Your first 90 days
Your first 90 days on Cerdelga for Gaucher disease
What happens before the first fill, the days that matter, the label's rules and who to call, from the label, the drugmaker's own program and one insurer's written rules.
Cerdelga is a daily capsule, not an infusion, and the work comes before the first dose. A gene test decides whether you can take it and how often. Your full medicine list, your liver and kidneys, and your heart history all change what the label allows. This page lays out the first 90 days from the FDA label, Sanofi's Cerdelga and CareConnect pages, and one insurer's written rules.
What has to happen before the first bottle ships
Cerdelga has no REMS in its label, so the first fill waits on a CYP2D6 gene test, a full medicine and health review, and an insurance approval. These are the 7 things in the way, in order.
A CYP2D6 gene test
The label says to select patients with an FDA-cleared CYP2D6 genotype test.
- Cerdelga is approved for extensive, intermediate and poor metabolizers, the names for how fast your body breaks it down.FDA label
A result that fits the label
Ultra-rapid metabolizers may not reach a drug level high enough to work, according to the label.
- For people whose result cannot be determined, the label says no dose can be recommended.FDA label
How the test is done
Sanofi describes it as a blood draw that a lab processes.
- Results usually go straight to the doctor who ordered the test.Cerdelga eligibility testing page
Your full medicine list
Bring every prescription drug, over-the-counter drug, vitamin and herbal supplement.
- Sanofi's checklist says certain medicines may affect how Cerdelga breaks down.Cerdelga patient checklist
Your liver, kidney and heart history
The label bases the dose, and whether Cerdelga can be used at all, on liver and kidney problems.
- It also says to tell your doctor about heart problems, including long QT syndrome.FDA label
A confirmed diagnosis
The Cigna policy shown below asks for a blood or skin cell test showing low enzyme activity.
- A genetic test showing changes in both copies of the GBA gene also counts.Cigna policy
Signing up with CareConnect
Sanofi says the program is free, voluntary and confidential.
- You can enroll online or call 1-800-745-4447, option 3, with questions.Cerdelga support page
The days that matter
Counted from the first capsule. Refill days come from the 56-capsule carton, which holds 28 days at twice a day and 56 days at once a day. Type your first-dose date and the tiles become real dates you can add to your calendar.
The tiles below count days from a first dose. Enter the date of yours, or the date you expect, and each tile becomes a real date on your calendar.
The date stays on your device. It is not sent to Trial Friend or anyone else. The calendar file works with Apple, Google and Outlook calendars.The CYP2D6 gene test
Your doctor orders the gene test and waits for the result.
- No source sets how long the result takes, so ask the office when to expect it.
Medicine and health review
Your doctor checks your metabolizer type against your medicines, liver, kidneys and heart history.
- The label's dose tables depend on all of these together.
Insurance approval and the first carton
For someone just starting treatment, Sanofi says CareConnect can help verify insurance and explain your coverage.
- Each insurer works on its own timeline.
First capsule
You take 84mg once or twice a day, as your doctor prescribed.
- If you are switching from enzyme infusions, the label allows Cerdelga 24 hours after the last infusion.
First refill at twice a day
A 56-capsule carton holds 28 days of capsules at 84mg twice a day.
- Each carton comes as 4 blister cards of 14 capsules, and a 14-capsule carton also exists.
Refill, or first refill at once a day
At 84mg once a day, a 56-capsule carton lasts 56 days.
- Tell your doctor about any new medicine before you start it, as the Medication Guide asks.
Third refill at twice a day
The label sets no blood test or heart test schedule for these 90 days.
- In the main trial of untreated patients, spleen size was measured at 9 months, past this point.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Cerdelga label records, dated by the FDA, with a plain note on what each one meant for a patient. Older references and handouts can lag these by months.
Current label dated March 3, 2024, read from the FDA's label database today. FDA label
- March 2024
DailyMed posted version 13 of the label, the current one, with the text revised in January 2024. It lists no recent major changes.FDA label
- August 2018
The FDA added dose advice for people with kidney or liver impairment, based on new studies. It also added long-term trial results and rewrote the pregnancy and breastfeeding sections in the newer format.FDA letter
- August 2014
The FDA first approved Cerdelga for adults with Gaucher disease type 1 who are CYP2D6 extensive, intermediate or poor metabolizers, as detected by an FDA-cleared test.FDA approval letter
How the label says to take it
The parts of the prescribing information and the patient leaflet that come up in the first 3 months, in plain words.
- Dose by metabolizer type
The label sets 84mg twice a day for extensive and intermediate metabolizers.
- Poor metabolizers take 84mg once a day.
