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 Access 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
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.