ASH Clinical News July 2016

For adult and pediatric patients with hemophilia A Help Him REACH HIGHER With Long-lasting Protection AFSTYLA is the first and only recombinant Factor VIII that delivers proven, long-lasting bleed protection with a novel single-chain design WEEKLY AVAILABLE Flexibility to dose 2x or 3x weekly ZERO BLEEDS COMPARABLE TO (median AsBR*) VIII In all studied populations regardless of dosing regimen Identical to endogenous Factor VIII once activated NATURAL FACTOR Zero inhibitors observed—Low incidence of adverse reactions in clinical trials The most common adverse reactions reported in clinical trials (>0.5%) were dizziness and hypersensitivity. Visit AFSTYLA.com *Annualized spontaneous bleeding rate in clinical trials (IQR=0–2.4 for patients ≥12 years). Indications and Important Safety Information AFSTYLA is indicated in adults and children with hemophilia A (congenital Factor VIII deficiency) for: • On-demand treatment and control of bleeding episodes • Routine prophylaxis to reduce frequency of bleeding episodes • Perioperative management of bleeding AFSTYLA is not indicated for the treatment of von Willebrand disease. AFSTYLA is contraindicated in patients who have had life-threatening hypersensitivity reactions to AFSTYLA or its excipients, or to hamster proteins. AFSTYLA is for intravenous use only. AFSTYLA can be self-administered or administered by a caregiver with training and approval from a healthcare provider or hemophilia treatment center. Higher and/or more frequent dosing may be needed for patients under 12 years of age. Hypersensitivity reactions, including anaphylaxis, are possible. Advise patients to immediately report symptoms of a hypersensitivity reaction. If symptoms occur, discontinue AFSTYLA and administer appropriate treatment. Development of Factor VIII (FVIII) neutralizing antibodies (inhibitors) can occur. If expected FVIII activity levels are not attained or bleeding is not controlled with appropriate dose, perform an assay to measure FVIII inhibitor concentration. Monitor plasma FVIII activity using a chromogenic assay or one-stage clotting assay. If one-stage clotting assay is used, multiply result by a conversion factor of 2 to determine FVIII activity level. The most common adverse reactions reported in clinical trials (>0.5%) were dizziness and hypersensitivity. AFSTYLA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC. AFSTYLA® is a registered trademark of CSL Behring Recombinant Facility AG. Biotherapies for Life® is a registered trademark of CSL Behring LLC. ©2016 CSL Behring LLC 1020 First Avenue, PO Box 61501, King of Prussia, PA 19406-0901 USA www.CSLBehring-us.com www.AFSTYLA.com AFS16-04-0025 5/2016

ASH Clinical News July 2016 | Page 41