Venom Immunotherapy (VIT)
Hymenoptera® venom product supply update
The manufacturer of Hymenoptera venom products (Jubilant HollisterStier LLC) has recently received FDA approval to use their Clinical Trial Materials line for commercial production. This is expected to increase supply availability outside of the US market by approximately 30%, and we are now in a position to increase supply locally.
A first additional shipment of Honey Bee has already arrived in Australia and will be released following repacking next week (please allow one additional week before release in New Zealand). A second significant quantity has also been secured for shipment in October. Given the increase in local availability, we will be restoring normal access to these products by wholesalers in both Australia and New Zealand.
For assistance with venom orders, please contact your Stallergenes Greer territory manager:
Due to the limited stock of Hymenoptera® Honey Bee venom it is recommended that commencement of Honey Bee venom immunotherapy in new patients is delayed until continuation of venom supply is assured. Completion of Honey Bee venom immunotherapy may be considered in lower-risk patients who have completed three years of maintenance therapy, instead of continuing for five years.
For guidance on how to make decisions about the appropriate care for patients currently receiving Honey Bee venom immunotherapy, including measures to avoid interruptions to therapy in high-risk patients, you may consider the recommendations summarised below, which are also on the ASCIA website www.allergy.org.au/members/allergen-immunotherapy (members section).
- Defer commencement of venom immunotherapy in new cases until continuation of venom supply is assured.
- Complete venom immunotherapy in lower-risk patients who have completed three years of maintenance therapy, instead of continuing for five years.
In high-risk patients the above measures should be subject to clinical discretion.
- Increase to 6-weekly interval after 6 months of treatment.
- Increase to 8-weekly interval after 1 year of treatment.
- Increase to 3-monthly interval after 2 years of treatment.
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:
- drug substance and materials;
- equipment and method of manufacture of drug substance and finished product; and
- immediate container and closure.
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:
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:
- ASCIA website members section www.allergy.org.au/members/allergen-immunotherapy
- AAAAI/ACAAI Joint Venom Extract Shortage Task Force Report www.annallergy.org/article/S1081-1206(17)30102-3/fulltext
Content updated September 2020