Your first 90 days
Your first 90 days on Cerezyme 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.
Cerezyme is a long-term schedule of IV infusions, with a dose your doctor sets from your weight and how severe the disease is. Unlike many drugs, the label gives a range of doses and schedules instead of one fixed plan. If your doctor picks the every 2 weeks schedule used in the main trial, the first 90 days hold 7 infusions. This page lays out that stretch from the FDA label, Sanofi's CareConnect program and one insurer's written rules.
What has to happen before the first bottle ships
Cerezyme has no REMS, so the first infusion waits on a confirmed diagnosis, a dose plan, an insurance approval and a healthcare setting ready for allergic reactions. These are the 6 things in the way, in order.
A confirmed diagnosis
The Cigna policy shown below asks for a blood or skin cell test showing low enzyme activity, or a genetic test showing changes in both copies of the GBA gene.Cigna policy
A dose plan from your doctor
The label says a doctor who knows Gaucher disease should direct treatment.
- Your doctor sets the dose and how often you get it, based on disease severity and treatment goals.FDA label
Your current weight
The dose is counted in units per kilogram, so your weight sets how many vials are mixed.
- Weight also sets the size of the infusion bag or syringe and how long it runs.FDA label
Where the first infusion will happen
The label asks that Cerezyme be started in a healthcare setting with equipment to restart breathing and the heart.
- Sanofi lists a doctor's office, a treatment center or, in some cases, home.Cerezyme treatment page
Signing up with CareConnect
Your doctor can send you a link to a digital consent form, or you can call a Case Manager.
- Sanofi says the program is free, voluntary and confidential.CareConnect for HCPs
The insurance check
For someone just starting treatment, Sanofi says CareConnect can help verify insurance and explain your coverage.
- A Case Manager can also help later if your insurance changes.CareConnect for HCPs
The days that matter
Counted from the first infusion, using the every 2 weeks schedule from the main trial. Your doctor may choose another schedule in the label's range, up to 3 times a week. 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.Enrollment and the insurance check
You enroll in CareConnect, and a Case Manager helps check your insurance.
- No source sets how long this takes, because each insurer works on its own timeline.
Approval, then booking the first infusion
Once the plan approves, the first infusion can be booked in a healthcare setting that is ready to treat a severe allergic reaction, as the label requires.
First infusion
A healthcare provider who knows how to treat anaphylaxis supervises the infusion.
- It runs 1 to 2 hours for people over 20kg (about 44 lb), and 2 hours for smaller children.
Infusion 2, on an every 2 weeks schedule
If you had an allergic reaction to Cerezyme before, the label says to give allergy medicines or steroids beforehand.
- The label also lets your doctor adjust the dose over time, based on severity and treatment goals.
Infusion 3
Sanofi says the doctor decides which tests you need and how often.
- These may include checks of the spleen and liver, the blood and the bones.
Infusion 4
Clinics buy Cerezyme through distributors, specialty pharmacies or Sanofi directly.
- Sanofi's Product Services team can send infusion and refill reminders so each shipment arrives on time.
Infusion 5
Sanofi says infusions can happen at a doctor's office, a treatment center or, in some cases, at home.
- Ask your doctor which setting fits you or your child.
Infusion 6
About 15% of patients form antibodies to Cerezyme in the first year, mostly within 6 months.
- The label suggests doctors consider checking for them during that first year.
Infusion 7
This is the seventh infusion counted from day 1.
- In the main trial, blood counts and spleen and liver size were measured at 6 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 Cerezyme 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 August 27, 2026, read from the FDA's label database today. FDA label
- August 2026
DailyMed posted version 28 of the label. Its recent changes list still dates the last major changes to January 2026.FDA label
- January 2026
The FDA added type 3 Gaucher disease and extended type 1 use to children under 2. The label now gives infusion volumes by weight down to 1.5kg (about 3.3 lb), and requires a filter in the IV line.FDA letter
- December 2024
High blood pressure was added to the warnings and side effects as a possible reaction during infusions.FDA letter
- July 2024
The FDA added a boxed warning for severe allergic reactions, including anaphylaxis, as part of a change for enzyme replacement therapies as a group. Cerezyme must now be started in a healthcare setting with emergency equipment.FDA 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.
- A dose made for you
The label gives a range from 2.5 units/kg three times a week to 60 units/kg once every 2 weeks.
