On 19 May 2022 the National Blood Authority announced that five of Australia’s domestic plasma products will be changing.
Will this product change affect me?
The following products are being replaced during calendar years 2023 and 2024:
- INTRAGAM 10 (10% intravenous immunoglobulin)
- EVOGAM (16% subcutaneous immunoglobulin)
- ALBUMEX 4 (4% albumin)
- ALBUMEX 20 (20% albumin)
- PROTHROMBINEX-VF (prothrombin complex concentrate containing clotting factors II, IX and X)
What are the new products?
Some information on the replacement products which are undergoing registration with the Therapeutic Goods Administration (TGA) is in the table below. CSL Behring is developing educational material that will be made available on their website as this registration process is completed for each product. The Additional Resource section below will be updated with links to this material as it becomes available.
The products are clinically comparable to the current products and are assessed by the TGA in accordance with the usual high standards of safety and effectiveness.
Summary of product changes (subject to TGA approval)
|
Current Plasma Product |
Replacement Plasma Product |
Replacement Product Presentations |
Replacement Product Storage Conditions |
Replacement Product Shelf Life |
Expected Timing for Introduction to Hospitals |
|
ALBUMEX 20 (20% albumin) |
ALBUREX 20 AU* (20% albumin manufactured using the ALBUREX process) |
100mL, 20g 50mL, 10g |
Store below 25°C Do not freeze. Protect from light. |
36 months |
In progress - this transition commenced in April 2023 and is anticipated to be completed in 2025 |
|
INTRAGAM 10 (10% intravenous immunoglobulin) |
PRIVIGEN AU* (10% intravenous immunoglobulin manufactured using the PRIVIGEN process) |
200mL, 20g 100mL, 10g 50mL, 5g
|
Store below 25°C. Do not freeze. Protect from light. |
36 months |
In progress - this transition commenced in April 2023 and is anticipated to be completed in 2024 |
|
EVOGAM (16% subcutaneous immunoglobulin) |
HIZENTRA AU* (20% subcutaneous immunoglobulin manufactured using the HIZENTRA process) |
20mL, 4g 5mL, 1g |
Store below 25°C. Do not freeze. Protect from light. |
30 months |
In progress – this transition commenced in August 2023 and is anticipated to be completed in 2024 |
|
ALBUMEX 4 (4% albumin) |
ALBUREX 5 AU* (5% albumin manufactured using the ALBUREX process) |
500mL, 25g 250mL, 12.5g |
Store below 25°C. Do not freeze. Protect from light. |
36 months |
In progress – this transition commenced in September 2023 and is anticipated to be completed in 2024 |
|
PROTHROMBINEX-VF (prothrombin complex concentrate containing clotting factors II, IX and X) |
BERIPLEX P/N (temporary only) (prothrombin complex containing clotting factors II, VII, IX and X manufactured using the BERIPLEX process)
|
500IU FIX
|
Store below 25°C. Do not freeze. Protect from light.
|
36 months
|
Short term arrangement from June 2024 to when BERIPLEX AU is available |
|
BERIPLEX AU* (prothrombin complex containing clotting factors II, VII, IX and X manufactured using the BERIPLEX process) |
500IU FIX | Store below 25°C. Do not freeze. Protect from light. | 36 months | Late 2024/Early 2025# |
* the AU denotes the product is manufactured from plasma collected in Australia.
# timing is subject to TGA approval of the replacement product
Why are the products changing?
CSL Behring is expanding its manufacturing facility to support the processing of Australia’s growing plasma collections into plasma products. This will allow increased capacity and continued reliability. As part of this expansion CSL Behring will be changing how it manufactures these products to be in line with its global manufacturing processes. This alignment brings efficiencies that come from being part of the standardised global process and the opportunity to directly benefit from CSL Behring’s global investment in research and development.
When are the products changing?
The product transitions will be occurring during 2023 and 2024. The first of the products became available in April 2023. The timings shown in the table above are indicative and will depend on TGA approval for each product.
Information will be provided via relevant blood systems such as BloodNet and BloodSTAR as each product is transitioning to advise the exact timing, information on the products, ordering and inventory arrangements.
The transition from PROTHROMBINEXProthrombinex-VF, Australia’s current domestic prothrombin complex concentrate (PCC), will be taking place in two stages, with an initial short-term transition to imported BERIPLEX P/N prior to the introduction of BERIPLEX AU, Australia’s new domestic PCC.
What do I need to do?
Hospitals and clinicians need to prepare for each of the product changes by updating relevant protocols and systems.
Detailed information on the replacement products will be available on the CSL Behring websitewith links added to the Additional Resource section as each product is registered with the TGA.
Sample barcodes of the replacement products can also be found on the NBA website here. Some information systems may need to be updated as the format of the barcode for these products will only include a GS1 DataMatrix and human readable information as the Codabar format will be removed to meet international standards. This change is in line with other similar products supplied under the national blood arrangements and is in accordance with the relevant barcode specifications.
Clinicians who have patients that use the products that are no longer being manufactured are encouraged to discuss the change with their patients.
BloodSTAR and BloodNet records will be updated by the NBA prior to supply of the replacement products.
Where can I find out more information?
Further information will be released on BloodNet and BloodSTAR ahead of the transition of each product.
As each replacement product is registered, educational material will be available on the CSL Behring website and distributed by CSL Behring to hospitals. This material will include information on key differences between the existing and replacement products and information on dosing and administration.
For product and product administration questions please direct queries to the CSL Behring medical team on medicalinformation@cslbehring.com.au or 1800 642 865.
Queries about BloodSTAR authorisations and product ordering can be directed to your local Australian Red Cross Lifeblood Customer Service team (external link).
BloodNet, BloodSTAR and general queries can be directed to Supply.Management.Plasma@blood.gov.au or 13 000 BLOOD (13 000 25663).
Additional resources
ALBUREX 20 AU approved Product Information (external link)
ALBUREX 5 AU approved Product Information.pdf
ALBUREX 5 AU Sample Barcodes.pdf
HIZENTRA AU approved Product Information (external link)
PRIVIGEN AU approved Product Information (external link)
BERIPLEX P/N approved Product Information (external link)
Switching Immunoglobulin Products Pamphlet
Related NBA announcements
Announcement of product changes on 19 May 2022
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