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1 Indications And Usage Orkambi Is A Combination Of Lumacaftor And Ivacaftor Indicated For The Treatment Of Cystic Fibrosis (Cf) In Patients Age 2 Years And Older Who Are Homozygous For The F508del Mutation In The Cftr Gene. If The Patient's Genotype Is Unknown, An Fda-Cleared Cf Mutation Test Should Be Used To Detect The Presence Of The F508del Mutation On Both Alleles Of The Cftr Gene. Orkambi Is A Combination Of Lumacaftor And Ivacaftor, A Cystic Fibrosis Transmembrane Conductance Regulator (Cftr) Potentiator, Indicated For The Treatment Of Cystic Fibrosis (Cf) In Patients Age 2 Years And Older Who Are Homozygous For The F508del Mutation In The Cftr Gene. If The Patient's Genotype Is Unknown, An Fda-Cleared Cf Mutation Test Should Be Used To Detect The Presence Of The F508del Mutation On Both Alleles Of The Cftr Gene. ( 1 ) Limitations Of Use : The Efficacy And Safety Of Orkambi Have Not Been Established In Patients With Cf Other Than Those Homozygous For The F508del Mutation. ( 1 ) Limitations Of Use The Efficacy And Safety Of Orkambi Have Not Been Established In Patients With Cf Other Than Those Homozygous For The F508del Mutation .
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