Lamzede® velmanase alfa-tycv

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.

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

PP-RA-01068 v1.0