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 [see Indications and Usage (1)].

Recommended Adult Dosage

The recommended dosage of CERDELGA in adults is based on the patient's CYP2D6 metabolizer status.

Dosage Adjustment in EMs and IMs With or Without Hepatic Impairment and Concomitant Use of CYP2D6 or CYP3A Inhibitors

Reduce dosage frequency of CERDELGA 84 mg to once daily in CYP2D6 EMs and IMs with or without hepatic impairment taking CYP2D6 or CYP3A inhibitors, as shown in Table 2 [see Warnings and Precautions (5.1), Drug Interactions (7.1), Use in Specific Populations (8.7)].

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 (7.1)].
• 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).