Your first 90 days
Your first 90 days on Lumizyme for Pompe 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.
Lumizyme is a long-term schedule of IV infusions every 2 weeks, at a dose worked out from body weight. The first 90 days hold 7 infusions, and this page lays out that stretch for patients, parents and caregivers. It draws on the FDA label, Sanofi's CareConnect program and one insurer's written rules.
What has to happen before the first bottle ships
Lumizyme has no REMS today, so the first infusion waits on a confirmed diagnosis, baseline blood tests, an insurance approval and a setting ready to treat a severe allergic reaction. These are the 7 things in the way, in order.
A confirmed diagnosis
The Cigna policy shown below asks for a lab test showing low acid alpha-glucosidase (GAA) enzyme activity, or a genetic test showing changes in both copies of the GAA gene.Cigna policy
A CRIM test for infants
For infantile-onset Pompe disease, the label says a CRIM test should be done early.
- CRIM-negative means no natural GAA enzyme is detected, which raises the chance of high antibody levels.FDA label
A specialist for infants
The label says infants with infantile-onset disease should be managed by a specialist who knows immune tolerance induction.
- In CRIM-negative infants, that treatment has been reported to reduce high antibody levels.FDA label
A baseline antibody blood sample
The label strongly encourages a blood sample before the first infusion.
- It gives the care team a starting point for later antibody tests.FDA label
Current weight
The dose is counted per kilogram of actual body weight.
- Weight also sets the size of the infusion bag, from 25mL for a small newborn to 1,000mL for a very large adult.FDA label
A healthcare setting ready for reactions
The label says to start Lumizyme in a healthcare setting with medical monitoring and equipment to restart breathing and the heart, because severe allergic reactions can happen.FDA label
Signing up with CareConnect, and the insurance check
Your doctor can send a link to a digital consent form, or you can call a Case Manager.
- Sanofi says the program is free, voluntary and confidential, and can verify insurance.CareConnect for HCPs
The days that matter
Counted from the first infusion, on the every 2 weeks schedule the label sets for everyone who takes Lumizyme. 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.
Baseline blood tests
The label strongly encourages an antibody blood sample before the first infusion.
- For infantile-onset disease, it also says a CRIM test should be done early.
First infusion
The infusion starts at no more than 1mg/kg per hour.
- If it is tolerated, staff raise the rate every 30 minutes and check vital signs at each step, and the infusion takes about 4 hours.
Infusion 2
Allergic reactions have been seen during an infusion and up to 3 hours after it.
- The label says people who have had an infusion reaction should be watched closely when Lumizyme is given again.
Infusion 3
If one or more infusions are missed, the label says to restart as soon as possible and keep 2 weeks between infusions after that.
Infusion 4
Lumizyme is ordered for each infusion, and vials come in cartons of 1 or 10.
- Sanofi's Product Services team can send infusion and refill reminders so each shipment arrives on time.
Infusion 5
In the late-onset trial, everyone tested formed antibodies to Lumizyme, most within the first 3 months.
- Some people with high, lasting antibody levels had a weaker response to treatment.
Infusion 6
The label calls for urine tests from time to time, because immune reactions can affect the kidneys.
- These reactions appeared several weeks to 3 years after starting.
Infusion 7
For infantile-onset disease, the label suggests regular antibody tests in the first year, for example every 3 months.
- For late-onset disease, it suggests a test within six months.
The label, revision by revision
The FDA lists which sections changed in each revision of a label. These are the revisions the current Lumizyme 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 January 10, 2025, read from the FDA's label database today. FDA label
- January 2025
DailyMed posted version 21 of the label, and its change list dates updates to the boxed warning, dosing and warnings to March and December 2024.FDA label
- December 2024
The FDA approved an update to how the label presents antibody information, in line with FDA guidance on that topic.FDA letter
- March 2024
The FDA added a warning for infusion reactions, and fainting, low blood pressure and a slow heartbeat were added as reactions linked to Lumizyme.FDA letter
- May 2023
The label now says allergic reactions in the infant and juvenile trials were more likely at higher doses, as well as at faster infusion speeds.FDA letter
- August 2014
The FDA extended Lumizyme to all patients with Pompe disease, including infantile-onset disease and children under 8, and ended the Lumizyme REMS.FDA letter
- May 2010
The FDA approved Lumizyme for people 8 and older with late-onset Pompe disease and no enlarged heart, under a REMS that restricted who could prescribe and dispense it.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 set by weight
The recommended dose is 20mg/kg of body weight every 2 weeks, by IV infusion.
- It is the same per kilogram for infants, children and adults.FDA label
- How the dose is mixed
Each vial holds 50mg of powder, mixed with sterile water and then added to a salt water (saline) bag.
