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-01066 v1.0