Information updates

Updated ASCIA OIT for food allergy information

4 March 2020:

Oral immunotherapy (OIT) is a potential treatment for food allergy. It involves giving gradually increasing amounts of food allergen under medical supervision and continued daily consumption of the food allergen. If the goal of desensitisation is reached, there is a temporary increase in the amount of food allergen that can be consumed before an allergic reaction occurs.

OIT is an emerging treatment, and there are no OIT products for food allergies registered by the Therapeutic Goods Administration (TGA) in Australia or Medsafe in New Zealand. One OIT product for peanut allergy (PalforziaTM developed by the company Aimmune Therapeutics) has received Food and Drug Administration (FDA) approval for use in the USA in 2020.

ASCIA OIT for food allergy information for patients, consumers and carers has been updated and is now available on the ASCIA website www.allergy.org.au/patients/allergy-treatment/oral-immunotherapy-for-food-allergy

The main updates include:

It is important to note that current OIT methods are not a cure for food allergy. There are concerns about potential harm of OIT for food allergy outweighing the benefits in some people with severe food allergy, as well as considerable cost implications. This applies to OIT products that are registered as well as OIT used in clinical trials.

The benefits and harms of different forms of OIT are still being studied in clinical trials in Australia and globally. More data needs to be collected about safety, tolerability, cost-effectiveness, quality of life and long term outcomes.

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Updated ASCIA HAE information

1 March 2020

ASCIA has updated its information on hereditary angioedema (HAE), to be consistent with international guidelines and include new treatments, and the following resources are now available on the ASCIA website www.allergy.org.au/hp/papers/hereditary-angioedema

  • Updated ASCIA HAE Position Paper.
  • New ASCIA HAE Management Plan (pdf with type in fields), which replaces the ASCIA HAE Action Plan.
  • New ASCIA HAE Case Peer Review Form (pdf with type in fields), which needs to be completed when requesting prophylaxis dose increases using a new treatment option - Berinert® SC.

For information regarding danazol supply in Australia please refer to www.allergy.org.au/about-ascia/info-updates/product-supply-update-danazol

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Product supply update – danazol

28 February 2020

Danazol is used in some patients for the management of hereditary angioedema (HAE). Danazol (Azol) has recently been discontinued (in January 2020) in Australia by the supplier (Mylan, formerly Alphapharm), as reported on the TGA website https://apps.tga.gov.au/Prod/msi/Search/Details/danazol  Other brands of danazol may be sourced using a Special Acces Scheme (SAS) application to the TGA. Please refer below for further information.  In New Zealand danazol is still available from Mylan.  

For patients who will no longer be prescribed danazol, ASCIA recommends that they should gradually run down supplies and not stop suddenly, as this could result in increased HAE attacks. For example, they may half their usual dose until supply is finished.

All patients with HAE should have adequate supplies of Icatibant (Firazyr®) on hand, and if possible they should keep a written diary of HAE attacks for at least a month, as they may qualify for Berinert® SC.  

Access to other brands of danazol in Australia

The Therapeutic Goods legislation provides a number of avenues through which Australian residents and medical practitioners may access therapeutic goods which are not registered in Australia. One of these avenues is the Special Access Scheme (SAS), which refers to arrangements to allow for the import and/or supply of an unapproved therapeutic good for a single patient, on a case by case basis. To access unapproved danazol  via the SAS, a patient’s doctor can submit an application to the TGA. Further information regarding the SAS and the relevant application forms are available from the TGA website: https://www.tga.gov.au/form/special-access-scheme. Should the doctor have enquiries regarding the SAS, the doctor can email This email address is being protected from spambots. You need JavaScript enabled to view it..

As these products are not approved for marketing in Australia, the TGA is unable to vouch for the quality, safety or efficacy of unapproved products. Suppliers (sponsors) who have advised that they may be able to bring in danazol products under SAS are:

  • Medsurge Healthcare Pty Ltd – Ph: 1300 788 261
  • Link Medical Products Pty Ltd – 1800 181 060
  • HL Pharma Pty Ltd – 03 9823 6228

There may be other suppliers who can also supply danazol under SAS.

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Supply update - EpiPen® Jr 150 microgram adrenaline (epinephrine) autoinjector

25 February 2020

Mylan Australia has advised that there has been sufficient supply of EpiPen® Jr 150 microgram adrenaline (epinephrine) autoinjectors since early February 2020 at wholesalers and at Mylan’s warehouse to meet current patient needs in Australia.

Orders from wholesalers and pharmacies are being filled as they are received. As a result, EpiPen® Jr has been removed from the Therapeutic Goods Administration (TGA) Medicines Shortage Information Initiative website.  Mylan Australia’s dedicated, toll-free EpiPen Customer Service hotline 1800 931 625 remains up and running for any enquiries.

