Velmanase Alfa-Tycv: uses, dosing, side effects & brands
Velmanase Alfa-Tycv is a medicine sold in the U.S. under one brand, for alpha-mannosidosis. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats
- Alpha-Mannosidosis
- Available as
- Injectable
- Sold as
- Lamzede
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How velmanase alfa-tycv is dosed
From the FDA label for Lamzede (application BLA761278). Other velmanase alfa-tycv products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
For females of reproductive potential, verify that the patient is not pregnant prior to initiating treatment. ( 2.1 ) Consider pretreating with antihistamines, antipyretics, and/or corticosteroids prior to LAMZEDE administration. ( 2.2 ) Recommended LAMZEDE dosage is 1 mg/kg (actual body weight) administered once every week as an intravenous infusion. ( 2.2 ) See the full prescribing information for dosage modifications due to hypersensitivity reactions or IARs. ( 2.3 ) See the full prescribing information for reconstitution and administration instructions. ( 2.4 , 2.5 ) 2.1 Important Recommendations Prior to LAMZEDE Treatment Initiation For females of reproductive potential, verify that the patient is not pregnant [see Use in Specific Populations ( 8.1 , 8.3 )] . 2.2 Recommended Dosage and Administration Prior to LAMZEDE administration, consider pre-treating with antihistamines, antipyretics, and/or corticosteroids [see Warnings and Precautions ( 5.1 , 5.2 )] . The recommended dosage of LAMZEDE is 1 mg/kg (actual body weight) administered once every week as an intravenous infusion. The total volume of infusion is determined by the patient’s actual body weight and should be administered over a minimum of 60 minutes for patients weighing up to 49 kg. Patients weighing 50 kg and greater should be infused at a maximum infusion rate of 25 mL/hour to control the protein load [ s ee…
Velmanase Alfa-Tycv side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Anaphylaxis [see Warnings and Precautions ( 5.1 )] Infusion-Associated Reactions (IARs) [see Warnings and Precautions ( 5.2 ) ] Most common adverse reactions (incidence > 20%) are hypersensitivity reactions including anaphylaxis ( 5.1 ), nasopharyngitis, pyrexia, headache, and arthralgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions F rom Trial 1 The safety of LAMZEDE was evaluated in Trial 1, which included a total of 15 LAMZEDE-treated patients (8 adult patients aged 18-35 years old and 7 pediatric patients aged 6-17 years old; 9 male, 6 female) with alpha-mannosidosis [see Clinical Studies ( 14 )]. All patients received LAMZEDE 1 mg/kg weekly via intravenous infusion for 52 weeks. A serious adverse reaction of acute renal failure was reported in 1 (7%) LAMZEDE-treated patient (see Description of Selected Adverse Reactions) . Table 1 lists…
Who shouldn’t take velmanase alfa-tycv
None. None. ( 4 )
Every velmanase alfa-tycv 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: Lamzede.
What people report to the FDA about velmanase alfa-tycv
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 1 reports naming velmanase alfa-tycv, and the FDA flagged 100% 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:
- chills1 reports
- infusion related reaction1 reports
- tremor1 reports
Read these as a signal, not a rate. A report does not mean velmanase alfa-tycv 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 26, 2026.
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Frequently asked questions
What is velmanase alfa-tycv?
Lamzede (Velmanase Alfa-Tycv) is a medication used to treat Alpha-Mannosidosis.
Can you take velmanase alfa-tycv 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 velmanase alfa-tycv 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 velmanase alfa-tycv come in?
Across the brands we track, velmanase alfa-tycv 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 velmanase alfa-tycv?
We do not currently list a generic-labelled velmanase alfa-tycv 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). Velmanase Alfa-Tycv: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/velmanase-alfa-tycv
- MLA
- “Velmanase Alfa-Tycv: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/velmanase-alfa-tycv.
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 velmanase alfa-tycv on DailyMed (NIH) ↗ — including its boxed warning in full.