Prescribing guide
Cerezyme (imiglucerase)Dosing, weight-based infusion volumes, hypersensitivity management and prior authorization criteria for Gaucher diseaseFor 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. Boxed warning: initiate in a healthcare setting with monitoring and CPR equipment. Prior authorization and a site of care before the first infusion.
Example PA threshold
Cigna example: documented deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts, or biallelic pathogenic GBA variants; not for neurological manifestations; specialist prescriber; up to 60 U/kg no more than 3 times a week; no concurrent Gaucher therapy.
Monitoring
Supervised infusion with anaphylaxis readiness at every dose; premedicate after prior hypersensitivity; consider periodic IgG antibody monitoring during the first year; disease tests at the physician's discretion.
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 Cerezyme, 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/cerezymeBefore 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 |
|---|---|---|
| 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 and site of care | For patients starting treatment, CareConnect assists with insurance verification and explains coverage; it also helps find treatment centers and home infusion resources for travel and moves. | CareConnect for HCPs |
| Ordering and delivery | Purchase through authorized distributors, specialty pharmacies or directly from Sanofi. Rare Disease Product Services, 1-800-745-4447 option 1 or CO@Sanofi.com, sends infusion and refill reminders and has after-hours on-call service. | CareConnect for HCPs |
| Calculate vials | 400 unit single-dose vials, one per carton (NDC 58468-4663-1), refrigerated at 2°C to 8°C, no preservatives. Number of vials set by the individual dosage regimen. | FDA label |
| Reconstitute | 10.2mL Sterile Water for Injection per vial, down the inside wall; roll and tilt, do not shake; yields 40 units/mL. Hold up to 12 hours refrigerated or at 20°C to 25°C if not used immediately. | FDA label |
| Dilute | 0.9% sodium chloride; at 60 units/kg use Table 1 volumes (12, 26, 100, 200 or 400mL by weight). Otherwise 6 to 30 units/mL; 26mL or less by syringe pump. Diluted solution up to 24 hours at 2°C to 8°C. | FDA label |
| Billing code | HCPCS J1786, injection, imiglucerase, 10 units, as listed in the Cigna policy. | Cigna policy |
| Co-Pay Program | Commercial only: 100% of eligible out-of-pocket drug costs up to a program maximum, plus certain infusion-related charges. 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 Medicaid, Medicare (including Part D), Medigap, VA, DoD, TRICARE and state programs. Infusion-related costs not covered for commercially insured patients in MA or RI. | 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. | CareConnect for HCPs |
Prior authorization criteria and what to document
One public policy as the example: Cigna, May 15, 2026. Approval 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.
| Element | What the policy asks | In the chart | Source |
|---|---|---|---|
| Diagnosis, enzyme route | Deficient beta-glucocerebrosidase activity in leukocytes or fibroblasts [documentation required] | Enzyme assay report | Cigna policy |
| Diagnosis, genetic route | Molecular genetic testing documenting biallelic pathogenic GBA variants [documentation required]; either route qualifies | Genetic test report | Cigna policy |
| Type | Type 1 (non-neuronopathic) or type 3 (chronic neuronopathic); no age criterion since May 2026 | Diagnosis in the note | Cigna policy |
| Use | Not for neurological manifestations (examples: abnormal ocular movement, auditory impairment, cognitive impairment, seizures) | Treatment goals in the note | Cigna policy |
| Prescriber | Geneticist, endocrinologist, metabolic disorder sub-specialist or lysosomal storage disorder specialist, or in consultation with one | Prescriber specialty or consult note | Cigna policy |
| Dosing | Each dose no more than 60 U/kg IV, no more often than 3 times a week | Order with current weight and frequency | Cigna policy |
| Concurrent therapy | Not medically necessary with Cerdelga, Elelyso, VPRIV or Zavesca | Current medication list | Cigna policy |
| Approval | 1 year | Updated criteria at each review | Cigna policy |
Cerezyme dosing and titration
| When | Label | Source |
|---|---|---|
| Dose | 2.5 units/kg three times a week to 60 units/kg once every 2 weeks IV; titrate to disease severity and therapeutic goals. | FDA label |
| Trial regimen | Study 1: 60 units/kg every other week for 6 months. | FDA label |
| Infusion time | Over 20kg: 1 to 2 hours. 20kg or less: 2 hours. Maximum rates 6, 13, 50, 200 and 400mL/hour across the Table 1 weight bands. | FDA label |
| Administration set | 0.2 micron in-line low protein-binding filter. | FDA label |
| Before infusion | After any prior hypersensitivity reaction to Cerezyme, premedicate with antihistamines and/or corticosteroids and monitor for new reactions. | FDA label |
| Mild or moderate reaction | Hypersensitivity or IAR: consider decreasing the rate, temporarily stopping, and/or antihistamines, antipyretics and/or corticosteroids. | FDA label |
| Severe reaction | Discontinue and initiate treatment immediately, including epinephrine for anaphylaxis. If readministering, consider a slower rate and antihistamines, antipyretics and/or corticosteroids. | FDA label |
| Pediatric | Indicated in pediatric patients with no lower age limit; Table 1 volumes start at 1.5kg. Study 3 registry ages: type 1, 19 weeks to 87 years; type 3, 7 weeks to 54 years. | FDA label |
| Missed dose, renal, hepatic | The label gives no missed-dose instruction and no renal or hepatic impairment section. | FDA label |
Monitoring the Cerezyme label requires
| When | What | What the label says to do with it | Source |
