|
1 Indications And Usage Kalydeco Is A Cystic Fibrosis Transmembrane Conductance Regulator (Cftr) Potentiator Indicated For The Treatment Of Cystic Fibrosis (Cf) In Patients Age 6 Months And Older Who Have One Mutation In The Cftr Gene That Is Responsive To Ivacaftor Potentiation Based On Clinical And/or In Vitro Assay Data [See Clinical Pharmacology (12.1) And Clinical Studies (14) ] . If The Patient's Genotype Is Unknown, An Fda-Cleared Cf Mutation Test Should Be Used To Detect The Presence Of A Cftr Mutation Followed By Verification With Bi-Directional Sequencing When Recommended By The Mutation Test Instructions For Use. Kalydeco Is A Cystic Fibrosis Transmembrane Conductance Regulator (Cftr) Potentiator Indicated For The Treatment Of Cystic Fibrosis (Cf) In Patients Age 6 Months And Older Who Have One Mutation In The Cftr Gene That Is Responsive To Ivacaftor Based On Clinical And/or In Vitro Assay Data. ( 12.1 , 14 ) If The Patient's Genotype Is Unknown, An Fda-Cleared Cf Mutation Test Should Be Used To Detect The Presence Of A Cftr Mutation Followed By Verification With Bi-Directional Sequencing When Recommended By The Mutation Test Instructions For Use. ( 1 )
|