Important Safety Information: Certain patients should not use CERDELGA based on their CYP2D6 metabolizer status due to an increased risk of side effects, including heart problems. Do not use CERDELGA if you are an Extensive Metabolizer (EM) taking a medicine that is a strong or moderate CYP2D6 inhibitor along with another medicine that is a strong or... View more

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.

View Indications and Usage

Determining patients’ CYP2D6-metabolizer status is straightforward and free*

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 patients 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

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—at no cost* to you or your patients through a Sanofi Genzyme-funded program with LabCorp.

Blood testing
Patient blood draw is performed by LabCorp at no cost to the patient*
Lab results
Lab results are processed in approximately 2 weeks
Results include the patient's CYP2D6 genotype
Results include the patient's CYP2D6 genotype and metabolizer status
Results will be sent directly to the referring physician
Results will be sent directly to the referring physician

Order a free* CYP2D6 test. Enroll with LabCorp and request a test. Download the account setup form.

For more information, contact Sanofi Genzyme Medical Information at 1‑800‑745‑4447 (option 2) or 617‑768‑9000 (option 2).

*There is no cost to the patient when the test is performed by one of 1700 LabCorp draw stations. Blood drawn at sites other than LabCorp may result in out-of-pocket expenses. LabCorp and Sanofi Genzyme are not responsible for any expenses related to out-of-pocket drug and infusion-related costs for treatment. The Sanofi Genzyme-sponsored CYP2D6-metabolizer testing LabCorp program does not cover or provide support for the cost of MD office visits/evaluations, nursing services/ observation periods, x-rays, blood work or other testing unrelated to the specific Sanofi Genzyme LabCorp CYP2D6-metabolizer testing program, premedications/other medications, EpiPens, transportation, or other related services. Sanofi Genzyme reserves the right to make eligibility decisions, set program maximums, and rescind, revoke, or amend this program without notice.

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 coad-
ministration*
Strong CYP2D6 inhibitor e.g., paroxetine 84 mg
once daily
  84 mg
once daily
  84 mg
once daily
Moderate CYP2D6 inhibitor e.g., 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 e.g., ketoconazole 84 mg
once daily
  Contraindicated   Contraindicated
Moderate CYP3A inhibitor e.g., fluconazole 84 mg
once daily
  Avoid coad-
ministration
  Avoid coad-
ministration
Weak CYP3A inhibitor 84 mg
twice daily
  84 mg
twice daily
  Avoid coad-
ministration
Strong CYP3A inducer Avoid coad-
ministration
  Avoid coad-
ministration
  Avoid coad-
ministration

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

Prevention and Management Strategies of Drug Interactions Affecting Other Drugs1,5

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 (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
  • 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.

References:
  1. Cerdelga [prescribing information]. Cambridge, MA: Sanofi Genzyme. 2018.
  2. Pleat R, Cox TM, Burrow TA, et al. Stability is maintained in adults with Gaucher disease type 1 switched from velaglucerase alfa to eliglustat or imiglucerase: A sub-analysis of the eliglustat ENCORE trial. Mol Genet Metab Rep. 2016;9:25-28.
  3. Ogu CC, Maxa JL. Drug interactions due to cytochrome P450. Proc (Bayl Univ Med Cent). 2000;13(4):421 -423
  4. Mistry PK, Lukina E, Ben Turkia H, et al. Outcomes after 18 months of eliglustat therapy in treatment-naïve adults with Gaucher disease type 1: the phase 3 ENGAGE trial. Am J Hematol. 2017;92(11):1170–1176.
  5. Data on File. Sanofi Genzyme.