Venom immunotherapy products: supply update

26 March 2019

The manufacturer JHS in the US has informed Stallergenes Greer about a short supply situation of venom products.  JHS notified the FDA earlier this month that they were not able to supply the required quantities of venom product necessary to meet US demand, which prompted a hold of all venom shipments outside of the United States.

We expect the FDA to lift this hold after JHS have successfully completed their scheduled maintenance shutdown and resume production of venom products in April.  Until JHS can continue normal supply to countries outside the US, we might encounter low stock on some venom products in Australia or New Zealand.  We will continue to keep you informed as the situation unfolds.

Please find below an update of current Hymenoptera® venom product availability in Australia and New Zealand:

Honey Bee venom

Paper Wasp venom

Yellow Jacket venom

For any further assistance, please contact Stallergenes Greer according to the information set out below:

Registered and replacement venom products: differences in external appearance

Stallergenes Greer is continuing efforts to secure the supply of registered ALBEY® venom products. Replacement Hymenoptera® venom products and replacement sterile Greer diluents (which are both FDA registered products in the US) have been authorised by the TGA for supply in Australia under S19A(1) of the Therapeutic Goods Act and New Zealand under S26 of the Therapeutic Goods Act.

Whilst the external appearance of the replacement products and registered products differ, they are identical in terms of the:

The registered and replacement products are both delivered from the manufacturer in sterile vials within tamper-evident packaging: e.g. within sealed external plastic packaging in the case of the replacement Greer diluents, and within vials with breakable caps in the case of the registered ALBEY® diluents. In the case of the replacement Greer diluents, the Certificate of Conformance released by Greer Quality Assurance is available here:

pdfCertificate of Conformance - Albumine-Saline Diluent 9mL x25 Batch 350890.pdf255.74 KB

This document confirms that the products supplied as detailed above have passed all test requirements (e.g. sterility) and have met all defined product specifications required by the FDA.

If you remove these products from their original tamper-evident packaging to provide to third parties for administration, please explain the difference in the external appearance of the product and refer to this communication if necessary.

Stallergenes Greer understands the impact of this shortage on both patients and prescribers and are committed to ensuring reliable supply of these important products into Australia and New Zealand on an ongoing basis. We will provide further updates as soon as more information is available.

In case of future shortages, for guidance on how to make decisions about the appropriate care for patients currently receiving venom immunotherapy, and measures to avoid interruptions to therapy in high-risk patients, you may wish to refer to the following websites:

Content updated 26 March 2019