- The number of vials is rounded up to the next whole vial.FDA label
- How many vials
Sanofi gives the example of a person who weighs 68kg (about 150 lb).
- That dose is 1,360mg, which rounds up to 28 vials for each infusion.Lumizyme dosing page (HCP)
- Infusion size goes with weight
The bag holds 25mL for a newborn of 1.25 to 2.5kg (about 2.8 to 5.5 lb).
- It holds 500mL for a person of 60.1 to 100kg (about 133 to 220 lb).FDA label
- Infusion speed
Every infusion starts at no more than 1mg/kg per hour.
- Once tolerated, it may go up by 2mg/kg per hour every 30 minutes, to a top rate of 7mg/kg per hour.FDA label
- Medicines before an infusion
The label tells doctors to consider allergy, fever or steroid medicines before an infusion.
- In studies, some people who got these medicines still had allergic reactions.FDA label
- If a mild or moderate reaction happens
Staff may slow the infusion or stop it for a while.
- They may also give allergy or fever medicines to ease the symptoms.FDA label
- If a severe reaction happens
The label says to stop Lumizyme and start medical treatment right away, including epinephrine.
- Your doctor then weighs whether to try again, possibly at a lower dose and slower speed.FDA label
- Antibody blood tests
The label says antibody levels should be checked during treatment.
- It suggests regular tests in the first year for infantile-onset disease, and a test within six months for late-onset disease.FDA label
- Urine tests
The label says people on Lumizyme should be checked for immune reactions in the skin and other organs, including a urine test from time to time.FDA label
- Anesthesia for a central line
Some infants with an enlarged heart had dangerous heart rhythms, cardiac arrest or death under general anesthesia for central line placement, so the label tells doctors to use caution.FDA label
- If an infusion is missed
The label says to restart as soon as possible, then keep a 2 week gap between infusions after that.FDA label
- Pregnancy
Reports so far have not shown a risk of birth defects or miscarriage from Lumizyme.
- Untreated Pompe disease may worsen in pregnancy, so the label says the choice should fit each woman.FDA label
- Breastfeeding
Published reports suggest Lumizyme passes into breast milk, the label says.
- It adds that a mother may consider pumping and discarding milk during treatment and for 24 hours after an infusion.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
Sanofi lists trouble breathing or shallow breathing, an abnormal heart rate, low blood pressure, throat tightness, swelling of the tongue, lip or face, and rash or hives.
- The label says to seek immediate medical care if these symptoms occur.Lumizyme patient site
When allergic reactions happen
The label says allergic reactions have been seen during an infusion and up to 3 hours after it.
- Anaphylaxis has happened early in treatment and after a long time on it.FDA label
Signs of an immune reaction
Sanofi lists kidney problems, including high protein levels in the urine, and severe skin sores with tissue death.
- The label says to seek medical care right away for these symptoms.Lumizyme patient site
Heart or lung strain from the fluid
Infants with infantile-onset disease and weak heart or lung function may suddenly get worse from the infusion fluid.
- The label says they need extra monitoring, and some need longer observation.FDA label
Infusion reactions
The label lists fever, chills, flu-like illness, muscle or joint pain, tiredness, hives, rash, itching, shortness of breath, fast heartbeat, flushing, nausea, headache and fainting.FDA label
Reactions in the days after
In the late-onset trial, some reactions came 2 to 48 hours after the infusion ended, including heavy sweating, tiredness, muscle pain and nausea.FDA label
How common reactions were
In the infant trials, 20 of 39 children (51%) had allergic-type reactions that needed care.
- The most common were rash (18%), fever (15%), hives (13%) and flushing (13%).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 GAA enzyme activity in blood, skin cells or muscle, or a genetic test showing changes in both GAA genes.Cigna policy
- The doctor is not a specialistCigna asks that Lumizyme be prescribed by, or with advice from, a geneticist, neurologist, metabolic specialist or lysosomal storage disorder specialist.Cigna policy
- A dose outside the plan's limitCigna approves doses up to 20mg/kg by IV, no more often than once every 2 weeks, and other doses are reviewed case by case.Cigna policy
- The plan covers a different Pompe medicineSanofi tells doctors to confirm Lumizyme coverage with the plan before an infusion in late-onset disease, because more than one enzyme replacement therapy exists.Lumizyme billing guide
- The plan limits where infusions happenSanofi says some plans have site of care rules or contracts with certain providers. Your doctor's office or a CareConnect Case Manager can check before the first infusion.Lumizyme billing guide
- A copay you cannot payCommercial insurance: the 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 Lumizyme at no cost. Sanofi calls it a temporary solution until coverage can be secured, and Case Managers are at 1-800-745-4447, option 3.CareConnect for HCPs
Cigna prior authorization policy, August 15, 2026
- Acid alpha-glucosidase deficiency (Pompe disease), with no age limit in the policy
- Diagnosis shown by low acid alpha-glucosidase activity in blood, skin cells or muscle, with documents
- Or diagnosis shown by disease-causing variants in both GAA genes on a genetic test, with documents
- Prescribed by, or with advice from, a geneticist, neurologist, metabolic disorder specialist or lysosomal storage disorder specialist
- Each dose no more than 20mg/kg by IV, no more often than once every 2 weeks
Approval length. One year.
