Generic name: eliglustat 84mg
Dosage form: capsule
Medically reviewed on August 28, 2017.
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).
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: miscellaneous metabolic agents