What is the generic name?

RUXOLITINIB

What is the Trade Name for RUXOLITINIB?

JAKAFI

What are the Indications for RUXOLITINIB?

• 1. INDICATIONS AND USAGE Jakafi is a kinase inhibitor indicated for treatment of: intermediate or high-risk myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis in adults. ( 1.1 ) polycythemia vera in adults who have had an inadequate response to or are intolerant of hydroxyurea. ( 1.2 ) steroid-refractory acute graft-versus-host disease in adult and pediatric patients 12 years and older ( 1.3 ) chronic graft-versus-host disease after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older. ( 1.4 ) 1.1 Myelofibrosis Jakafi is indicated for treatment of intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults. 1.2 Polycythemia Vera Jakafi is indicated for treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea. 1.3 Acute Graft-Versus-Host Disease Jakafi is indicated for treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older. 1.4 Chronic Graft-Versus-Host Disease Jakafi is indicated for treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older.

References: https://open.fda.gov/