Generic Name and Formulations:
Eliglustat 84mg; hard-gel caps.
Sanofi Genzyme Company
Indications for CERDELGA:
Long-term treatment of adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate, or poor metabolizers as detected by an FDA-cleared test. Limitations of use: CYP2D6 ultra-rapid metabolizers may not achieve adequate concentrations for a therapeutic effect. No dosage recommendation for CYP2D6 indeterminate metabolizers.
Swallow whole with water. Extensive and intermediate metabolizers: 84mg twice daily. Poor metabolizers: 84mg once daily; monitor. Extensive and intermediate metabolizers taking strong or moderate CYP2D6 inhibitors (eg, paroxetine, terbinafine); or extensive metabolizers taking strong or moderate CYP3A inhibitors (eg, ketoconazole, fluconazole): reduce to 84mg once daily. Currently on imiglucerase, velaglucerase alfa, or taligucerase alfa: administer eliglustat 24hrs after last dose of the previous enzyme replacement therapy.
Extensive or intermediate metabolizers taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor. Intermediate or poor metabolizers taking a strong CYP3A inhibitor (eg, ketoconazole).
Determine CYP2D6 genotype using an FDA-cleared test. Pre-existing cardiac disease (CHF, recent MI, bradycardia, heart block, ventricular arrhythmia), long QT syndrome: not recommended. Moderate-to-severe renal impairment, ESRD, hepatic impairment, cirrhosis: not recommended. Pregnancy (Cat.C). Nursing mothers: not recommended.
See Contraindications. Increased risk of arrhythmias with concomitant CYP2D6 and CYP3A inhibitors; adjust dose based on metabolizer status (see full labeling). Avoid grapefruit or grapefruit juice. Concomitant Class IA (eg, quinidine, procainamide) and Class III (eg, amiodarone, sotalol) antiarrhythmics, CYP3A inducers (eg, rifampin, carbamazepine, phenobarbital, phenytoin, St. John’s wort): not recommended. Concomitant digoxin; reduce digoxin dose by 30% and monitor. Potentiates P-gp substrates (eg, phenytoin, colchicine, dabigatran etexilate) or CYP2D6 substrates (eg, metoprolol, tricyclic antidepressants, phenothiazines); monitor and consider reducing dose of these drugs.
Glucosylceramide synthase inhibitor.
Fatigue, headache, nausea, diarrhea, back pain, pain in extremities, upper abdominal pain; ECG changes, arrhythmias.
Blister card (14 caps)—1, 4