INDICATION

Lamzede® (velmanase alfa-tycv) is indicated for the treatment of non-central nervous
system manifestations of alpha-mannosidosis in adult and pediatric patients.

Important Safety Information

WARNING: 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.

Considerations Due to Hypersensitivity Reactions and/or
Infusion-Associated Reactions (IARs)

Prior to Lamzede administration, consider pretreating with antihistamines,
antipyretics, and/or corticosteroids. Inform patients and caregivers of the signs
and symptoms of hypersensitivity reactions and IARs and instruct them to seek
medical care immediately if such symptoms occur.

  • If a severe hypersensitivity reaction (including anaphylaxis) or severe IAR
    occurs, immediately discontinue Lamzede administration and initiate
    appropriate medical treatment.
  • In the event of a mild to moderate hypersensitivity reaction or a mild to
    moderate IAR, consider temporarily holding the infusion for 15 to 30
    minutes, slowing the infusion rate to 25% to 50% of the recommended rate,
    and initiating appropriate medical treatment.

Hypersensitivity Reactions Including Anaphylaxis

Anaphylaxis and severe hypersensitivity signs and symptoms included cyanosis,
hypotension, emesis, urticaria, erythema, facial swelling, pyrexia, and tremor.

Infusion-Associated Reactions (IARs)

The most frequent symptoms of IARs that occurred in >10% of the population
were pyrexia, chills, erythema, vomiting, cough, urticaria, rash, and conjunctivitis.

Females of Reproductive Potential

Advise females of reproductive potential to use effective contraception during
treatment and for 14 days after the last dose if Lamzede is discontinued. For
females of reproductive potential, verify that the patient is not pregnant prior to
initiating treatment with Lamzede.

Embryo-Fetal Toxicity

Based on findings from animal reproduction studies, Lamzede may cause
embryo-fetal harm when administered to a pregnant female.

Common Adverse Reactions

The most common adverse reactions (incidence >20%) are hypersensitivity
reactions including anaphylaxis, nasopharyngitis, pyrexia, headache, and
arthralgia.

Please see Full Prescribing Information for Lamzede, including Boxed Warning,
at lamzede.com.

©Chiesi USA, Inc. 2025. All rights reserved.

Lamzede® is a registered trademark of CHIESI FARMACEUTICI S.p.A.

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