Starting Cerdelga

Cerdelga is the ONLY first-line oral therapy for most adults with Gaucher disease type 1 indicated for the long-term treatment of both naive and switch patients.^1,2 Learn more about patient eligibility, dosing, and safety.

Determining patients’ CYP2D6-metabolizer status is straightforward

CYP enzymes play an important role in metabolizing certain drugs, including Cerdelga. To determine patient eligibility, first conduct a simple blood test to identify the patient's CYP2D6 metabolizer status.^1,3

More than 90% of patients are CYP2D6-metabolizer compatible⁴

Cerdelga is indicated for¹:
Cerdelga is indicated for¹:	extensive metabolizers (EMs)	intermediate metabolizers (IMs)	poor metabolizers (PMs)	ultra-rapid metabolizers
Cerdelga is indicated for¹:

Patients with Gaucher disease type 1 should be selected for Cerdelga use based on their CYP2D6-metabolizer status. It is recommended that patient genotypes be established using an FDA-cleared test for determining CYP2D6 genotype.¹

Use of CERDELGA may be contraindicated or require dosage adjustment in certain patients based on their CYP2D6-metabolizer status, concomitant use of CYP2D6 or CYP3A inhibitors, and degree of renal or hepatic impairment.¹ Please see full Prescribing Information for additional details.

A simple blood test can determine eligibility for Cerdelga treatment.

Patient blood draw is performed

Lab results are processed

Results include the patient's CYP2D6 genotype and metabolizer status

Results usually sent directly to the referring physician

Connect with a
Representative

Request a visit to get answers
to your questions.

Request a rep

PATIENT SUPPORT

We are here to help your patients.

Learn more about CareConnectPSS^®

Prescribing Cerdelga and Recommended Dosing

Cerdelga is the ONLY first-line oral therapy for most adults with Gaucher disease type 1,
indicated for the long-term treatment of both naive and switch patients^1,2

Cerdelga may be taken once or twice daily.¹

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; QD=once daily.

Cerdelga can be prescribed to both naive patients and patients who have been previously or are currently being treated with ERT.¹
Patients can switch to Cerdelga in as little as 24 hours after their last ERT infusion.¹
Dosing should be adjusted based on CYP2D6-metabolizer status, renal/hepatic impairment, and potential drug interactions.¹

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

Safety Profile

Contraindications¹

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.

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

Drug Interactions¹:

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.

Prevention and Management Strategies of Drug Interactions Affecting Cerdelga Based on CYP2D6 Metabolizer Status and Concomitant Interacting Drug¹

RECOMMENDED CERDELGA DOSAGE: CYP2D6-METABOLIZER STATUS

RECOMMENDED CERDELGA DOSAGE: CYP2D6-METABOLIZER STATUS	EM	IM	PM
Strong or moderate CYP2D6 inhibitor concomitantly with strong CYP3A inhibitor	Contrain- dicated	Contraindicated	Contraindicated
Strong or moderate CYP2D6 inhibitor concomitantly with moderate CYP3A inhibitor	Contraindicated	Contraindicated	Avoid co- administration*
Strong CYP2D6 inhibitor eg, paroxetine	84 mg once daily	84 mg once daily	84 mg once daily
Moderate CYP2D6 inhibitor eg, terbinafine	84 mg once daily	84 mg once daily	84 mg once daily
Weak CYP2D6 inhibitor	84 mg twice daily	84 mg twice daily	84 mg once daily
Strong CYP3A inhibitor eg, ketoconazole	84 mg once daily	Contraindicated	Contraindicated
Moderate CYP3A inhibitor eg, fluconazole	84 mg once daily	Avoid co- administration	Avoid co- administration
Weak CYP3A inhibitor	84 mg twice daily	84 mg twice daily	Avoid co- administration
Strong CYP3A inducer	Avoid co- administration	Avoid co- administration	Avoid co- administration

*No effect of CYP2D6 inhibitor due to little or no CYP2D6 activity in CYP2D6 PMs.

Prevention and Management Strategies of Drug Interactions Affecting Other Drugs^1,5

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)	Measure serum digoxin concentrations before initiating Cerdelga. Reduce digoxin dose by 30% and continue monitoring.
Other P-gp substrates (eg, 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 (eg, nortriptyline, amitriptyline, imipramine); phenothiazines (eg, 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
In patients with long QT syndrome
In combination with class IA and class III antiarrhythmic medications

Pregnancy and Lactation

Available data on Cerdelga use in pregnant women includes 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.

Patients With Renal or Hepatic Impairment

Avoid Cerdelga in EMs with end-stage renal disease and 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.

Pediatric Patients

The safety and effectiveness of Cerdelga have not been established in children.

For more information, please click here to download the Cerdelga PI.