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

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 populationwere 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.

PP-RA-01068 v1.0