Changes to New Zealand’s plasma products

New Zealand Blood Service (NZBS) will be rolling out changes to the domestic plasma products used by patients in New Zealand across the next two years.

The changes have been necessitated after NZBS’ plasma product manufacturer, CSL Behring, changed its manufacturing processes.

Five products – Intragam^® P (6% intravenous immunoglobulin), Evogam^® (16% subcutaneous immunoglobulin), Albumex^® 4 (4% albumin), Albumex^® 20 (20% albumin), and Prothrombinex-VF^® (prothrombin complex concentrate containing clotting factors II, IX and X) – will be phased out between mid-2023 and the end of 2025.

They will be replaced by PRIVIGEN^® NZ (10% intravenous immunoglobulin), HIZENTRA^® NZ (20% subcutaneous immunoglobulin), ALBUREX^® 5 NZ (5% albumin), ALBUREX^® 20 NZ (20% albumin) and BERIPLEX^® NZ (prothrombin complex containing clotting factors II, VII, IX and X) respectively.

“The replacement products will continue to be manufactured in Australia from plasma collected in New Zealand by NZBS, but will be manufactured using CSL Behring’s global manufacturing processes,” says Dr Sarah Morley, Chief Medical Officer.

“The safety of all our products for patients is our number one priority. The replacement products will be manufactured to the same robust quality and safety standards and be just as effective. As per the current products, they will comply with the Therapeutic Goods Administration’s safety and efficacy requirements and go through Medsafe’s New Medicines Approval Process.”

In addition, GAMUNEX^® 10%, an intravenous immunoglobulin (IVIg) product, will be introduced as an alternative commercial option for patients who do not tolerate PRIVIGEN^® NZ or PRIVIGEN^® from mid-2023.

Kybernin P, a commercial CSL Behring anti-thrombin III product, will be introduced in early 2024 to replace Thrombotrol-VF (antithrombin III complex), which will no longer be manufactured.

Biostate will no longer be supplied in the 500 IU presentation. However, the 1000 IU will be retained.

NZBS has consulted healthcare professionals about the changes to New Zealand’s domestic plasma products.

Healthcare professionals will be provided with educational material explaining the key differences between the existing and replacement products, and information on dosing and administration as part of the preparation to launch each new product.

Plasma product transition timeline

For further information on changes to immunoglobulin products:

• Patients
• Healthcare professionals
• Changes to New Zealand's Plasma Products from 2023 - 2025

^{PRIVIGEN® NZ, PRIVIGEN®, HIZENTRA® NZ, HIZENTRA®, ALBUREX® 5 NZ, ALBUREX® 20 NZ and BERIPLEX® NZ are registered trademarks of CSL Group of Companies.}

^{Intragam® P, Evogam®, Albumex® 4, Albumex® 20 and Prothrombinex-VF® are registered trademark of CSL Limited}

^{GAMUNEX® 10%  = Registered Trademark of Grifols.}