Generic Name and Formulations:
Eliglustat 84mg; caps.
Sanofi Genzyme Company
Indications for CERDELGA:
Long-term treatment of adults with Gaucher disease type 1 who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) 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. EMs and IMs: 84mg twice daily. PMs: 84mg once daily; monitor. EMs and IMs without hepatic impairment taking a strong or moderate CYP2D6 inhibitor; or EMs without hepatic impairment taking a strong or moderate CYP3A inhibitor; or EMs with mild hepatic impairment taking a weak CYP2D6 inhibitor or any CYP3A inhibitor: 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.
EMs and IMs taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor. EMs with moderate or severe hepatic impairment, or with mild hepatic impairment taking a strong or moderate CYP2D6 inhibitor. IMs and PMs taking a strong CYP3A inhibitor or with any degree of hepatic impairment.
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. Renal impairment: avoid in IMs and PMs. ESRD (with or without dialysis): avoid in EMs. Pregnancy. Nursing mothers.
Glucosylceramide synthase inhibitor.
See Contraindications. Increased risk of arrhythmias with concomitant CYP2D6 inhibitors (eg, paroxetine, terbinafine) or CYP3A inhibitors (eg, ketoconazole, fluconazole); adjust dose based on metabolizer status, type of inhibitor, or degree of hepatic impairment (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): not recommended. Concomitant digoxin; reduce digoxin dose by 30% and monitor. Potentiates P-gp or CYP2D6 substrates (eg, metoprolol); monitor and consider reducing dose of these drugs.
Fatigue, headache, nausea, diarrhea, back pain, pain in extremities, upper abdominal pain; ECG changes, arrhythmias.
Blister card (14 caps)—1, 4