This policy (Drug Coverage Policy IP0440) added documentation requirements on August 15, 2026. It cites the December 2024 label, which is the current FDA-approved text. 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, with Spanish at option 7
- A Patient Education Liaison for disease, treatment and inheritance education. Families and caregivers may take part too
- Patient Education Liaisons have a clinical background in nursing or genetic counseling, and Case Managers can explore options if you have no insurance CareConnect services page
- The 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
- The 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 the Lumizyme for each infusion, and where is it shipped?
- Is the dose based on current weight, and who do I tell when my child's weight changes?
- How many vials make up the dose, and how long will the infusion run?
- Which medicines will be given before the infusion, and why?
- When are the antibody blood tests and urine tests due, and who orders them?
- Has the Co-Pay Program been applied, and does it cover the infusion charges where I live?
Questions people ask in the first weeks
How long does a Lumizyme infusion take?
The label says about 4 hours, because the rate starts at no more than 1mg/kg per hour and steps up every 30 minutes, to a top of 7mg/kg per hour.
How is the dose worked out?
The dose is set by weight, at a recommended 20mg/kg every 2 weeks at every age. Vials hold 50mg each, and the number of vials is rounded up to the next whole vial.
Can babies receive Lumizyme?
Yes, since August 2014 the label has covered all patients with Pompe disease, including infantile-onset disease. Infant trials enrolled babies as young as 0.2 months at the first infusion.
What is CRIM status, and why does it matter?
CRIM-negative means no natural GAA enzyme is detected, the label explains. It says CRIM-negative infants with high, lasting antibody levels responded less well, so it asks for an early CRIM test.
Does Lumizyme have a boxed warning?
Yes, Lumizyme has a boxed warning, the strongest kind the FDA requires. It covers severe allergic reactions including anaphylaxis, immune reactions that can affect the kidneys and skin, and sudden heart or lung failure in infants with weak heart or lung function.
Can Lumizyme be given at home?
The label says to start Lumizyme in a healthcare setting. Sanofi's billing guide lists the home as one setting, if the prescribing doctor finds it clinically appropriate.
What if an infusion is missed?
The label says to restart as soon as possible, then keep 2 weeks between infusions after that.
How long does it take to start Lumizyme after it is prescribed?
No source gives a fixed number of days, because the diagnosis paperwork, baseline tests, prior authorization and booking each take their own time. A CareConnect Case Manager can help with the insurance steps.
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Sources
- LUMIZYME (alglucosidase alfa), for injection, for intravenous use, prescribing information, Revised 12/2024 (DailyMed version 21, updated January 10, 2025), Genzyme Corporation, via DailyMed and openFDA, January 10, 2025.
- Lumizyme | Patients & Families, Sanofi, March 1, 2025.
- Lumizyme® Dosing and Administration | For US HCPs, Sanofi, September 1, 2025.
- Lumizyme® (alglucosidase alfa) Billing and Coding Guide for Reimbursement (MAT-US-2002147-v5.0-06/2026), Sanofi, June 1, 2026.
- CareConnect for Healthcare Professionals, Sanofi, November 1, 2024.
- Our Services and Team | Sanofi CareConnect, Sanofi, November 1, 2025.
- CareConnect Personalized Support Services Co-Pay Program Application, Enzyme Replacement Therapies (MAT-US-2506611-v1.0-06/2025), Sanofi, June 1, 2025.
- Pompe Disease – Enzyme Replacement Therapy – Lumizyme, Drug Coverage Policy IP0440, Cigna, August 15, 2026.
- BLA 125291/S-161 supplement approval letter, Lumizyme (alglucosidase alfa), immunogenicity labeling update, FDA, December 30, 2024.
- BLA 125291/S-160 supplement approval letter, Lumizyme (alglucosidase alfa), new warning for infusion-associated reactions, FDA, March 22, 2024.
- BLA 125291/S-159 supplement approval letter, Lumizyme (alglucosidase alfa), adverse reactions update, FDA, May 24, 2023.
- BLA 125291/136 supplement approval and release of REMS requirement letter, Lumizyme (alglucosidase alfa), FDA, August 1, 2014.
- BL 125291/0 BLA approval letter, Lumizyme (alglucosidase alfa), FDA, May 24, 2010.
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 neurologist. Found an error? Use the report link in the footer and it will be checked against the source.