Your first 90 days
Your first 90 days on Fabrazyme for Fabry 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.
Fabrazyme is a steady schedule of IV infusions every 2 weeks, with the same weight-based dose each time. The first visits are the slowest, because the label starts every patient at a low infusion rate. The first 90 days hold 7 infusions if none is moved. This page lays out that stretch from the FDA label, Sanofi's CareConnectPSS program and one insurer's written rules.
What has to happen before the first bottle ships
Fabrazyme has no REMS, so the first infusion waits on a confirmed diagnosis, 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 label covers people with confirmed Fabry disease.
- The Cigna policy shown below asks for an enzyme blood test or a genetic test showing a change in the GLA gene.Cigna policy
Where the first infusion will happen
Sanofi says your first infusion will be in a doctor's office, hospital or infusion center.
- The label asks that Fabrazyme be started in a healthcare setting with equipment to restart breathing and the heart.Starting Fabrazyme
Your heart history
Sanofi asks you to tell the infusion team about any known heart problems.
- The label says people with advanced Fabry disease and weaker heart function may face more serious infusion reactions.Starting Fabrazyme
Signing up with CareConnectPSS
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
A ride on infusion day
Sanofi suggests arranging transportation to and from the infusion site, especially for the first visit.
- It also says you may be able to request a set day or time.Starting Fabrazyme
The days that matter
Counted from the first infusion, with each infusion 2 weeks apart and the slow starting rate that can rise at later visits. 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 CareConnectPSS, 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 at a doctor's office, hospital or infusion center.
- Sanofi suggests arranging a ride for that first visit.
First infusion, at the slowest rate
The label starts Fabrazyme at 0.25mg a minute, in a healthcare setting with emergency equipment ready.
- In the main adult trial, these early infusions lasted about 280 minutes on average.
Infusion 2
For people weighing 30kg (about 66 lb) or more, the label lets the rate rise a little at each visit if there were no reactions.
- The shortest infusion it allows is 1.5 hours.
Infusion 3
The label says infusion reactions tended to become less frequent with continued treatment.
- They can still happen, even after medicines given beforehand and after long use.
Infusion 4
Clinics buy Fabrazyme through distributors, specialty pharmacies or Sanofi directly.
- Sanofi's Product Services team can send infusion and refill reminders ahead of time so each shipment arrives on time.
Infusion 5
Sanofi says that after several infusions, your doctor may offer infusions at home.
- Talk with your doctor about which setting is right for you.
Infusion 6
Most people who formed antibodies to Fabrazyme in trials did so within the first 3 months.
- People with antibodies had infusion reactions more often.
Infusion 7
This is the seventh infusion counted from day 1.
- The main adult trial measured kidney GL-3, the fatty substance Fabrazyme clears, at week 20, 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 Fabrazyme 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 22, 2025, read from the FDA's label database today. FDA label
- August 2025
DailyMed posted a new version with small wording changes and a product listing update. No dose, warning or use changed. Its recent changes list shows the month as XX/2024, an apparent placeholder.FDA label
- 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. Fabrazyme must now be started in a healthcare setting with emergency equipment.FDA letter
- February 2024
The warnings gained advice to consider antihistamines, fever reducers or steroids before infusions. The pregnancy and breastfeeding sections were rewritten using information Genzyme collected after approval.FDA letter
- March 2021
The FDA gave Fabrazyme traditional approval for adults and children 2 and older with confirmed Fabry disease. The original 2003 approval had been an accelerated approval.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.
- One dose every 2 weeks
The label gives 1mg/kg of body weight as an IV infusion every 2 weeks.
- A healthcare provider who knows how to treat severe allergic reactions should supervise it.FDA label
- How the dose is set
The number of 35mg and 5mg vials is worked out from your actual body weight.
- Each vial is mixed with sterile water, then added to a bag of salt water.FDA label
- Bag size goes with weight
The label sets a 50mL bag at 35kg (about 77 lb) or less, and 100mL up to 70kg (about 154 lb).
- Larger bags of 250mL and 500mL are used above 70kg and above 100kg (about 220 lb).FDA label
- A slow start
The first infusion runs at 0.25mg a minute (15mg an hour).
