Prescription medicine
Olipudase alfa Brand names: Xenpozyme
Olipudase alfa (Xenpozyme) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the olipudase alfa FDA label on DailyMed (effective December 11, 2025); every olipudase alfa label on DailyMed.
Highlights of the record
FDA label of December 11, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS.
Patients treated with XENPOZYME have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available during XENPOZYME administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reactions, a desensitization procedure to XENPOZYME may be considered [see Warnings and Precautions (5.1) ]. WARNING: HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS See full prescribing information for complete boxed warning. Appropriate medical monitoring and support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue XENPOZYME immediately and initiate appropriate medical treatment.
Used for
From the label: indications and usageXENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.
Forms and strengths
- 4 mg/1.1ml
- 20 mg/5.1ml
Injection (powder) (lyophilized) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 123 through July 30, 2026
What is olipudase alfa used for?
From the label: indications and usageXENPOZYME is indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. XENPOZYME is a hydrolytic lysosomal sphingomyelin-specific enzyme indicated for treatment of non–central nervous system manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients.
Source: FDA drug label (XENPOZYME), Genzyme Corporation, effective December 11, 2025 (SPL set 01a910ee-a33e-4be3-ac41-322d64c34311), via openFDA; the full label on DailyMed
Is there a generic for olipudase alfa (Xenpozyme)?
No generic olipudase alfa is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the olipudase alfa label say about other medicines?
The olipudase alfa label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Fingolimod | warnings and precautions | However, published literature reports that early embryonic exposure to a metabolite of sphingomyelin (ceramide) or the S1P receptor modulator fingolimod can produce exencephaly in chicks and mice, respectively. |
Source: FDA drug label (XENPOZYME), Genzyme Corporation, effective December 11, 2025 (SPL set 01a910ee-a33e-4be3-ac41-322d64c34311), via openFDA; the full label on DailyMed
What do FAERS reports show for olipudase alfa?
The FDA Adverse Event Reporting System holds 123 reports that list olipudase alfa among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 18 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Olipudase alfa side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other