Lamzede® velmanase alfa-tycv

INDICATION

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

Important Safety
Information

What is the most important
information I should know about
Lamzede?

Severe allergic reactions
(hypersensitivity reactions)
including anaphylaxis, may
occur during and after Lamzede
treatment. If severe allergic
reactions or anaphylaxis occur
during treatment, your healthcare
provider will immediately stop the
infusion and provide appropriate
medical care. If these reactions
should occur after treatment, seek
immediate medical care.

What should I know about
infusions?

Your healthcare provider may
give you other medications prior
to your next infusion to help
manage allergic reactions and
infusion-related side effects. They
will explain how to recognize the
signs and symptoms of these
allergic reactions and infusion-
related side effects. If these
signs and symptoms occur,
it’s important for you to seek
immediate medical care.

What are the common signs and
symptoms of an allergic reaction or
infusion-related side effects with
Lamzede?

In clinical trials, some patients
experienced signs and symptoms
of an allergic reaction, which
included bluish skin discoloration,
low blood pressure, vomiting,
hives, skin redness, facial
swelling, fever, and involuntary
movements.

In clinical trials, when patients
experienced an infusion-related
side effect, the most common
signs were fever, chills, skin
redness, vomiting, cough, itching,
rash, and pink eye.

Are there certain people who
should or should not take
Lamzede?

Lamzede may cause harm to your
unborn baby. For females who are
able to become pregnant, your
healthcare provider should do a
pregnancy test before you start
treatment with Lamzede. Tell your
healthcare provider right away
if you become pregnant or think
you may be pregnant. You should
use effective birth control during
treatment with Lamzede and for
at least 14 days after the last
dose.

What are the most common side
effects of Lamzede?

Lamzede can cause side effects
including severe allergic reactions
and anaphylaxis, common cold,
fever, headache, and joint pain or
stiffness.

Please see Full Prescribing
Information for Lamzede at
Lamzede.com.

You are encouraged to report
negative side effects of
prescription drugs to the FDA.
Visit www.fda.gov/medwatch or
call 1-800-FDA-1088.

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

PP-RA-01067 v1.0