To ensure that supply channels are aware of this news, Mylan has emailed the attached notice to pharmacists. The notice is also being distributed by the Pharmacy Guild of Australia and the Pharmaceutical Society of Australia.

pdfEpiPen supply update 24 Feb 2020160.28 KB

Mylan Australia thanks the allergy and anaphylaxis community for its patience during the recent supply shortage.

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Pesto products recalled due to peanut contamination

21 February 2020

There have been several pesto products recalled in recent weeks because they contain an undeclared allergen (peanut). The peanuts were in one of the ingredients (cashews) used in these products.

Allergy & Anaphylaxis Australia (A&AA) has worked with Food Standards Australia New Zealand (FSANZ) and they have released a statement on the FSANZ website: www.foodstandards.gov.au/consumer/generalissues/Pages/-Undeclared-peanut-in-imported-pesto-products-containing-cashews.aspx

A&AA is continuing to work with industry stakeholders to find out where and how the contamination is occurring and they expect more products to be recalled in the near future.

Some manufacturers are now starting to return potentially contaminated products to shelf, with the addition of a precautionary allergen labelling (PAL) statement. It is important that consumers take PAL statements for peanut seriously when eating products containing cashew if they have a peanut allergy.  

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Updated ASCIA anaphylaxis e-training courses

20 February 2020

All versions of ASCIA anaphylaxis e-training courses have been updated in 2020 to include recent changes to ASCIA Action Plans and Guidelines.  These courses are available at:

ASCIA anaphylaxis e-training courses continue to lead the world in providing accessible, consistent and evidence-based training for schools, early childhood education/care (ECEC), health professionals, first aid providers, patients, consumers and carers. More than 100,000 people were trained in the past year using ASCIA anaphylaxis e-training courses and more than 20,000 people have already registered over the past month for ASCIA anaphylaxis e-training courses for schools, ECEC and community.

All ASCIA anaphylaxis e-training courses now include the following changes to ASCIA Action Plans and Guidelines:

  • The weight range for adrenaline autoinjectors (150 mcg) has changed from 10-20kg to 7.5-20kg, to be consistent with ASCIA Guidelines and consensus expert opinion.
  • The section for the doctor or nurse practitioner to complete in the RED and GREEN plans is more detailed and clearer.
  • The ORANGE plan (used mostly as a poster) has a new title “ASCIA First Aid Plan for Anaphylaxis” and translated versions of this plan are available on the ASCIA website.

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Venom Immunotherapy (VIT) Product Supply Update

19th February 2020

Hymenoptera® honey bee, paper wasp nad yellow jacket venom products are currently all in stock in Australia and New Zealand.  However, the manufacturer of Hymenoptera® venom products (Jubilant HollisterStier LLC) has advised Stallergenes Greer of a critical manufacturing issue, which will negatively impact their ability to ship venoms outside of the USA in the short term. A further update on supply will be available in April 2020.

In the meantime, 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, please refer to the ASCIA website for further information: www.allergy.org.au/members/insect-allergy 

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Updated 2020 versions of ASCIA Action Plans are now available

30 January 2020

ASCIA Action Plans for Anaphylaxis (RED) and ASCIA Action Plan for Allergic Reactions (GREEN) ASCIA Action Plans for Anaphylaxis (RED) and ASCIA Action Plan for Allergic Reactions (GREEN) have been updated in January 2020 and are available at www.allergy.org.au/hp/anaphylaxis/ascia-action-plan-for-anaphylaxis

Whilst the 2020 ASCIA Action Plans are the latest versions, the 2018 and 2017 versions of ASCIA Action Plans are still valid for use throughout 2020 and 2021, or until the due date for review stated on the plan. 

ASCIA anaphylaxis e-training courses for schools, early childhood education/care and community have also been updated in January 2020, to include the following changes that have been made to ASCIA Action Plans: 

  • The weight range for adrenaline autoinjectors (150 mcg) has changed from 10-20kg to 7.5-20kg, to be consistent with ASCIA Guidelines and consensus expert opinion.
  • The section for the doctor or nurse practitioner to complete In the RED and GREEN plans is more detailed and clearer, with dot points about medications and the review date.
  • The ORANGE plan (used mostly as a poster) has a new title “ASCIA First Aid Plan for Anaphylaxis” is available at www.allergy.org.au/hp/anaphylaxis/ascia-action-plan-for-anaphylaxis and translated versions are available at www.allergy.org.au/hp/anaphylaxis#ta5  .

The 2020 versions of ASCIA Action Plans will also be included in the updated ASCIA anaphylaxis e-training course for health professionals, which we expect will be finalised by early March 2020. 

For more information about the changes to ASCIA Action Plans go to www.allergy.org.au/hp/anaphylaxis/action-plans-for-allergic-reactions-faq   

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