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.

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