Drug Identification Number (DIN): 02459620 (pre-filled syringe), 02459639 (pre-filled pen)
Biogen Canada Inc.
Zinbryta, also known as daclizumab, is a once monthly
self-administered monoclonal antibody. The antibody prevents
activation and growth of disease-causing immune cells. Zinbryta
also appears to increase the activity of certain beneficial
immune cells called
CD56 bright natural killer cells which can regulate the immune system by destroying disease-causing T cells.
In large clinical trials Zinbryta was shown to significantly decrease the number of MS relapses that occur compared to both a placebo and interferon beta-1a and helped to slow the accumulation of physical disability caused by MS compared to placebo.
Indications and use
Zinbryta (daclizumab) is indicated as a monotherapy for adults with active relapsing remitting multiple sclerosis (RRMS), who have had an inadequate response to, or are unable to tolerate, one or more therapies indicated for the treatment of relapsing forms of MS.
Zinbryta should only be prescribed by clinicians who are experienced in the diagnosis and management of MS and familiar with the safety and efficacy of the drug.
The safety and efficacy of Zinbryta have not been established in people with primary and secondary progressive multiple sclerosis.
Zinbryta is not approved for people with clinically isolated syndrome (CIS). For information on CIS approved treatment options, please speak with your physician or connect with an MS Society navigator at 1-844-859-6789.
The safety and efficacy of Zinbryta in children with MS below the age of 18 years have not yet been evaluated and should be used with caution in people aged 65 years and over.
Zinbryta is only available through a controlled distribution program called Biogen ONE® Support Program. Under this program, only prescribers and pharmacies registered with the program are able to prescribe and dispense the product. In addition, Zinbryta can only be dispensed as one injection per month, to patients who are registered and informed about the risks of Zinbryta and meet all the conditions of the Biogen ONE® Support Program including compliance with monthly monitoring and assessment of liver enzymes before the next dose of Zinbryta.
To access the Biogen ONE® Support Program please call 1-855-676-6300.
There are no adequate and well-controlled studies of Zinbryta in pregnant or nursing women.It is not known if Zinbryta will cause harm to an unborn baby or if Zinbryta is excreted in human milk.
Administration and dose
Zinbryta is self-administered at a dose of 150mg via subcutaneous (under the skin) injection once a month.
Mechanism of action (MOA)
Monoclonal antibodies are proteins which bind to a unique biological signature (called an antigen). In the case of Zinbryta, the target antigen is a protein found on the surface of immune cells, and it is thought that by blocking this protein, the drug prevents the inflammatory functions of T cells which cause damage to myelin in MS. Daclizumab may also be responsible for increasing the activation of helpful immune cells that regulate inflammation.
The most common adverse effects reported for Zinbryta include fatigue, headache, nausea, rash, musculoskeletal disorders, allergic reactions, infections, elevated liver enzymes, heart problems, and reduced platelet number.
Zinbryta can also cause more serious side effects including liver damage and severe skin reactions.
This is not a comprehensive list of all possible side effects of Zinbryta. Please see the Zinbryta product monograph for a full list of side effects. It is important that those with MS discuss side effects about any medication they are considering with their physician. (*Health Canada, product monograph for Zinbryta.)
In clinical trials, Zinbryta significantly reduced the
annualized relapse rate, slowed disability progression and
reduced the number of new or enlarging lesions.
DECIDE, a phase III trial with more than 1,800 participants from 28 countries, focused on comparing a once monthly subcutaneous injection of daclizumab to a once weekly intramuscular injection of interferon beta-1a in participants with RRMS over 144 weeks. Participants administered daclizumab showed a 45% reduction in annualized relapse rate compared to participants administered interferon beta-1a. Additional results revealed a 54% reduction in the number of new or enlarging brain lesions relative to interferon beta-1a at 96 weeks.
Phase IIb SELECT trial examined the effects of treatment with 150mg or 300mg daclizumab compared to a dummy drug (placebo) over 52 weeks in over 600 participants. Participants treated with daclizumab had lower relapse rates compared to placebo treated participants (150mg showed a 54% reduction; 300mg showed a 50% reduction), and more relapse free patients compared to the control group (150mg 81%; 300mg 80%).
The price of Zinbryta is approximately $27,700 per year. Zinbryta is currently being evaluated the Canadian Agency of Drugs and Technologies in Health (Common Drug Review) who will provide a recommendation for provincial public plan coverage for all Canadian provinces except Quebec. The Institut national d’excellence en sante et en services sociaux (INESS) in Quebec conducts an independent review.
Drug support program
Further information for persons with MS is available from Biogen ONETM program at 1-855-MSONE-00 or 1-855-676-6300.
Individuals are encouraged to discuss their disease management plans with their neurologist, keeping in mind their disease history and treatment goals, to determine whether changing therapies is a suitable option for them. Due to the large number of different MS therapies currently available, people are encouraged to discuss their disease management options with their health care team.
- Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O'Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28.
- Gold R, Giovannoni G, Selmaj K, Havrdova E, Montalban X, Radue EW, Stefoski D, Robinson R, Riester K, Rana J, Elkins J, O'Neill G; SELECT study investigators. Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial. Lancet. 2013 Jun 22;381(9884):2167-75.
Biogen® and Zinbryta™ are registered trademarks. All rights reserved.