Prescribing guide
Cerdelga (eliglustat)CYP2D6 genotyping, dosing by metabolizer status, CYP2D6 and CYP3A inhibitor tables, ECG warnings and prior authorization criteria for Gaucher disease type 1For prescribers and their offices treating gaucher disease: what the pharmacy needs before it ships, what the prior authorization wants documented, the titration and the monitoring the label requires.
Dispensing gate
No REMS in the label and no boxed warning. CYP2D6 genotype by an FDA-cleared test (EM, IM or PM), a full interaction, hepatic, renal and cardiac review, and prior authorization before the first fill.
Example PA threshold
Cigna example: Gaucher disease type 1; CYP2D6 EM, IM or PM by an approved test; documented deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts, or biallelic pathogenic GBA variants; not for neurological manifestations; specialist prescriber; no concurrent Gaucher therapy.
Monitoring
No scheduled laboratory or ECG monitoring in the label; recheck Table 5 with every new concomitant drug; digoxin level before initiation; counsel on palpitations, fainting and dizziness.
Support line
CareConnect Case Managers 1-800-745-4447, option 3 (Monday to Friday 8 AM to 6 PM EST); Co-Pay Program 1-855-448-6520 for eligible commercial plans; Patient Assistance Program for uninsured or denied patients.
Give your patient their plan
A one-page handout for starting Cerdelga, in plain language: what the first fill waits on, the first dates, who will call and the symptoms to report, with blank lines for the start date and your office's number. The link opens the patient's full first 90 days page, where their dates become calendar entries.
trialfriend.com/p/cerdelgaBefore the first fill: REMS, labs and enrollment
The steps that the pharmacy, the REMS or the drugmaker's program will wait on, in the order they usually need to happen. A first fill of a specialty drug most often stalls on one of these rather than on the plan.
| Step | What it requires | Source |
|---|---|---|
| Genotype CYP2D6 | Select patients by CYP2D6 metabolizer status; the label recommends an FDA-cleared CYP2D6 genotype test. Indicated for EMs, IMs and PMs. URMs may not achieve adequate concentrations; no dosage can be recommended for indeterminate metabolizers. | FDA label |
| Test logistics | Sanofi: a blood draw, with results that will likely include the CYP2D6 genotype and are usually sent directly to the referring provider. | Cerdelga eligibility testing page |
| Reconcile medications | Classify every concomitant drug as a strong, moderate or weak CYP2D6 or CYP3A inhibitor, or a strong CYP3A inducer, and apply section 4, Table 2 and Table 5 for the patient's metabolizer status. | FDA label |
| Hepatic, renal and cardiac status | Contraindications and dose depend on hepatic impairment (section 8.7); avoidance depends on renal impairment (section 8.6). Avoid in pre-existing cardiac disease and long QT syndrome (section 5.1). | FDA label |
| Enroll in CareConnect | Send the patient a digital consent link, or have them call a Case Manager at 1-800-745-4447 (English option 3, Spanish option 7). Lines are open Monday to Friday, 8 AM to 6 PM EST; or email info@CareConnectPSS.com. | CareConnect for HCPs |
| Benefits | For patients starting treatment, CareConnect assists with insurance verification and explains coverage; it also helps with insurance changes. | CareConnect for HCPs |
| Ordering and refills | Rare Disease Products can be purchased through authorized distributors, specialty pharmacies or directly from Sanofi. Product Services, 1-800-745-4447 option 1 or CO@Sanofi.com, provides refill reminders where appropriate. | CareConnect for HCPs |
| Package size | 84mg capsules: carton of 56 (4 blister wallets of 14, NDC 58468-0220-1) or carton of 14 (NDC 58468-0220-2). A 56-capsule carton is 28 days at twice daily or 56 days at once daily. Store at 20°C to 25°C. | FDA label |
| Medication Guide | The carton says to dispense the enclosed Medication Guide to each patient; advise the patient to read it. | FDA label |
| Co-Pay Program | Commercial only: 100% of eligible out-of-pocket drug costs up to a program maximum. Runs January 1 to December 31; re-enrollment may be needed yearly. Application fax 1-800-750-9839; questions 1-855-448-6520. | Co-Pay Program application |
| Co-Pay exclusions | Excludes prescriptions paid in whole or in part by Medicaid, Medicare (including Part D), Medigap, VA, DoD, TRICARE or other federal or state programs. | Co-Pay Program application |
| Patient Assistance Program | Certain Sanofi therapies at no cost for eligible patients without insurance or who cannot access the product under their plan; described by Sanofi as temporary until coverage is secured. | Cerdelga support page |
Prior authorization criteria and what to document
