Shortage of FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831) – Alternative supply from 1 September 2026

Dear Healthcare Professional,

Shortage of FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831)

Pro Pharmaceuticals Group recognises the importance of maintaining access to essential medicines in Australia and would like to provide an update regarding the supply of fludarabine phosphate injection.

The Australian-registered medicine, FLUDARABINE JUNO fludarabine phosphate 50 mg powder for injection vial (AUST R: 147831), sponsored by Juno Pharmaceuticals Pty Ltd, is currently in shortage due to manufacturing issues.

Pro Pharmaceuticals Group has arranged supply of an alternative product:

Fludarabine Phosphate 25 mg/mL (50 mg/2 mL) Concentrate for Solution for Injection/Infusion vial (Teva, UK).

This product is not registered in Australia. Its importation and supply have been authorised by the Therapeutic Goods Administration under section 19A of the Therapeutic Goods Act 1989.

The section 19A approval is effective from 1 September 2026 until 31 January 2027 and applies to the treatment of B-cell chronic lymphocytic leukaemia.

The Teva UK product is supplied as a ready-to-dilute concentrate containing 25 mg/mL of fludarabine phosphate, with each 2 mL vial containing 50 mg. This differs from the Australian-registered FLUDARABINE JUNO product, which is supplied as a powder requiring reconstitution.

Healthcare professionals should carefully review the approved Dear Healthcare Professional letter and UK product information before prescribing, preparing or administering the section 19A product, particularly regarding:

• Presentation and preparation differences

• Dilution and administration instructions

• Refrigerated storage requirements

• Approved indication and safety information

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For detailed information, including a comparison with the Australian-registered product, please refer to the TGA-approved Dear Healthcare Professional letter.

For orders or further information

Email: orders@propg.com.auPhone: 1300 077 674Website: www.propg.com.au

For regulatory or pharmacovigilance enquiries:

Email: regulatory@propg.com.au

Please circulate this information to the relevant pharmacy, oncology, haematology, procurement and clinical teams within your organisation.