Generic name: eliglustat 84mg
Dosage form: capsule
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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 is 84 mg twice daily in CYP2D6 EMs and IMs. The recommended dosage in CYP2D6 PMs is 84 mg once daily; appropriate adverse event monitoring is recommended [see Adverse Reactions (6.1)]. The predicted exposures with 84 mg once daily in patients who are CYP2D6 PMs are expected to be similar to exposures observed with 84 mg twice daily in CYP2D6 IMs [see Clinical Pharmacology (12.3)].
Some inhibitors of CYP2D6 and CYP3A are contraindicated with CERDELGA depending on the patient's metabolizer status [see Contraindications (4)]. Co-administration of CERDELGA with other CYP2D6 and CYP3A inhibitors may require dosage adjustment depending on the patient's CYP2D6 metabolizer status to reduce the risk of potentially significant adverse reactions [see Table 3 and Table 4 in Drug Interactions (7.1)].
Reduce the dosage of CERDELGA to 84 mg once daily for:
- CYP2D6 EMs and IMs taking strong or moderate CYP2D6 inhibitors
- CYP2D6 EMs taking strong or moderate CYP3A inhibitors
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 with CERDELGA because grapefruit is a strong CYP3A inhibitor [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).