One public policy as the example: Cigna, July 15, 2026. Approval one year. This policy (Drug Coverage Policy IP0441) cites the January 2024 Cerdelga label, which is the current one. Its July 15, 2026 revision added the rule about neurological symptoms, and it dropped an age 18 rule in December 2024. It is here as an example of what a plan asks for, not as a rule.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis | Gaucher disease type 1 | Diagnosis in the note | Cigna policy |
| CYP2D6 status | Extensive, intermediate or poor metabolizer as detected by an approved test | CYP2D6 genotype report | Cigna policy |
| Diagnosis, enzyme route | Demonstration of deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts [documentation required] | Enzyme assay report | Cigna policy |
| Diagnosis, genetic route | Molecular genetic test showing biallelic pathogenic GBA variants [documentation required]; either route qualifies | Genetic test report | Cigna policy |
| Use | Not for the management of neurological manifestations (examples: abnormal ocular movement, auditory impairment, cognitive impairment, seizures); added July 15, 2026 | Treatment goals in the note | Cigna policy |
| Prescriber | Geneticist, endocrinologist, metabolic disorder subspecialist or a physician who specializes in Gaucher disease or related disorders, or in consultation with one | Prescriber specialty or consult note | Cigna policy |
| Concurrent therapy | Not medically necessary with other approved Gaucher therapies (examples: Cerezyme, Elelyso, Vpriv, Zavesca) | Current medication list, with the last ERT date if switching | Cigna policy |
| Approval | 1 year; no age criterion since December 2024 | Updated criteria at each review | Cigna policy |
Cerdelga dosing and titration
| When | Label | Source |
|---|---|---|
| EMs and IMs | 84mg orally twice daily. | FDA label |
| PMs | 84mg orally once daily. | FDA label |
| Reduce to once daily: EMs | Without hepatic impairment: taking a strong or moderate CYP2D6 inhibitor, or a strong or moderate CYP3A inhibitor. Mild (Child-Pugh A) impairment: taking a weak CYP2D6 inhibitor, or a strong, moderate or weak CYP3A inhibitor. | FDA label |
| Reduce to once daily: IMs | Without hepatic impairment, taking a strong or moderate CYP2D6 inhibitor. | FDA label |
| Administration | Swallow whole, preferably with water; do not crush, dissolve or open. With or without food. Avoid grapefruit and grapefruit juice (strong CYP3A inhibitors). | FDA label |
| Missed dose | Take the prescribed dose at the next scheduled time; do not double the next dose. | FDA label |
| Switch from ERT | May be administered 24 hours after the last dose of imiglucerase, velaglucerase alfa or taliglucerase alfa. | FDA label |
| Renal impairment | EMs: no adjustment with mild, moderate or severe impairment (eCLcr at least 15 mL/min); avoid in ESRD. IMs and PMs: avoid with any degree of renal impairment. | FDA label |
| Hepatic impairment | EMs: contraindicated in moderate or severe impairment, and in mild impairment with a strong or moderate CYP2D6 inhibitor; otherwise no adjustment in mild impairment except as in Table 2. IMs and PMs: contraindicated with any degree. | FDA label |
| Pediatric and geriatric | Safety and effectiveness not established in pediatric patients. Studies did not include sufficient numbers of subjects 65 and over. | FDA label |
| Trial dosing | Trials 1 and 2 titrated from 42mg twice daily by trough concentration (to 84mg, and in Trial 2 also 127mg, twice daily); the labeled regimen is fixed by metabolizer status. | FDA label |
Monitoring the Cerdelga label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Before prescribing | CYP2D6 genotype by an FDA-cleared test | EM, IM or PM sets dose and the applicable interaction rules; URM and indeterminate status fall under the label's Limitations of Use | FDA label |
| Before prescribing | Cardiac history: congestive heart failure, recent acute MI, bradycardia, heart block, ventricular arrhythmia, long QT syndrome | Avoid use; not studied in pre-existing cardiac conditions. The label sets no ECG schedule | FDA label |
| Before initiating, if on digoxin | Serum digoxin concentration | Reduce the digoxin dose by 30% and continue monitoring | FDA label |
| Each new concomitant drug | CYP2D6 and CYP3A inhibitor or inducer class | Contraindicated, avoid, reduce to once daily or continue, per Table 5 and metabolizer status | FDA label |
| Any time | Palpitations, fainting, dizziness | Advise patients to inform their healthcare provider of new symptoms | FDA label |
| Ongoing | Other P-gp or CYP2D6 substrates | Monitor therapeutic drug concentrations as indicated, or consider reducing the concomitant drug's dosage and titrating to clinical effect | FDA label |
