- Coadministration of eliglustat with some CYP2D6 and CYP3A inhibitors may significantly increase plasma concentrations of eliglustat that may cause prolongation of PR, QTc, and/or QRS cardiac intervals leading to cardiac arrhythmias; such drugs are contraindicated with eliglustat depending on the patients CYP2D6 metabolizer status e.g., EMs or IMs taking strong (e.g., paroxetine) or moderate (e.g., terbinafine) CYP2D6 inhibitor concomitantly with a strong (e.g., ketoconazole) or moderate (e.g., fluconazole) CYP3A inhibitor is contraindicated; IMs or PMs taking a strong CYP3A inhibitor (e.g., ketoconazole) is contraindicated
- Coadministration of eliglustat with drugs that are P-gp substrates (e.g., digoxin, phenytoin, colchicine, dabigatran etexilate) may result in increased concentrations of the concomitant drug; monitoring serum digoxin levels and reduction in digoxin dose may be required
- Substantially elevated eliglustat plasma concentrations may cause prolongation of PR, QTc, and/or QRS cardiac intervals, hence avoid using eliglustat in patients with pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, ventricular arrhythmia) and long QT syndrome
- Do not administer eliglustat in combination with Class IA (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmics
- Appropriate adverse event monitoring is recommended in poor CYP2D6 metabolizers
Cautions: Use cautiously in:
- Pregnant women
- Poor CYP2D6 metabolizers
- Patients using drugs that are P-gp substrates (e.g., digoxin)
- Patients using drugs that are CYP2D6 substrates (e.g., metoprolol, tricyclic antidepressants, phenothiazines)
Pregnancy Category:C
Breastfeeding: As per manufacturer's data, it is not known whether eliglustat is excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants from eliglustat, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.