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Brand Names: Naglazyme

Generic Name: galsulfase (Pronunciation: gal SUL fase)

• What is galsulfase (Naglazyme)?
• What are the possible side effects of galsulfase (Naglazyme)?
• What is the most important information I should know about galsulfase (Naglazyme)?
• What should I discuss with my health care provider before receiving galsulfase (Naglazyme)?
• How is galsulfase given (Naglazyme)?
• What happens if I miss a dose (Naglazyme)?
• What happens if I overdose (Naglazyme)?
• What should I avoid while receiving galsulfase (Naglazyme)?
• What other drugs will affect galsulfase (Naglazyme)?
• Where can I get more information?

What is galsulfase (Naglazyme)?

Galsulfase is used to treat some of the symptoms of a genetic condition called Maroteaux-Lamy syndrome. Maroteaux-Lamy syndrome is also called mucopolysaccharidosis (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis).

Maroteaux-Lamy syndrome is a metabolic disorder in which the body lacks the enzyme needed to break down certain sugars and proteins. These substances can build up in the body, causing enlarged organs, abnormal bone structure, changes in facial features, breathing problems, heart problems, vision or hearing loss, and changes in mental or physical abilities.

Galsulfase may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for Maroteaux-Lamy syndrome.

Galsulfase may also be used for other purposes not listed in this medication guide.

What are the possible side effects of galsulfase (Naglazyme)?

Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

• headache;
• joint pain;
• eye redness;
• nausea, vomiting, stomach pain, diarrhea;
• runny or stuffy nose, sore throat, cough, ear pain; or
• pain, redness, swelling, or other irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about galsulfase (Naglazyme)?

Galsulfase may improve walking and stair-climbing ability in people with Maroteaux-Lamy syndrome. However, galsulfase is not a cure for this condition.

Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

Your name may need to be listed on a patient registry while you are using this medication. The purpose of this registry is to track the progression of this disorder and the effects that galsulfase has on long-term treatment of Maroteaux-Lamy syndrome.

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