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FDA Approves ZINBRYTA for Multiple Sclerosis
Biogen, AbbVie news release; 2016 May 27
The FDA has approved ZINBRYTA (daclizumab; Biogen, AbbVie), a new, once-monthly, self-administered, subcutaneous treatment for relapsing forms of multiple sclerosis (MS).
Indications: Due to its safety profile, the use of ZINBRYTA should generally be reserved for patients who have had an inadequate response to 2 or more therapies indicated for the treatment of MS.
Dosage/administration: The recommended dosage of ZINBRYTA is 150 mg injected subcutaneously once monthly. Patients are instructed to inject a missed dose as soon as possible but no more than 2 weeks late. After 2 weeks, they should skip the missed dose and take the next dose on schedule. Only one dose should be administered at a time.
Adverse reactions: The most common adverse reactions that occurred in ZINBRYTA-treated patients were nasopharyngitis, upper respiratory tract infection, rash, influenza, dermatitis, oropharyngeal pain, bronchitis, eczema, and lymphadenopathy compared with AVONEX; and upper respiratory tract infection, depression, rash, pharyngitis, and increased ALT (a type of liver enzyme) compared with placebo.
Citation: Biogen and AbbVie receive FDA approval for once-monthly ZINBRYTA (daclizumab) for multiple sclerosis. [news release]. Cambridge, MA, and Chicago, IL: Biogen, AbbVie; May 27, 2016: www.ZINBRYTA.com. Accessed May 31, 2016.