Consumer medicine information

Obizur 500 U Powder for injection

Susoctocog alfa

BRAND INFORMATION

Brand name

Obizur

Active ingredient

Susoctocog alfa

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Obizur 500 U Powder for injection.

1. Why am I using OBIZUR?


OBIZUR contains the active ingredient susoctocog alfa. OBIZUR is used to treat bleeding episodes in adults with acquired haemophilia A (a bleeding disorder caused by lack of Factor VIII activity due to antibody development against Factor VIII).
For more information, see Section 1. Why am I using OBIZUR? in the full CMI.

2. What should I know before I use OBIZUR?


Do not use if you have ever had an allergic reaction to OBIZUR, or you are allergic to hamster proteins or any of the ingredients listed at the end of the CMI. Do not use if you have congenital haemophilia A with inhibitors (CHAWI).
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use OBIZUR? in the full CMI.

3. What if I am taking other medicines?


There are no known interactions of OBIZUR with other medicines.
For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How will I be given OBIZUR?

  • OBIZUR injection will be prepared and administered by a qualified healthcare professional who is experienced in the care of patients with haemophilia.
  • Your doctor will calculate your dose of OBIZUR depending on your condition and body weight.
  • OBIZUR is given slowly by injection directly into your vein.
  • The frequency of infusions you receive, and the duration of treatment, will depend on how well OBIZUR is working for you.

More instructions can be found in Section 4. How do I use OBIZUR? in the full CMI.

5. What should I know while using OBIZUR?

Things you should do
  • Tell your doctor or healthcare professional straight away if you notice:
  • any sudden signs and symptoms of a severe allergic response, e.g. shortness of breath, wheezing, difficulty breathing; chest pain or discomfort; light headedness, dizziness or fainting; puffiness or swelling of your face, lips, or any other parts of the body; rash, itching or hives on the skin.
  • your bleeding is not controlled or worsens.
Driving or using machines
  • OBIZUR is not expected to have an influence on your ability to drive or use machines.
Looking after your medicine
  • OBIZUR is to be stored at 2°C to 8°C in the refrigerator. Do not freeze.
  • The staff at the hospital and/or Haemophilia Treatment Centre will be responsible for the correct storage of OBIZUR before and during its use.

For more information, see Section 5. What should I know while using OBIZUR? in the full CMI.

6. Are there any side effects?


Development of new antibodies and/or increases in pre-existing inhibitory antibodies against the medicine may occur, and this may result in lack of efficacy with continued bleeding.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

BRAND INFORMATION

Brand name

Obizur

Active ingredient

Susoctocog alfa

Schedule

Unscheduled

 

1 Name of Medicine

Susoctocog alfa (bhk).

2 Qualitative and Quantitative Composition

Each Obizur vial contains nominally 500 units (U) of susoctocog alfa, which is a B domain deleted recombinant derived antihaemophilic factor VIII (rpFVIII), porcine sequence.
After reconstitution, Obizur contains nominally 500 U/mL susoctocog alfa.
Each vial of Obizur is labelled with the actual rpFVIII activity expressed in units determined by a one stage clotting assay, using a reference rpFVIII material calibrated against the World Health Organization (WHO) 8th International Standard for human factor VIII concentrates. The specific activity of Obizur is in the range of 11,000-18,000 units per milligram of protein. The potency values of Obizur determined by the chromogenic assay vary and are approximately 20-50% lower than those of the one-stage clotting assay.
Susoctocog alfa is expressed in a genetically engineered baby hamster kidney (BHK) cell line and secreted into the cell culture medium, and the protein is purified using a series of chromatography and filtration steps. The production process includes two dedicated viral clearance steps - a solvent/detergent treatment step for viral inactivation and a nanofiltration step through a series of two 15 nanometre filters for removal of viruses. No additives of human or animal origin are used in the formulation of Obizur.
Excipient(s) with known effect. Each vial of Obizur contains maximally 4.4 mg (198 mM) sodium per mL of reconstituted solution (see Section 4.4 Special Warnings and Precautions for Use).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Powder and diluent for solution for injection.
Obizur is formulated as a white, sterile, non-pyrogenic, lyophilised powder for intravenous injection after reconstitution with the diluent.
The diluent, water for injections, is a clear and colourless solution, practically free from visible particles.

4 Clinical Particulars

4.9 Overdose

No symptoms of overdose have been reported.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Genotoxicity studies have not been conducted which is acceptable for a biotechnology-derived product such as Obizur.
Carcinogenicity. Carcinogenicity studies have not been conducted which is acceptable for a biotechnology derived product such as Obizur.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Susoctocog alfa is a purified glycoprotein with an approximate molecular weight of 170 kDa, containing a 90 kDa heavy chain and a 80 kDa light chain. The B-domain normally present in naturally occurring porcine factor VIII has been replaced with a twenty-four amino acid linker.
CAS number. 1339940-90-7.

7 Medicine Schedule (Poisons Standard)

Unscheduled (Exempted).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/OBIZURST.gif