- For people under 30kg (about 66 lb), the rate never goes higher than that.FDA label
- Medicines before each infusion
Sanofi says you may be given a fever reducer, such as acetaminophen or ibuprofen, and an antihistamine before your infusion.
- Reactions can still happen after these medicines.
- Your doctor decides what you get.Starting Fabrazyme
- Watching for reactions
The label asks for emergency equipment to be ready during infusions.
- If a mild or moderate reaction happens, the label lets staff pause the infusion, slow it or lower the dose.FDA label
- If an infusion is missed
The label gives no missed-dose instructions.
- Sanofi says it is important to follow the infusion schedule your doctor prescribes.
- Ask your doctor's office what to do if you cannot make an infusion.Starting Fabrazyme
- Pregnancy
Data from the Fabry Registry, case reports and case series have not shown a drug-related risk of birth defects or miscarriage.
- The label asks you to report exposure at 1-800-633-1610, option 1.FDA label
- Breastfeeding
Small amounts of Fabrazyme have been found in breast milk.
- The label says there is not enough information on effects on the baby, so you and your provider 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
Swelling of the face, mouth or throat, wheezing, trouble breathing or swallowing, low blood pressure, hives, rash, flushing, chest discomfort, itching or a stuffy nose.
- The label says to get medical care right away.
- About 1% of patients had anaphylaxis or a severe reaction.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 Fabrazyme and treat it at once, including with epinephrine.FDA label
Infusion reactions
Chills, fever, feeling hot or cold, nausea, vomiting, headache, tingling, dizziness, flushing or a fast heartbeat, on the day of an infusion.
- In trials, 59% on Fabrazyme had these against 27% on placebo.
- Tell your infusion team.FDA label
Heart symptoms
Heart failure, heart attack, cardiac arrest and palpitations have been reported since approval.
- The label says people with advanced Fabry disease and weaker heart function face a higher risk from infusion reactions, and asks for close watching.FDA label
Common side effects
Nose, sinus and throat infections (53% against 42% on placebo), chills (49% against 13%), fever and headache (39% each), cough, tingling, tiredness, leg swelling, dizziness and rash.
- The label lists these as the most common.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, or a genetic test showing a disease-causing GLA variant. The genetics clinic's records usually answer what the plan is asking for.Cigna policy
- The prescriber is not a specialistCigna asks that Fabrazyme be prescribed by, or with advice from, a geneticist, endocrinologist, metabolic specialist or lysosomal storage disorder specialist. Prescribing in consultation with one of these specialists also counts.Cigna policy
- Also taking Galafold or ElfabrioCigna treats Fabrazyme given at the same time as Galafold (migalastat) or Elfabrio (pegunigalsidase alfa) as not medically necessary. Your geneticist 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. Our help paying page lists charity funds that may cover what remains.Co-Pay Program application
- Costs the Co-Pay Program does not coverSanofi lists office visits, nursing observation time, blood work, other tests, medicines given before the infusion and transportation as not covered. Ask your Case Manager about other help.Fabrazyme support page
- 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. The clinic's infusion charges may then fall on you.Fabrazyme support page
- 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 Fabrazyme 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, September 15, 2026
- Fabry disease shown by a lab test with low alpha-galactosidase A activity in white blood cells or skin cells, or by a genetic test with a disease-causing GLA variant (one of these, with documentation)
- Prescribed by, or with advice from, a geneticist, endocrinologist, metabolic disorder specialist or lysosomal storage disorder specialist
- No more than 1mg/kg, given by IV no more often than every 2 weeks
- Not given at the same time as Galafold (migalastat) or Elfabrio (pegunigalsidase alfa)
Approval length. One year, with extended approvals while the patient keeps meeting the criteria and dosing.
