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Product withdrawn after overseas reports of inflammatory brain disorders
Consumers and health professionals are advised that Biogen Australia, in consultation with the TGA, will withdraw Zinbryta (daclizumab) from the Australian market following cases of serious inflammatory brain disorders in Europe.
Zinbryta is used for the treatment of relapsing forms of multiple sclerosis to delay the progression of physical disability and to reduce the frequency of relapse. It can only be prescribed to patients who are being treated by a neurologist.
The TGA has not received any reports of inflammatory brain disorders occurring in Australian patients who have been prescribed Zinbryta.
Biogen will be coordinating a worldwide withdrawal of Zinbryta. To give time for Australian patients to transition off the medicine it will be supplied in Australia until 31 May 2018.
Information for consumers
If you or somebody you provide care for are being treated with Zinbryta you should be contacted by your treating health professional to discuss alternative treatment options. If you have not yet been contacted you should contact them as soon as possible.
Be aware that adverse drug reactions to Zinbryta could potentially occur up to six months after discontinuation. Contact a health professional immediately if any new symptoms such as prolonged fever, serious headache, nausea or vomiting occur.
Information for health professionals
Biogen Australia has written to health professionals who treat patients with Zinbryta explaining the situation and advising on the next steps.
If you are treating any patients who use Zinbryta be alert to this issue.
Explain the situation to them and ensure they are referred to their treating neurologist to arrange alternative treatments.
Information for neurologists
Cases of immune-mediated encephalitis and meningoencephalitis have been reported in overseas patients treated with Zinbryta. Given the nature and complexity of adverse events being reported around the world, Biogen Australia has stated that characterising the evolving benefit/risk profile of Zinbryta would not be possible with the limited number of patients being treated. Therefore, Biogen Australia considered it was in the best interest of patients to withdraw worldwide marketing authorisations for Zinbryta.
Given the impending withdrawal of Zinbryta in Australia, Biogen Australia has recommended the following:
- No new patients should start treatment with Zinbryta.
- Patients currently being treated with Zinbryta should be contacted immediately to discuss alternative treatment management plans.
- All patients discontinuing Zinbryta should be informed that adverse drug reactions may also occur up to six months after discontinuation and be advised to contact their physician immediately if any new symptoms such as prolonged fever, serious headache, nausea or vomiting occur.
- Be aware that other immune-mediated disorders, such as blood dyscrasias, thyroiditis or glomerulonephritis can occur.
- Patients stopping the product should be monitored at least monthly and more frequently as clinically indicated for up to six months after the last dose of Zinbryta.
- Be aware that product supply will cease by 31 May 2018.
Consumers and health professionals are encouraged to report problems with medicines or vaccines. Your report will contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.