| Overdose | One healthy subject at about 21 times the recommended dose: dizziness with disequilibrium, hypotension, bradycardia, nausea, vomiting | Observe and give symptomatic and supportive treatment; hemodialysis unlikely to help | FDA label |
Cerdelga drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Strong or moderate CYP2D6 inhibitor (Table 9: paroxetine observed in EMs; terbinafine PBPK-predicted) | EMs and IMs: reduce to 84mg once daily. PMs: continue 84mg once daily (no effect expected) | FDA label |
| Weak CYP2D6 inhibitor | EMs and IMs: continue 84mg twice daily. PMs: continue 84mg once daily | FDA label |
| Strong CYP3A inhibitor (Table 9: ketoconazole observed in EMs, PBPK-predicted in IMs and PMs) | EMs: reduce to 84mg once daily. IMs and PMs: contraindicated | FDA label |
| Moderate CYP3A inhibitor (Table 9: fluconazole, PBPK-predicted) | EMs: reduce to 84mg once daily. IMs and PMs: avoid coadministration | FDA label |
| Weak CYP3A inhibitor | EMs and IMs: continue 84mg twice daily. PMs: avoid coadministration | FDA label |
| Strong or moderate CYP2D6 inhibitor with a strong CYP3A inhibitor | Contraindicated in EMs, IMs and PMs | FDA label |
| Strong or moderate CYP2D6 inhibitor with a moderate CYP3A inhibitor | EMs and IMs: contraindicated. PMs: avoid coadministration | FDA label |
| Exposure changes in EMs (Table 9) | Eliglustat AUC up 8.4-fold with paroxetine and 4.4-fold with ketoconazole; 24.2-fold predicted by PBPK modeling for paroxetine with ketoconazole | FDA label |
| Strong CYP3A inducer (studied: rifampin) | Avoid coadministration in all metabolizer groups; rifampin lowered eliglustat exposure by 90% to 95% in Table 9 | FDA label |
| Grapefruit and grapefruit juice | Avoid; the label classes them as strong CYP3A inhibitors | FDA label |
| Class IA or Class III antiarrhythmics | Avoid use in combination (examples: quinidine, procainamide, amiodarone, sotalol) | FDA label |
| Digoxin (P-gp substrate) | Digoxin Cmax up 1.7-fold and AUC up 1.5-fold; measure the level before initiating, reduce the digoxin dose by 30%, continue monitoring | FDA label |
| CYP2D6 substrates | Metoprolol AUC up 2.3-fold in EMs and 1.6-fold in IMs; monitor drug concentrations as indicated or consider reducing the concomitant dose | FDA label |
| Oral contraceptives, gastric pH modifiers | No change in norethindrone or ethinyl estradiol exposure; no clinically significant change in eliglustat with antacids or pantoprazole | FDA label |
| Pregnancy | 20 pregnancies in clinical development and a small number of postmarketing reports: insufficient to assess risk. Rats: developmental abnormalities at 6 times the recommended human dose; none in rabbits at 10 times | FDA label |
| Lactation | No human data; present in rat milk. Weigh the benefits of breastfeeding against the mother's clinical need and potential adverse effects | FDA label |
Why a first fill stalls, and the fix
- Prior authorization pending or deniedThe Cigna policy below asks for an approved test showing you are a CYP2D6 extensive, intermediate or poor metabolizer. It also asks for a lab report or genetic test that confirms Gaucher disease type 1.
- An ultra-rapid or undetermined CYP2D6 resultThe label says ultra-rapid metabolizers may not reach a working drug level, and that no dose can be recommended when the result is indeterminate. Your doctor decides which treatment fits you.
- The pharmacy flags a drug interactionDepending on your metabolizer type, the label rules out some medicine combinations, says to avoid others, or lowers the dose. Your doctor reviews the list and decides.
- The doctor is not a specialistCigna asks that Cerdelga be prescribed by, or with advice from, a geneticist, endocrinologist, metabolic specialist or a doctor who specializes in Gaucher disease or related disorders.
- The request mentions brain or nerve symptomsCigna does not cover Cerdelga to manage neurological symptoms such as seizures or abnormal eye movement. The label covers Gaucher disease type 1 only.
- Also taking another Gaucher medicineCigna treats Cerdelga used together with Cerezyme, Elelyso, Vpriv or Zavesca as not medically necessary. Your doctor decides which treatment fits you.
- A copay you cannot payCommercial insurance: the CareConnect Co-Pay Program pays 100% of eligible out-of-pocket drug costs up to a program maximum. Medicare, Medicaid, VA, TRICARE and other government coverage are excluded.
- A new calendar yearThe Co-Pay Program runs from January 1 through December 31. Sanofi says you may need to re-enroll each year to confirm you still qualify.
- No insurance, or the plan will not cover itThe CareConnect Patient Assistance Program may provide certain Sanofi therapies at no cost. Sanofi calls it a temporary solution until coverage can be secured. Call 1-800-745-4447, option 3.
