Applies to the following strengths: 84 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Gaucher Disease
CYP450 2D6 Extensive metabolizers (EMs) and Intermediate Metabolizers (IMs): 84 mg orally twice a day
CYP450 2D6 Poor Metabolizers (PMs): 84 mg orally once a day
EMs and IMs taking strong or moderate CYP450 2D6 inhibitors: 84 mg orally once a day
EMs taking strong or moderate CYP450 3A inhibitors: 84 mg orally once a day
Comments: It is recommended to establish the CYP450 2D6 genotype of each patient using an FDA-cleared test before starting treatment.
Use: Long-term treatment of patients with Gaucher disease type 1 who are CYP450 2D6 extensive metabolizers, intermediate metabolizers, or poor metabolizers.
Renal Dose Adjustments
Mild Renal Dysfunction: No dose adjustment recommended.
Moderate to Severe Renal Dysfunction: Not recommended
Liver Dose Adjustments
-Co-administration of eliglustat with other CYP450 2D6 and CYP450 3A inhibitors may require dosage adjustments depending on the patient's metabolizer status to reduce the risk of potentially significant adverse reactions.
-Reduce the dosage of eliglustat to 84 mg once daily for EMs and IMs taking strong or moderate CYP450 2D6 inhibitors.
-Reduce the dosage of eliglustat to 84 mg once daily for EMs taking strong or moderate CYP450 3A inhibitors.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-Swallow capsules whole, preferably with water, and do not crush, dissolve, or open the capsules
-Avoid the consumption of grapefruit or grapefruit juice with this drug as grapefruit is a strong CYP450 3A inhibitor
-For patients currently treated with imiglucerase, velaglucerase alfa, or
taliglucerase alfa, this drug may be administered 24 hours after the last dose of the previous enzyme replacement therapy (ERT).
Monitoring: Monitor therapeutic drug concentrations or consider reducing the dosage of concomitant P-gp or CYP450 2D6 substrates.
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- Drug class: miscellaneous metabolic agents
Other brands: Cerdelga