|---|---|---|---|
| Each infusion | Hypersensitivity, including anaphylaxis: pruritus, flushing, urticaria, angioedema, chest discomfort, dyspnea, cough, cyanosis, tachycardia, hypotension | Anaphylaxis can occur early or after extended therapy. If severe, discontinue and treat immediately, including epinephrine | FDA label |
| Each infusion | IARs: angioedema, pruritus, rash, urticaria, chest discomfort, chills, fatigue, infusion-site burning, discomfort or swelling, pyrexia, hypertension | Severe: discontinue and treat; weigh readministration. Mild or moderate: slow, pause or premedicate | FDA label |
| First year | IgG antibody to imiglucerase | Consider periodic monitoring. About 15% develop IgG in year 1, largely within 6 months, rarely after 12 months; about 46% of antibody-positive patients had hypersensitivity symptoms | FDA label |
| Ongoing | Spleen, liver, blood and bone assessments | Sanofi: the physician decides which tests and how often; the label sets no schedule | Cerezyme treatment page |
| Ongoing | Gaucher patient registry, including pregnancy and lactation | registrynxt.com or 1-800-745-4447, extension 15500; report adverse reactions to Genzyme at 1-800-633-1610 | FDA label |
Cerezyme drug interactions and contraindications
| Label category | Agents and what the label says | Source |
|---|---|---|
| Contraindications | None | FDA label |
| Drug interactions | The label has no drug interactions section | FDA label |
| Other Gaucher therapies | Concurrent use with Cerdelga, Elelyso, VPRIV or Zavesca not medically necessary under the Cigna policy; the Cerezyme label does not address it | Cigna policy |
| Pregnancy | More than 500 pregnancies (registry, postmarketing, observational studies, case reports): no drug-associated risk identified; pregnancy may exacerbate type 1 disease; no animal reproduction studies | FDA label |
| Lactation | Small amount in milk immediately after infusion; no adverse effects reported in breastfed infants; no data on milk production | FDA label |
| Geriatric | Study 3 type 1 cohort (n = 1,053): 6% 65 and over, 1% 75 and over; no overall differences in effectiveness | FDA label |
Why a first fill stalls, and the fix
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 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
Questions prescribers' offices ask about Cerezyme
What is the Cerezyme dose for Gaucher disease type 1 and type 3?
The August 2026 DailyMed label (FDA-approved text January 2026) gives 2.5 units/kg three times a week to 60 units/kg once every 2 weeks IV. Titrate to disease severity and therapeutic goals; therapy should be directed by physicians knowledgeable in Gaucher disease. Study 1 used 60 units/kg every other week.
How long is a Cerezyme infusion and what volume is used?
The August 2026 label sets 1 to 2 hours above 20kg and 2 hours at 20kg or less. At 60 units/kg the total volume is 12mL (1.5 to under 6kg), 26mL (6 to under 13kg), 100mL (13 to 20kg), 200mL (over 20 to 100kg) or 400mL (over 100kg). At lower doses, dilute to 6 to 30 units/mL; volumes of 26mL or less go by syringe pump.
Is premedication required before Cerezyme infusions?
Only for patients who have had hypersensitivity reactions to Cerezyme: premedicate with antihistamines and/or corticosteroids, per section 2.1 of the August 2026 label. For mild or moderate hypersensitivity or IARs, consider slowing or pausing the infusion and giving antihistamines, antipyretics and/or corticosteroids. For severe reactions, discontinue and treat immediately, including epinephrine.
Can Cerezyme be infused at home?
The label requires initiation in a healthcare setting with monitoring and CPR equipment and sets no number of infusions before a change of site, per the August 2026 label. Every administration should be supervised by a provider knowledgeable in managing anaphylaxis. Sanofi lists a doctor's office, a treatment center or, in some cases, home as infusion settings.
What are the Cerezyme prior authorization criteria?
The Cigna policy shown here, IP0162 effective May 15, 2026, approves 1 year for type 1 or type 3 with documented deficient beta-glucocerebrosidase activity or biallelic pathogenic GBA variants. It also requires no use for neurological manifestations, a specialist prescriber, and doses no more than 60 U/kg no more than 3 times a week. Concurrent Cerdelga, Elelyso, VPRIV or Zavesca is not covered.
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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, 2026-08-27.
- CEREZYME (imiglucerase) for injection, for intravenous use, prescribing information, revised 12/2024, FDA, Drugs@FDA, 2024-12-19.
- The Treatment Experience | Cerezyme® (imiglucerase), Sanofi, 2026-01.
- Support and Access | Cerezyme® (imiglucerase), Sanofi, 2026-01.
- Starting Your Journey With Cerezyme® (imiglucerase) for Injection, patient brochure (MAT-US-2015608-v8.0-01/2026), Sanofi, 2026-01.
- CareConnect for Healthcare Professionals, Sanofi, 2024-11.
- CareConnect Personalized Support Services Co-Pay Program Application, Enzyme Replacement Therapies (MAT-US-2506611-v1.0-06/2025), Sanofi, 2025-06.
- Gaucher Disease - Enzyme Replacement Therapy - Cerezyme, Drug Coverage Policy IP0162, Cigna, 2026-05-15.
- BLA 020367/S-123 supplement approval letter, Type 3 Gaucher disease and pediatric patients under 2 years, FDA, 2026-01-12.
- BLA 020367/S-122 supplement approval letter, hypertension added to warnings and adverse reactions, FDA, 2024-12-19.
- BLA 020367/S-121 supplement approval letter, enzyme replacement therapy class safety labeling change for hypersensitivity, FDA, 2024-07-10.
A reference drawn from the August 27, 2026 label, the drugmaker's published program and one public insurer policy shown as an example, checked on November 8, 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.