- Your doctor may change the dose if needed.FDA label
- Swallow capsules whole
The Medication Guide says to take capsules whole, preferably with water, and not to open, crush or dissolve them.
- Cerdelga can be taken with or without food.FDA label
- No grapefruit
The Medication Guide says to avoid eating or drinking grapefruit products while taking Cerdelga.
- Grapefruit products can increase the amount of Cerdelga in your body.FDA label
- If you miss a dose
The Medication Guide says to take the next dose at the usual time.
- It says not to take two doses at the same time.FDA label
- If you take too much
The Medication Guide says to call your doctor or go to the nearest hospital emergency room right away.FDA label
- New medicines
Tell your doctor about any new medicine before you start it.
- The Medication Guide names St. John's Wort and medicines for fungal infections, tuberculosis, seizures, heart conditions, high blood pressure and depression.FDA label
- Why other medicines matter
Some medicines slow CYP2D6 or CYP3A, the enzymes that clear Cerdelga, and raise its level.
- Depending on your metabolizer type, the label rules out the combination, says to avoid it, or lowers the dose to once a day.FDA label
- Liver problems
The label rules out Cerdelga for intermediate and poor metabolizers with any degree of liver impairment.
- For extensive metabolizers, it rules out moderate or severe impairment, and mild impairment combined with a strong or moderate CYP2D6 inhibitor.FDA label
- Kidney problems
The label says to avoid Cerdelga in intermediate and poor metabolizers with any degree of kidney impairment.
- For extensive metabolizers, it says to avoid Cerdelga in end-stage kidney disease.FDA label
- Switching from infusions
For people on imiglucerase, velaglucerase alfa or taliglucerase alfa, the label says Cerdelga may be given 24 hours after the last infusion.
- Your doctor plans the switch.FDA label
- Pregnancy
It is not known if Cerdelga will harm an unborn baby.
- The label says data from 20 pregnancies in the trials and a small number of later reports are not enough to judge the risk.
- Tell your doctor if you are pregnant or planning to be.FDA label
- Breastfeeding
It is not known if Cerdelga passes into breast milk.
- The Medication Guide says you and your doctor decide whether you take Cerdelga or breastfeed, and that you should not do both.FDA label
- Storage
Store Cerdelga at room temperature, between 68°F and 77°F (20°C and 25°C).
- Keep it out of the reach of children.FDA label
What the label says to act on
The symptoms the label singles out, and what it tells patients and prescribers to do about each. If any of these happen, the label's instruction is the one to follow, with your care team.
Palpitations, fainting or dizziness
Cerdelga used with certain other medicines may cause changes in the heart's electrical activity and an irregular heartbeat.
- The Medication Guide says to tell your doctor if you have these new symptoms.FDA label
Heart conditions the label warns about
The label says to avoid Cerdelga in people with heart failure, a recent heart attack, a slow heart rate, heart block, ventricular arrhythmia or long QT syndrome.
- Cerdelga was not studied in people with existing heart conditions.FDA label
Heart rhythm medicines
The label says to avoid Cerdelga together with Class IA or Class III heart rhythm medicines.
- Its examples are quinidine, procainamide, amiodarone and sotalol.FDA label
Medicines that raise Cerdelga levels
The label's Table 9 lists higher Cerdelga levels with paroxetine, terbinafine, ketoconazole and fluconazole.
- Some figures were measured in studies and others were predicted by modeling.
- Higher levels may raise the risk of heart rhythm changes.FDA label
Medicines that lower Cerdelga levels
Rifampin lowered Cerdelga levels by 90% or more in the label's study, which may make Cerdelga work less well.
- The label says to avoid medicines of this kind, called strong CYP3A inducers.FDA label
Medicines that Cerdelga raises
Cerdelga can raise levels of digoxin and of medicines such as metoprolol.
- The label asks doctors to check digoxin levels before starting Cerdelga and to lower the digoxin dose by 30%.FDA label
Common side effects
Tiredness, headache, nausea, diarrhea, back pain, pain in the arms or legs and upper stomach pain each affected 10% or more of 126 trial patients.
- Tell your doctor about any side effect that bothers you or does not go away.FDA label
Joint pain in the placebo trial
Among 40 untreated patients, joint pain was reported by 45% on Cerdelga and 10% on placebo.
- Headache was reported by 40% and 30%.FDA label
Why the pharmacy or the insurer says no, and what fixes it
Most first-fill delays are one of these. Knowing which one tells you who to call.
