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The recommended dosage of Cerdelga is based on a patient's CYP2D6 metabolizer status
Cerdelga may be taken once or twice daily1
Cerdelga 84 mg BID in CYP2D6 EMs and IMs
Also in:
- CYP2D6 EMs with mild, moderate, or severe renal impairment
- CYP2D6 EMs with mild hepatic impairment
Cerdelga 84 mg QD in CYP2D6 PMs
Also in:
- CYP2D6 EMs and IMs taking strong or moderate CYP2D6 inhibitors
- CYP2D6 EMs taking strong or moderate CYP3A inhibitors
- CYP2D6 EMs with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate, or weak CYP3A inhibitor
BID=twice daily; EMs=extensive metabolizers; IMs=intermediate metabolizers; PMs=poor metabolizers; QD=once daily.
- Cerdelga can be prescribed to both naïve adult patients and adult patients who have been previously or are currently being treated with ERT1
- Patients can switch to Cerdelga in as little as 24 hours after their last ERT infusion1
- Dosing should be adjusted based on CYP2D6 metabolizer status, renal/hepatic impairment, and potential drug interactions1
ERT=enzyme replacement therapy.
Guidance for taking Cerdelga
Cerdelga is a capsule that must be taken whole1
Cerdelga can be taken with or without food1
Patients should avoid eating grapefruit or drinking grapefruit juice1
If patients miss a dose, they should take the prescribed dose at the next scheduled time; they should not double the next dose1
Cerdelga contraindications
Due to the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals, Cerdelga is contraindicated in the following patients based on CYP2D6 metabolizer status1:
EMs
- Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor
- Moderate or severe hepatic impairment
- Mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor
IMs
- Taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor
- Taking a strong CYP3A inhibitor
- Any degree of hepatic impairment
PMs
- Taking a strong CYP3A inhibitor
- Any degree of hepatic impairment
EMs=extensive metabolizers; IMs=intermediate metabolizers; PMs=poor metabolizers.
Cerdelga Drug interactions
- Cerdelga is a CYP2D6 and CYP3A substrate
- Drugs that inhibit CYP2D6 and CYP3A may significantly increase the exposure to eliglustat, which may increase the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac interval
- Cerdelga may be contraindicated or modification of Cerdelga dose may be needed, depending on metabolizer status
- Eliglustat is an inhibitor of P-gp and CYP2D6. Coadministration of Cerdelga with drugs that are substrates for P-gp or CYP2D6 may result in increased concentrations of the concomitant drug
P-gp=p-glycoprotein.
Prevention and management strategies
Prevention and management strategies of drug interactions affecting Cerdelga based on CYP2D6 metabolizer status and concomitant interacting drug1
Recommended Cerdelga dosage: CYP2D6 metabolizer status | EM | IM | PM |
Strong or moderate CYP2D6 inhibitor concomitantly with strong CTP3A inhibitor | Contraindicated | Contraindicated | Contraindicated |
Strong or moderate CYP2D6 inhibitor concomitantly with moderate CTP3A inhibitor | Contraindicated | Contraindicated | Avoid coadministrationa |
Strong CYP2D6 inhibitor, e.g. paroxetine | 84mg once daily | 84mg once daily | 84mg once daily |
Moderate CYP2D6 inhibitor, e.g. terbinafine | 84mg once daily | 84mg once daily | 84mg once daily |
Weak CYP2D6 inhibitor | 84mg twice daily | 84mg twice daily | 84mg once daily |
Strong CYP3A inhibitor, e.g. ketoconazole | 84mg once daily | Contraindicated | Contraindicated |
Moderate CYP3A inhibitor, e.g. fluconazole | 84mg once daily | Avoid coadministration | Avoid coadministration |
Weak CYP3A inhibitor | 84mg twice daily | 84mg twice daily | Avoid coadministration |
Strong CYP3A inducer | Avoid coadministration | Avoid coadministration | Avoid coadministration |
aNo effect of CYP2D6 inhibitor due to little or no CYP2D6 activity in CYP2D6 PMs.
Prevention and management strategies of drug interactions affecting other drugs1,2
Coadministration of Cerdelga may increase concentrations of drugs that are substrates of P-gp or CYP2D6 and may increase the risk of toxicity of these drugs.
Drug class or drug name | Clinical recommendations |
Digoxin (P-gp substrate) | Monitor serum digoxin concentrations before initiating Cerdelga. Reduce digoxin dose by 30% and continue monitoring. |
Other P-gp substrates (e.g., phenytoin, colchicine, dabigatran etexilate) | Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the concomitant drug and titrate to clinical effect. |
CYP2D6 substrates: metoprolol; tricyclic antidepressants (e.g., nortriptyline, amitriptyline, imipramine); phenothiazines (e.g., perphenazine, chlorpromazine) |
Use in specific populations1
Pre-existing Cardiac Conditions
Because Cerdelga is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated plasma concentrations and may increase the risk of cardiac arrhythmias, avoid use:
- In patients with pre-existing cardiac disease (congestive heart failure, recent acute myocardial infarction, bradycardia, heart block, and ventricular arrhythmia)
- In patients with long QT syndrome
- In combination with class IA and class III antiarrhythmic medications
Patients with Renal or Hepatic Impairment
- Avoid Cerdelga in EMs with end-stage renal disease and in IMs and PMs with any degree of renal impairment
- Cerdelga is contraindicated in EMs with moderate or severe hepatic impairment and in EMs with mild hepatic impairment taking a strong or moderate CYP2D6 inhibitor
- Reduce dosage in EMs with mild hepatic impairment taking a weak CYP2D6 inhibitor or a strong, moderate, or weak CYP3A inhibitor
- Cerdelga is contraindicated in IMs and PMs with any degree of hepatic impairment
Pregnancy and Lactation
-
Available data on Cerdelga use in pregnant women include 20 pregnancies that occurred during the clinical development program and a small number of post-marketing case reports. These data are not sufficient to assess drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes
-
Based on animal data, Cerdelga may cause fetal harm or be present in human milk
-
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Cerdelga and any potential adverse effects on the breastfed child from Cerdelga or from the underlying maternal condition
Pediatric Patients
The safety and effectiveness of Cerdelga have not been established in children.
For more information, please download the Cerdelga Prescribing Information (PI).
Indication
References: 1. Cerdelga (eliglustat). Prescribing Information. Sanofi. 2. Data on file. Sanofi.