Cerdelga Dosing| Cerdelga® (eliglustat) Capsules

The Recommended Dosage of Cerdelga Is Based on a Patient's CYP2D6 Metabolizer Status

Cerdelga may be taken once or twice daily¹

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

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.

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.

Drug Interactions

Cerdelga (eliglustat) 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 of Drug Interactions Affecting Cerdelga Based on CYP2D6 Metabolizer Status and Concomitant Interacting Drug¹

*No 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.

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).

Ready to SWITCH eligible adult patients to Cerdelga?

Cerdelga was proven noninferior to ERT¹

See Trial Results

Ready to START eligible patients on Cerdelga?

Cerdelga is proven effective in treatment-naïve adult patients¹

See Trial Results

Indication and Usage

CERDELGA is indicated for the long-term treatment of adult patients with Gaucher disease type 1 (GD1) who are CYP2D6 extensive metabolizers (EMs), intermediate metabolizers (IMs), or poor metabolizers (PMs) as detected by an FDA-cleared test.

Limitations of Use:

Patients who are CYP2D6 ultra-rapid metabolizers (URMs) may not achieve adequate concentrations of CERDELGA to achieve a therapeutic effect.
A specific dosage cannot be recommended for those patients whose CYP2D6 genotype cannot be determined (indeterminate metabolizers).

Important Safety Information

CONTRAINDICATIONS

CERDELGA is contraindicated in the following patients based on CYP2D6 metabolizer status due to the risk of cardiac arrhythmias from prolongation of the PR, QTc, and/or QRS cardiac intervals:

Extensive Metabolizers (EMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, EMs with moderate or severe hepatic impairment, or EMs with mild hepatic impairment and taking a strong or moderate CYP2D6 inhibitor.
Intermediate Metabolizers (IMs) taking a strong or moderate CYP2D6 inhibitor concomitantly with a strong or moderate CYP3A inhibitor, IMs taking a strong CYP3A inhibitor, or IMs with any degree of hepatic impairment.
Poor Metabolizers (PMs) taking a strong CYP3A inhibitor, or PMs with any degree of hepatic impairment.

WARNINGS AND PRECAUTIONS

CERDELGA is predicted to cause increases in ECG intervals (PR, QTc, and QRS) at substantially elevated plasma concentrations and may increase risk of cardiac arrhythmias. Use of CERDELGA is contraindicated, to be avoided, or requires dosage adjustment in patients taking CYP2D6 or CYP3A inhibitors, depending on CYP2D6 metabolizer status, type of inhibitor, or degree of hepatic impairment. Avoid use of CERDELGA in patients with pre-existing cardiac disease, long QT syndrome, or in combination with Class IA or Class III antiarrhythmic medications.

ADVERSE REACTIONS

The most common adverse reactions (≥10%) to CERDELGA include: fatigue, headache, nausea, diarrhea, back pain, pain in extremities, and upper abdominal pain.

DRUG INTERACTIONS

Coadministration of CERDELGA with CYP2D6 or CYP3A inhibitors may increase eliglustat concentrations, which may increase the risk of cardiac arrhythmias from prolongations of the PR, QTc, and/or QRS cardiac interval. Use of CERDELGA is contraindicated, to be avoided, or may require dosage adjustment depending on the concomitant drug and CYP2D6 metabolizer status. See section 7 of the full Prescribing Information for more details and other potentially significant drug interactions.

USE IN SPECIFIC POPULATIONS

Available data on the use of CERDELGA in pregnant women is not sufficient to assess drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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.

Use of CERDELGA in patients with renal impairment is based on the patient’s CYP2D6 metabolizer status. Avoid use of CERDELGA in EMs with end-stage renal disease (ESRD), and IMs and PMs with any degree of renal impairment.

Use of CERDELGA is contraindicated or may require dosage adjustment in patients with hepatic impairment based on CYP2D6 metabolizer status, concomitant use of CYP2D6 or CYP3A inhibitors, and degree of hepatic impairment.

Please see accompanying full Prescribing Information.

References: 1. Cerdelga [prescribing information]. Cambridge, MA: Sanofi. 2. Data on file. Sanofi.

See Safety