- 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.Cigna policy
- 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.FDA label
- 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.FDA label
- 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.Cigna policy
- 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.Cigna policy
- 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.Cigna policy
- 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.Co-Pay Program application
- 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.Co-Pay Program application
- 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.Cerdelga support page
Cigna prior authorization policy, July 15, 2026
- Gaucher disease type 1
- A CYP2D6 extensive, intermediate or poor metabolizer, as detected by an approved test
- The diagnosis is shown by low beta-glucocerebrosidase activity in white blood cells or skin cells, or by disease-causing variants in both GBA genes, with documentation
- Not used to manage neurological symptoms, such as abnormal eye movement, hearing loss, thinking problems or seizures
- Prescribed by, or with advice from, a geneticist, endocrinologist, metabolic disorder specialist or a doctor who specializes in Gaucher disease or related disorders
- Not used together with Cerezyme, Elelyso, Vpriv or Zavesca
Approval length. 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. Cigna policy
Who to call, and what they can do
The drugmaker's program handles most of the first-fill problems above. Charity funds and foundation help are on the help paying page.
- 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
Details as the drugmaker publishes them. CareConnect for HCPs
Five questions for the pharmacist or the support line
- Which of my medicines, vitamins or supplements interact with Cerdelga?
- Before I start a new prescription or over-the-counter medicine, who checks it against Cerdelga?
- How many capsules are in each shipment, and how many days will it last at my dose?
- When should I order my next refill so I do not run out?
- Which foods and drinks count as grapefruit products?
- Has my Co-Pay Program been applied to this fill?
Questions people ask in the first weeks
Why do I need a gene test before Cerdelga?
CYP2D6 is the main enzyme that breaks down Cerdelga, and people differ in how fast it works. The label says to select patients with an FDA-cleared CYP2D6 genotype test. The result sets whether you take 84mg once or twice a day.
Who cannot take Cerdelga because of the gene test?
The label says ultra-rapid metabolizers may not reach a drug level high enough to work. For people whose result is indeterminate, it says no specific dose can be recommended. Sanofi says more than 90% of adults tested are eligible.
What is the dose of Cerdelga?
The label sets 84mg twice a day for extensive and intermediate metabolizers, and 84mg once a day for poor metabolizers. With certain other medicines, it lowers the twice-daily dose to once a day.
Can I eat grapefruit on Cerdelga?
The Medication Guide says to avoid eating or drinking grapefruit products while taking Cerdelga. Grapefruit products can increase the amount of Cerdelga in your body.
Does Cerdelga affect the heart?
At much higher than normal blood levels, the label predicts changes in the heart's electrical timing on an ECG. This is why certain medicine combinations are ruled out. Tell your doctor about new palpitations, fainting or dizziness.
Does Cerdelga have a boxed warning or a REMS?
No boxed warning appears on the label, and the label names no REMS program. It does carry a Medication Guide, which the pharmacy gives you with the capsules.
Can children take Cerdelga?
Cerdelga is approved for adults only. The label says its safety and effectiveness in children have not been established.
How soon can I switch from infusions to Cerdelga?
The label says Cerdelga may be given 24 hours after the last dose of imiglucerase, velaglucerase alfa or taliglucerase alfa. Your doctor plans the timing with you.
How long does it take to start Cerdelga after it is prescribed?
There is no fixed number of days. The gene test, the medicine review, prior authorization and the first shipment each take their own time. A CareConnect Case Manager can help with the insurance steps.
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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, March 3, 2024.
- Support and Resources | Cerdelga® (eliglustat) Capsules, Sanofi, July 1, 2024.
- How to Get Started on Cerdelga, Cerdelga Patient Checklist (MAT-US-2204844-v1.0-07/2022), Sanofi, July 1, 2022.
- Cerdelga® Eligibility Testing | For US HCPs, Sanofi, July 1, 2025.
- CareConnect for Healthcare Professionals, Sanofi, November 1, 2024.
- CareConnect Personalized Support Services Co-Pay Program Application, Substrate Reduction Therapy (MAT-US-2506609-v1.0-06/2025), Sanofi, June 1, 2025.
- Gaucher Disease – Substrate Reduction Therapy – Cerdelga, Drug Coverage Policy IP0441, Cigna, July 15, 2026.
- NDA 205494/S-03 supplement approval letter, long-term extension results, renal and hepatic impairment dosage recommendations, PLLR format, FDA, August 29, 2018.
- NDA 205494 approval letter, Cerdelga (eliglustat) capsules, FDA, August 19, 2014.
This page explains what the FDA label, the drugmaker's support program and an insurer policy say. It is not medical advice and does not tell anyone to start, stop or change a medicine. Dosing, test timing and restarts after a gap are decisions for the prescribing geneticist. Found an error? Use the report link in the footer and it will be checked against the source.