- Your doctor adjusts it to disease severity and treatment goals.FDA label
- How the dose is mixed
Each vial holds 400 units of powder, mixed with sterile water and then added to salt water.
- The number of vials depends on your dose and weight.FDA label
- Infusion size goes with weight
At 60 units/kg, the label sets 200mL for people over 20kg (about 44 lb) up to 100kg (about 220 lb), and 400mL above that.
- Children 20kg (about 44 lb) or less get 12mL to 100mL.FDA label
- Infusion time
Infusions run 1 to 2 hours for people over 20kg (about 44 lb), and 2 hours for children 20kg or less.
- A filter in the IV line is required.FDA label
- Medicines before an infusion
The label calls for antihistamines or steroids before infusions in people who have had an allergic reaction to Cerezyme.
- Your doctor decides what you or your child gets.FDA label
- If a reaction happens
For a mild or moderate reaction, staff may slow or pause the infusion or give allergy, fever or steroid medicines.
- For a severe one, the label says to stop Cerezyme and treat at once.FDA label
- If an infusion is missed
The label gives no missed-dose instructions.
- Sanofi says to talk to your doctor right away about rescheduling, and to plan ahead for travel or a move.Cerezyme treatment page
- Pregnancy
Data on more than 500 pregnancies have not shown a drug-related risk of birth defects or miscarriage.
- Pregnancy can make Gaucher disease worse, and the label invites you to join a registry at 1-800-745-4447, extension 15500.FDA label
- Breastfeeding
A small amount of Cerezyme may reach breast milk right after an infusion.
- Reports in breastfed babies have not shown harmful effects, and you and your doctor weigh the choices together.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.
Signs of a severe allergic reaction
Itching, flushing, hives, swelling under the skin, chest discomfort, shortness of breath, cough, bluish skin, a fast heartbeat or low blood pressure.
- The label says to get medical care right away.FDA label
Anaphylaxis can come late in treatment
The boxed warning says anaphylaxis has happened early in treatment and after long use.
- If it happens, the label says to stop Cerezyme and treat it at once, including with epinephrine.FDA label
Infusion reactions
Rash, chills, tiredness, fever, high blood pressure, or burning, discomfort or swelling where the IV goes in.
- Tell your infusion team, who may slow or stop the infusion.FDA label
Antibodies and allergy
About 46% of people who formed antibodies to Cerezyme had allergy symptoms.
- Some people with allergy symptoms have no antibodies that a test can find.FDA label
Other side effects
The label lists back pain, chills, dizziness, tiredness, headache, nausea, fever and vomiting in adults and children.
- It gives no percentages, because some reports came in voluntarily after approval.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 a lab report showing low enzyme activity in white blood cells or skin cells, or a genetic test showing changes in both GBA genes.Cigna policy
- The doctor is not a specialistCigna asks that Cerezyme be prescribed by, or with advice from, a geneticist, endocrinologist, metabolic specialist or lysosomal storage disorder specialist.Cigna policy
- The request mentions brain or nerve symptomsCigna does not cover Cerezyme for neurological symptoms such as seizures or eye movement problems. The label also covers only the body symptoms of Gaucher disease.Cigna policy
- Also taking another Gaucher medicineCigna treats Cerezyme used together with Cerdelga, Elelyso, VPRIV or Zavesca as not medically necessary. Your doctor decides which treatment fits you.Cigna policy
- A dose above the plan's limitCigna allows up to 60 units/kg per dose, no more often than 3 times a week. Other doses go outside the written criteria.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
- You live in Massachusetts or Rhode IslandUnder state law, the Co-Pay Program does not cover infusion-related costs for commercially insured residents of these 2 states.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.CareConnect for HCPs
Cigna prior authorization policy, May 15, 2026
- Gaucher disease type 1 or type 3, confirmed by one documented test
- The test shows low beta-glucocerebrosidase activity in white blood cells or skin cells, or disease-causing variants in both GBA genes
- 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 lysosomal storage disorder specialist
- Each dose no more than 60 units/kg by IV, no more often than 3 times a week
- Not used together with Cerdelga, Elelyso, VPRIV or Zavesca
Approval length. One year.
