Prescription medicine
Velmanase alfa-tycv Brand names: Lamzede
Velmanase alfa-tycv (Lamzede) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the velmanase alfa-tycv FDA label on DailyMed (effective February 21, 2023, Chiesi USA, Inc.); the BLA 761278 record on Drugs@FDA; every velmanase alfa-tycv label on DailyMed.
Highlights of the record
FDA label of February 21, 2023; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SEVERE HYPERSENSITIVITY REACTIONS.
Hypersensitivity Reactions Including Anaphylaxis Patients treated with LAMZEDE have experienced hypersensitivity reactions, including anaphylaxis. Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available during LAMZEDE administration. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment. In patients with severe hypersensitivity reaction, a desensitization procedure to LAMZEDE may be considered [see Warnings and Precautions ( 5.1 )]. WARNING: SEVERE HYPERSENSITIVITY REACTIONS See full prescribing information for complete boxed warning. Hypersensitivity Reactions Including Anaphylaxis Appropriate medical support measures, including cardiopulmonary resuscitation equipment, should be readily available. If a severe hypersensitivity reaction occurs, discontinue LAMZEDE immediately and initiate appropriate medical treatment.
Used for
From the label: indications and usageINDICA TIONS AND USAGE LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.
Forms and strengths
- 10 mg
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- February 16, 2023 Lamzede, Chiesi Farmaceutici Spa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- 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
- 55 through July 30, 2026
What is velmanase alfa-tycv used for?
From the label: indications and usageINDICA TIONS AND USAGE LAMZEDE is indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients. LAMZEDE is recombinant human lysosomal alpha-mannosidase indicated for the treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients.
Source: FDA drug label (Lamzede), Chiesi USA, Inc., effective February 21, 2023 (SPL set 36d50a08-60bd-40eb-807c-778d69bf2d2e), via openFDA; the full label on DailyMed
Is there a generic for velmanase alfa-tycv (Lamzede)?
No generic velmanase alfa-tycv is approved (Drugs@FDA, October 8, 2026).
- 2023 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for velmanase alfa-tycv?
The FDA Adverse Event Reporting System holds 55 reports that list velmanase alfa-tycv 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 14 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?
- Velmanase alfa-tycv side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other