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1 Indications And Usage Symdeko Is Indicated For The Treatment Of Patients With Cystic Fibrosis (Cf) Age 6 Years And Older Who Are Homozygous For The F508del Mutation Or Who Have At Least One Mutation In The Cystic Fibrosis Transmembrane Conductance Regulator ( Cftr ) Gene That Is Responsive To Tezacaftor/ivacaftor Based On In Vitro Data And/or Clinical Evidence [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. Symdeko Is A Combination Of Tezacaftor And Ivacaftor, Indicated For The Treatment Of Patients With Cystic Fibrosis (Cf) Age 6 Years And Older Who Are Homozygous For The F508del Mutation Or Who Have At Least One Mutation In The Cystic Fibrosis Transmembrane Conductance Regulator ( Cftr ) Gene That Is Responsive To Tezacaftor/ivacaftor Based On In Vitro Data And/or Clinical Evidence. ( 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.
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