ZINBRYTA (daclizumab beta) – Voluntary Withdrawal in Canada due to Risk of Encephalitis
March 16, 2018
March 16, 2018
Type of communication:
Dear Healthcare Professional Letter
Source of recall:
Important Safety Information, Product withdrawal
Healthcare professionals involved in dispensing and administration of ZINBRYTA including multiple sclerosis (MS) specialists, neurologists, pharmacists, pharmacies, MS societies and MS patient support/advocacy groups.
- Following reports of serious inflammatory brain disorders, including immune-mediated encephalitis and meningoencephalitis, the manufacturer has decided to voluntarily withdraw ZINBRYTA from the Canadian market. The withdrawal is to be completed by April 30, 2018.
- No new patients can be started on or be prescribed ZINBRYTA.
- All treating healthcare professionals are advised to immediately contact patients in their care who have been prescribed ZINBRYTA, and to initiate alternative treatment options as soon as medically appropriate.
- Given ZINBRYTA’s potential for liver injury, patients discontinuing the product should have serum transaminase levels and total bilirubin levels monitored monthly, for 6 months after receiving their last dose of ZINBRYTA.
- Healthcare professionals should inform their patients that adverse drug reactions may also occur up to 6 months after discontinuation and to contact their physician immediately if any new symptoms such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting occur.
- ZINBRYTA will not be available through Health Canada’s Special Access Program.
Cases of immune-mediated encephalitis and meningoencephalitis, some with fatal outcomes, have been reported in patients treated with ZINBRYTA. No cases have been reported in Canada.
ZINBRYTA (daclizumab beta)
In Canada, ZINBRYTA was authorized for marketing under controlled distribution for the treatment of adult patients with active relapsing remitting multiple sclerosis (RRMS) who have had an inadequate response to, or who are unable to tolerate 1 or more therapies indicated for the treatment of this condition. As of February 28, 2018, over 8,000 patients have been treated with ZINBRYTA worldwide. In Canada, as of March 5, 2018, 30 patients have been treated with ZINBRYTA, of which 10 received the drug in clinical trials.
The European Medicines Agency (EMA) has recommended the immediate suspension of the marketing authorization and recall of ZINBRYTA following 12 reports of serious inflammatory brain disorders worldwide, including encephalitis and meningoencephalitis, some of which were fatal.
In parallel, the company has initiated a global voluntary withdrawal of ZINBRYTA from the market.
A preliminary review of the available evidence by the EMA indicates that immune reactions observed in the reported cases may be linked to the use of ZINBRYTA. ZINBRYTA may also be linked to severe immune reactions affecting several other organs.
Who is affected
Information for consumers
ZINBRYTA is a prescription medicine used to treat adults with active relapsing remitting forms of multiple sclerosis who have tried 1 or more multiple sclerosis medicines that have not been effective.
The company is removing ZINBRYTA from the market worldwide as cases of fatal inflammation of the brain have been reported in persons who had been prescribed ZINBRYTA. Patients who are being treated with ZINBRYTA should immediately contact their healthcare professional to discuss their treatment options since ZINBRYTA will no longer be available anywhere in the world.
Patients should let their healthcare professional know immediately if they experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting. These could be signs of a reaction to ZINBRYTA.
Regular blood tests are required for 6 months after stopping treatment, to check for possible side effects that may occur after stopping ZINBRYTA. Patients are advised to maintain their Patient Alert Card during treatment, for 6 months after stopping treatment or until they are advised to do so by their treating physician.
Patients in clinical trials should contact their treating physicians.
Information for healthcare professionals
Healthcare professionals are reminded:
- A withdrawal of ZINBRYTA will take place from pharmacies across Canada.
- Do not start new patients on ZINBRYTA.
- Contact patients under your care, who are currently being treated with ZINBRYTA to discuss alternative treatments.
- Monitor patients at least monthly and more frequently as clinically indicated for 6 months after the last dose of ZINBRYTA.
- Advise patients to immediately report symptoms of liver injury such as prolonged fever, severe headache, tiredness, jaundice, nausea or vomiting. These reactions can occur for 6 months after treatment has been stopped.
Action taken by Health Canada
Following Biogen’s completion of the voluntary withdrawal by April 30th 2018, Health Canada will discontinue the marketing authorization for ZINBRYTA and will not make it available through Health Canada’s Special Access Program. Health Canada is communicating this important safety information to healthcare professionals and to the public through its MedEffect™ Canada website.
Report health or safety concerns
Managing marketed health product-related side effects depends on healthcare professionals and consumers reporting them. Any case of encephalitis, severe cutaneous adverse reactions, drug-induced liver injury, autoimmune reactions affecting 1 or more organs, or other serious or unexpected side effects in patients receiving ZINBRYTA should be reported to Biogen Canada Inc. or Health Canada.
Biogen Canada Inc.
90 Burnhamthorpe Road W, Suite 1100
Canada L5B 3C3
ZINBRYTA Biogen ONE Support Program at 1-855-676-6300.
You can report any suspected adverse reactions associated with the use of health products to Health Canada by:
- Calling toll-free at 1-866-234-2345; or
- Visiting MedEffect Canada’s Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.
For other health product inquiries related to this communication, contact Health Canada at:
Marketed Health Products Directorate
Mihaela Vlaicu, MD
Country Medical Lead
For more information
The manufacturer advised Health Canada of the risk associated with this health product. Health Canada supports the actions taken by the manufacturer and as such a risk assessment was not required and a Summary Safety Review was not prepared.