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1 Indications And Usage Cerdelga Is Indicated For The Long-Term Treatment Of Adult Patients With Gaucher Disease Type 1 (Gd1) Who Are Cyp2d6 Extensive Metabolizers (Ems), Intermediate Metabolizers (Ims), Or Poor Metabolizers (Pms) As Detected By An Fda-Cleared Test [See Dosage And Administration (2.1) ] . Cerdelga Is A Glucosylceramide Synthase Inhibitor Indicated For The Long-Term Treatment Of Adult Patients With Gaucher Disease Type 1 Who Are Cyp2d6 Extensive Metabolizers (Ems), Intermediate Metabolizers (Ims), Or Poor Metabolizers (Pms) As Detected By An Fda-Cleared Test. ( 1 ) Limitations Of Use : Cyp2d6 Ultra-Rapid Metabolizers May Not Achieve Adequate Concentrations Of Cerdelga To Achieve A Therapeutic Effect. ( 1 ) A Specific Dosage Cannot Be Recommended For Cyp2d6 Indeterminate Metabolizers. ( 1 ) Limitations Of Use : Patients Who Are Cyp2d6 Ultra-Rapid Metabolizers (Urms) May Not Achieve Adequate Concentrations Of Cerdelga To Achieve A Therapeutic Effect [See Clinical Studies (14) ]. A Specific Dosage Cannot Be Recommended For Those Patients Whose Cyp2d6 Genotype Cannot Be Determined (Indeterminate Metabolizers) [See Clinical Studies (14) ] .
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