This policy (Drug Coverage Policy IP0162) added type 3 to its main criteria and dropped its age limit on May 1, 2026, after the January 2026 label change. Its reference list cites a January 2025 label, but the FDA approved the type 3 use in January 2026. 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 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 clinical background, for disease, treatment and inheritance education
- The CareConnect Co-Pay Program for commercial insurance, covering eligible drug costs and certain infusion-related charges up to a program maximum, with questions answered at 1-855-448-6520
- Co-pay help is not open to Medicare, Medicaid, VA, Department of Defense or TRICARE patients, under the program's terms
- The CareConnect Patient Assistance Program, certain Sanofi therapies at no cost for eligible people without insurance or whose plan will not cover them
- Help finding treatment centers and home infusion resources when you travel or move
Details as the drugmaker publishes them. CareConnect for HCPs
Five questions for the pharmacist or the support line
- Who orders my Cerezyme for each infusion, and where is it shipped?
- Is my dose based on my current weight, and who do I tell if my weight or my child's weight changes?
- How many vials make up my dose, and how long will my infusion run?
- Will I get any medicine before my infusion, and why or why not?
- If I move to home infusion, who brings the medicine and who watches me during the infusion?
- Has my Co-Pay Program been applied to both the medicine and the infusion costs?
Questions people ask in the first weeks
How long does a Cerezyme infusion take?
The label sets 1 to 2 hours for adults and children over 20kg (about 44 lb). For children 20kg or less, each infusion runs over 2 hours. The total volume and top speed depend on weight.
How often will I get Cerezyme?
Your doctor decides. The label allows anything from 2.5 units/kg three times a week to 60 units/kg once every 2 weeks. The main trial used 60 units/kg every other week.
Can I get Cerezyme at home?
Not at first. The label says to start Cerezyme in a healthcare setting with emergency equipment. Sanofi says infusions can later happen at a doctor's office, a treatment center or, in some cases, at home.
Will I get medicine before my infusion?
Only if needed, according to the label. It calls for antihistamines or steroids before infusions in people who have had an allergic reaction to Cerezyme. Your doctor decides what you get.
Does Cerezyme have a boxed warning?
Yes. Since July 2024 the label has carried a boxed warning for severe allergic reactions, including anaphylaxis. The FDA asked for this warning on enzyme replacement therapies as a group.
Can babies and young children receive Cerezyme?
Yes. Since January 2026 the label covers adults and children with no lower age limit. It gives infusion volumes for babies as small as 1.5kg (about 3.3 lb).
Does Cerezyme treat type 3 brain symptoms?
No. The label covers only the body symptoms of type 1 or type 3, such as an enlarged spleen or liver and low blood counts. Sanofi says no FDA-approved treatment exists for neurologic symptoms of Gaucher disease.
How long does it take to start Cerezyme after it is prescribed?
There is no fixed number of days. The diagnosis paperwork, the insurance check, prior authorization and booking an infusion site each take their own time. A CareConnect Case Manager can help with the insurance steps.
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Sources
- DailyMed - CEREZYME- imiglucerase injection, powder, lyophilized, for solution (updated August 27, 2026, SPL version 28, prescribing information revised 1/2026), Genzyme Corporation, via DailyMed, August 27, 2026.
- CEREZYME (imiglucerase) for injection, for intravenous use, prescribing information, revised 12/2024, FDA, Drugs@FDA, December 19, 2024.
- The Treatment Experience | Cerezyme® (imiglucerase), Sanofi, January 1, 2026.
- Support and Access | Cerezyme® (imiglucerase), Sanofi, January 1, 2026.
- Starting Your Journey With Cerezyme® (imiglucerase) for Injection, patient brochure (MAT-US-2015608-v8.0-01/2026), Sanofi, January 1, 2026.
- CareConnect for Healthcare Professionals, Sanofi, November 1, 2024.
- CareConnect Personalized Support Services Co-Pay Program Application, Enzyme Replacement Therapies (MAT-US-2506611-v1.0-06/2025), Sanofi, June 1, 2025.
- Gaucher Disease - Enzyme Replacement Therapy - Cerezyme, Drug Coverage Policy IP0162, Cigna, May 15, 2026.
- BLA 020367/S-123 supplement approval letter, Type 3 Gaucher disease and pediatric patients under 2 years, FDA, January 12, 2026.
- BLA 020367/S-122 supplement approval letter, hypertension added to warnings and adverse reactions, FDA, December 19, 2024.
- BLA 020367/S-121 supplement approval letter, enzyme replacement therapy class safety labeling change for hypersensitivity, FDA, July 10, 2024.
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.