Indication and Dosage of Cerdelga

 INDICATIONS

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].
Limitations Of Use

   named  Patient program who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect [see Clinical Studies].
    A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers) [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients with Gaucher disease type 1 based on their CYP2D6 metabolizer status. It is recommended patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype.

Important Administration Instructions

•     Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules.
•     CERDELGA can be taken with or without food.
•     Avoid the consumption of grapefruit or grapefruit juice (strong CYP3A inhibitors) with CERDELGA [see DRUG INTERACTIONS].
•     If a dose of CERDELGA is missed, take the prescribed dose at the next scheduled time; do not double the next dose.
•     For patients currently treated with imiglucerase, velaglucerase alfa, or taliglucerase alfa, CERDELGA may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT).