a trademark of Takeda Pharmaceutical Company Limited, used under license.

About this document

Source: Health Canada – Drug Product Database (DPD) and product monographs · DIN (Drug Identification Number): 02447401

Revision date stated in the text: March 9, 2023

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 Obizur

DIN 02447401
Schedule(s) SCHEDULE D
Active ingredient(s) Antihemophilic factor (recombinant) porcine sequence 500 UNIT
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. B02BD02 Coagulation factor VIII
Company TAKEDA CANADA INC
Current status Marketed
Current status date June 8, 2021

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.