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🏅 FDA Orphan Designation

Lamzede

VELMANASE ALFA-TYCV

Manufacturer: Chiesi USA, Inc.

Indicated for:
Alpha-mannosidosisOrphan
⚠️

Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (1)

Alpha-mannosidosisOrphan Designation

Treatment of non-neurological manifestations of alpha-mannosidosis in adult and pediatric patients 4 years of age and older. Enzyme replacement therapy with velmanase alfa.

Indications & Usage

1 INDICA 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. ( 1 )

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Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.