This policy (Drug Coverage Policy IP0406) cites the July 2024 label, which added the boxed warning. The current DailyMed version from August 2025 changed only wording, so nothing in the policy conflicts with it. The September 2026 update made documentation required for the diagnosis tests. The Blue Cross Blue Shield Federal Employee Program asks only for age 2 or older and Fabry disease, and approves 2 years at a time. 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 nursing or genetic counseling background, for disease, treatment and inheritance education
- The CareConnect Co-Pay Program for commercial insurance, covering eligible drug costs and certain infusion costs 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, Fabrazyme at no cost for eligible people without insurance or whose plan will not cover it
- Help finding an infusion center, home infusion support and planning infusions around travel, according to Sanofi's program brochure
Details as the drugmaker publishes them. CareConnectPSS
Five questions for the pharmacist or the support line
- Who orders my Fabrazyme for each infusion, and where is it shipped?
- Is my dose based on my current weight, and who do I tell if my weight changes?
- Which medicines will I get before each infusion, and should I take anything at home first?
- How fast will my infusion run today, and can it be sped up at later visits?
- 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 Fabrazyme infusion take?
Early infusions are the longest, because the label starts everyone at 0.25mg a minute. In the main adult trial, those infusions averaged about 280 to 300 minutes. For people 30kg (about 66 lb) or heavier, the rate can rise at later visits if there are no reactions, down to a minimum of 1.5 hours.
Can I get Fabrazyme at home?
Not at first. Sanofi says the first infusion happens in a doctor's office, hospital or infusion center. After several infusions, your doctor may give you the option of home infusion, and CareConnectPSS offers home infusion support.
Will I get medicine before my infusion?
Possibly. The label asks doctors to consider antihistamines, fever reducers or steroids before Fabrazyme to lower the chance of reactions. Sanofi says reactions can still happen after these medicines. Your doctor decides what you get.
Does Fabrazyme 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. It says anaphylaxis can happen early in treatment or after long use.
Do I need blood tests on Fabrazyme?
The label sets no scheduled blood test. After a severe allergic reaction, it asks doctors to consider testing for IgE antibodies. No commercial test exists, so the label tells doctors to contact Genzyme at 1-800-745-4447.
Can children receive Fabrazyme?
Yes, the label covers children 2 and older with confirmed Fabry disease. Its pediatric data come from a study of 16 children aged 8 to 16 and data on 24 children aged 2 to 7.
Can Fabrazyme be used with Galafold?
The Fabrazyme label does not discuss Galafold. The Cigna policy shown here treats using them at the same time as not medically necessary, and says the same for Elfabrio. Your geneticist decides which treatment fits you.
How long does it take to start Fabrazyme 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 CareConnectPSS Case Manager can help with the insurance steps.
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Sources
- FABRAZYME (agalsidase beta) for injection, for intravenous use, prescribing information (DailyMed SPL version 35), Genzyme Corporation, via DailyMed, August 22, 2025.
- FABRAZYME (agalsidase beta) for injection, for intravenous use, prescribing information, revised 7/2024, FDA, Drugs@FDA, July 10, 2024.
- What Is Fabrazyme® (agalsidase beta) for Fabry Disease?, Sanofi, July 1, 2024.
- Fabry Disease Resources & Support | Fabrazyme® (agalsidase beta), Sanofi, July 1, 2024.
- Home | Sanofi CareConnect, Sanofi, November 1, 2024.
- Our Services and Team | Sanofi CareConnect, Sanofi, November 1, 2025.
- For Healthcare Professionals, Sanofi, November 1, 2024.
- Connected Care Throughout the Journey, CareConnect Personalized Support Services (MAT-US-2511683-v1.0-10/2025), Sanofi, October 1, 2025.
- CareConnect Personalized Support Services Co-Pay Program Application, Enzyme Replacement Therapies (MAT-US-2506611-v1.0-06/2025), Sanofi, June 1, 2025.
- Enzyme Replacement Therapy – Fabrazyme, Drug Coverage Policy IP0406, Cigna, September 15, 2026.
- Pharmacy Policy 5.30.035, Fabrazyme, Blue Cross Blue Shield Federal Employee Program, April 1, 2026.
- BLA 103979/S-5313 supplement approval letter, boxed warning for hypersensitivity reactions, FDA, July 10, 2024.
- BLA 103979/S-5312 supplement approval letter, hypersensitivity and specific populations labeling, FDA, February 6, 2024.
- BLA 103979/S-5309 supplement approval letter, traditional approval for patients 2 years and older, FDA, March 11, 2021.
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.