Agalsidase Beta: uses, dosing, side effects & brands
Agalsidase Beta is a medicine sold in the U.S. under one brand, for fabry disease. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Fabry Disease
- Available as
- Injectable
- Sold as
- Fabrazyme
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How agalsidase beta is dosed
From the FDA label for Fabrazyme (application BLA103979). Other agalsidase beta products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Administration of FABRAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. ( 2.1 ) The recommended dosage is 1 mg/kg body weight given every two weeks as an intravenous infusion. ( 2.2 ) See the full prescribing information for rechallenge, preparation, storage, and administration instructions. ( 2.3 , 2.4 , 2.5 , 2.6 ) 2.1 Recommendations Prior to FABRAZYME Treatment Administration of FABRAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis [see Warnings and Precautions (5.1) ]. Initiate FABRAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment [see Warnings and Precautions (5.1) ]. Prior to FABRAZYME administration, consider pretreating with antihistamines, antipyretics, and/or corticosteroids [see Warnings and Precautions (5.1 , 5.2) ] . FABRAZYME must be reconstituted and diluted prior to use [see Dosage and Administration (2.4) ] 2.2 Recommended Dosage and Administration The recommended dosage of FABRAZYME is 1 mg/kg body weight infused every two weeks as an intravenous infusion. The initial recommended infusion rate is 0.25 mg/min (15 mg/hour) [see Dosage and Administration (2.6) ] . 2.3 Rechallenge Instructions…
Agalsidase Beta side effects
The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions (5.1) ] Infusion-Associated Reactions [see Warnings and Precautions (5.2) ] Most common adverse reactions (≥20%) are: upper respiratory tract infection, chills, pyrexia, headache, cough, paresthesia, fatigue, peripheral edema, dizziness, and rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genzyme at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in patients in clinical practice. The data described below reflect exposure of 80 patients, ages 16 to 61 years, to 1 mg/kg FABRAZYME every two weeks in two separate double-blind, placebo-controlled clinical trials, for periods ranging from 1 to 35 months (mean 15.5 months). All 58 patients enrolled in one of the two studies continued into an open-label extension study of FABRAZYME treatment for up to 54 additional months. Patients were treated with antipyretics and antihistamines prior to the infusions. Most Common Adverse Reactions Table 2 enumerates adverse…
Who shouldn’t take agalsidase beta
None. None. ( 4 )
Every agalsidase beta product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Fabrazyme.
Agalsidase Beta and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for agalsidase beta: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of agalsidase beta during breastfeeding. Because it is a large protein molecule with a molecular weight of about 100,000 Da, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Six infants who were breastfed for periods up to 12 months by mothers taking the closely related drug agalsidase alfa experienced no adverse effects associated with the drug.
National Institute of Child Health and Human Development, record revised August 15, 2023. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about agalsidase beta
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 652 reports naming agalsidase beta, and the FDA flagged 75% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- fatigue102 reports
- malaise98 reports
- pain in extremity66 reports
- pyrexia61 reports
- dyspnoea60 reports
- headache58 reports
- dizziness56 reports
- nausea56 reports
Read these as a signal, not a rate. A report does not mean agalsidase beta caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is agalsidase beta?
Fabrazyme (Agalsidase Beta) is a medication used to treat Fabry Disease.
Can you take agalsidase beta with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run agalsidase beta against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does agalsidase beta come in?
Across the brands we track, agalsidase beta is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic agalsidase beta?
We do not currently list a generic-labelled agalsidase beta product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Agalsidase Beta: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/agalsidase-beta
- MLA
- “Agalsidase Beta: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/agalsidase-beta.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for agalsidase beta on DailyMed (NIH) ↗ — including its boxed warning in full.