CareConnect (CareConnect Personalized Support Services)
- A Case Manager for health insurance, financial help, care coordination and life changes such as travel, moving or new insurance. For Spanish, press 7
- A Patient Education Liaison with a nursing or genetic counseling background, for disease and treatment education and how the disease is passed on in families Cerdelga support page
- The CareConnect Co-Pay Program for commercial insurance, paying 100% of eligible out-of-pocket drug costs up to a program maximum, with questions answered at 1-855-448-6520 Co-Pay Program application
- Co-pay help is not open to people whose prescriptions are paid by Medicare, Medicaid, VA, Department of Defense, TRICARE or other federal or state programs Co-Pay Program application
- The CareConnect Patient Assistance Program, certain Sanofi therapies at no cost for eligible people without insurance or whose plan will not cover them
- Help with insurance verification when you start treatment, and with insurance changes later
Questions prescribers' offices ask about Cerdelga
What is the Cerdelga dose by CYP2D6 metabolizer status?
The current label (DailyMed March 2024, revised 1/2024) gives 84mg twice daily for CYP2D6 EMs and IMs and 84mg once daily for PMs. Select patients with an FDA-cleared CYP2D6 genotype test. URMs may not reach therapeutic concentrations, and no dosage can be recommended for indeterminate metabolizers.
Which CYP2D6 and CYP3A inhibitor combinations are contraindicated with Cerdelga?
Section 4 of the label revised 1/2024 contraindicates 3 inhibitor patterns: a strong or moderate CYP2D6 inhibitor with a strong or moderate CYP3A inhibitor in EMs and IMs; a strong CYP3A inhibitor in IMs and PMs; and a strong or moderate CYP2D6 inhibitor in EMs with mild hepatic impairment. It also contraindicates moderate or severe hepatic impairment in EMs and any hepatic impairment in IMs and PMs. The stated reason is arrhythmia risk from PR, QTc and/or QRS prolongation.
When is Cerdelga reduced to 84mg once daily?
Table 2 of the label revised 1/2024 reduces 84mg twice daily to once daily in 3 settings. These are EMs without hepatic impairment on a strong or moderate CYP2D6 inhibitor or a strong or moderate CYP3A inhibitor; EMs with mild (Child-Pugh A) impairment on a weak CYP2D6 inhibitor or any CYP3A inhibitor; and IMs without hepatic impairment on a strong or moderate CYP2D6 inhibitor.
Does the Cerdelga label require ECG monitoring?
No ECG schedule is set in the label revised 1/2024, which predicts mean PR, QRS and QTcF increases of 22, 7 and 13 msec at an eliglustat concentration of 500 ng/mL. At 8 times the recommended dose (mean peak 237 ng/mL) there was no clinically relevant QT/QTc prolongation. Avoid use in pre-existing cardiac disease, long QT syndrome, and with Class IA or Class III antiarrhythmics.
What are the Cerdelga prior authorization criteria?
The Cigna policy shown here, IP0441 effective July 15, 2026, approves 1 year for Gaucher disease type 1 in a CYP2D6 EM, IM or PM detected by an approved test. It also requires documented deficient beta-glucocerebrosidase activity or biallelic pathogenic GBA variants, no use for neurological manifestations, and a specialist prescriber. Concurrent Cerezyme, Elelyso, Vpriv or Zavesca is not covered.
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Sources
- DailyMed - CERDELGA- eliglustat capsule (updated March 3, 2024, SPL version 13, prescribing information revised 1/2024, Medication Guide issued January 2024), Genzyme Corporation, via DailyMed, 2024-03-03.
- Support and Resources | Cerdelga® (eliglustat) Capsules, Sanofi, 2024-07.
- How to Get Started on Cerdelga, Cerdelga Patient Checklist (MAT-US-2204844-v1.0-07/2022), Sanofi, 2022-07.
- Cerdelga® Eligibility Testing | For US HCPs, Sanofi, 2025-07.
- CareConnect for Healthcare Professionals, Sanofi, 2024-11.
- CareConnect Personalized Support Services Co-Pay Program Application, Substrate Reduction Therapy (MAT-US-2506609-v1.0-06/2025), Sanofi, 2025-06.
- Gaucher Disease – Substrate Reduction Therapy – Cerdelga, Drug Coverage Policy IP0441, Cigna, 2026-07-15.
- NDA 205494/S-03 supplement approval letter, long-term extension results, renal and hepatic impairment dosage recommendations, PLLR format, FDA, 2018-08-29.
- NDA 205494 approval letter, Cerdelga (eliglustat) capsules, FDA, 2014-08-19.
A reference drawn from the March 3, 2024 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 11, 2026. Labels and policies change; the label on DailyMed and the plan's current policy govern. Trial Friend is not a medical provider. It reports what these documents say and does not judge whether a drug is safe or right for any patient; that is the prescriber's decision. Not a substitute for the prescribing information.