Page 1 Page 2 Page 3 Page 4 Page 5 Page 6 Page 7 Page 8 Page 9 Page 10 Page 11 Page 12 Page 13 Page 14 Page 15 Page 16 Page 17 Page 18 Page 19 Page 20 Page 21 Page 22 Page 23 Page 24 Page 25 Page 26 Page 27 Page 28 Page 29 Page 30 Page 31 Page 32 Page 33 Page 34 Page 35 Page 36 Page 37 Page 38 Page 39 Page 40 Page 41 Page 42 Page 43 Page 44 Page 45 Page 46 Page 47 Page 48 Page 49 Page 50 Page 51 Page 52 Page 53 Page 54 Page 55 Page 56 Page 57 Page 58 Page 59 Page 60 Page 61 Page 62 Page 63 Page 64 Page 65 Page 66 Page 67 Page 6863 msfocusmagazine.org Approved for: Relapsing MS Delivered by: Injection Frequency: Monthly When: Typically when 2 or more treatments have failed Special monitoring required? Yes Zinbryta REMS PROGRAM – Information for Patients* Before the first prescription, Review the FDA - approved patient guide patients should: Receive counseling from your prescriber about the risks of severe and fatal hepatic injury, and serious immune-mediated disorders, as well as required baseline and monthly monitoring Enroll in the REMS by completing the patient enrollment form with the prescriber Receive a blood test to assess hepatic (liver) function Monthly during treatment Receive a blood test to assess hepatic (liver) function Monthly after discontinuing Receive a blood test for six months Because of the serious adverse events associated with Zinbryta, the product is generally reserved for patients who have had two or more previous DMT therapies fail. Dr. Thrower said, “Zinbryta provides an additional choice to patients who require a new option for treatment. The drug is probably best suited for patients who have tried several other therapies without success.” * Source: www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=357