Information updates

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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