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Generic Name: galsulfase (gal SUL fase)
Brand Name: Naglazyme

What is galsulfase?

Galsulfase contains an enzyme that occurs naturally in the body in healthy people. Some people lack this enzyme because of a genetic disorder. Galsulfase helps replace this missing enzyme in such people.

Galsulfase is used to treat some of the symptoms of a genetic condition called mucopolysaccharidosis VI (MYOO-koe-pol-ee-SAK-a-rye-DOE-sis type 6), or MPS VI, also called Maroteaux-Lamy syndrome.

MPS VI is a metabolic disorder in which the body lacks the enzyme needed to break down certain natural substances. 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 MPS VI.

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

Important Information

Some side effects may occur during the galsulfase infusion, or up to 24 hours afterward. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or if you have hives, chest pain, stomach pain, fever, trouble breathing, eye irritation, or swelling in your face.

Before taking this medicine

You should not use this medication if you are allergic to galsulfase.

To make sure galsulfase is safe for you, tell your doctor if you have:

Your name may need to be listed on a MPS VI Registry while you are using this medicine. The purpose of this registry is to track the progression of this disorder and the effects that galsulfase has in long-term treatment.

Galsulfase is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether galsulfase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is galsulfase given?

Galsulfase is injected into a vein through an IV. You will most likely receive this injection in a clinic or hospital setting.

Galsulfase must be given slowly through an IV infusion, and can take at least 4 hours to complete.

Galsulfase is usually given once per week. Follow your doctor's instructions.

About 30 to 60 minutes before each injection, you will be given other medications to help prevent a serious allergic reaction.

Your doctor will need to check your progress while you are using galsulfase.

What happens if I miss a dose?

Call your doctor for instructions if you miss an appointment for your galsulfase injection.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving galsulfase?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Galsulfase side effects

Some side effects may occur during the galsulfase infusion, or up to 24 hours afterward. Tell your caregiver right away if you feel dizzy, light-headed, itchy, or if you have hives, chest pain, stomach pain, fever, trouble breathing, eye irritation, or swelling in your face.

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

Even though it may not be a side effect of galsulfase, increased pressure on the spinal cord is a complication of MPS VI that may occur while you are using galsulfase. Tell your doctor right away if you have any symptoms of spinal cord compression: back pain, loss of movement in any part of your body, loss of bowel or bladder control.

Call your doctor at once if you have:

  • snoring or sleep apnea, trouble breathing;

  • shortness of breath (even with mild exertion);

  • swelling, rapid weight gain;

  • eye redness; or

  • fever, chills, flu symptoms, pale skin, easy bruising or bleeding, unusual weakness.

Common side effects may include:

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.

See also: Side effects (in more detail)

Galsulfase dosing information

Usual Adult Dose for Mucopolysaccharidosis Type VI:

1 mg/kg IV once a week

-Clinical studies did not include patients older than 29 years and it is therefore unknown if they respond differently than younger patients.

Use: For the treatment of patients with Mucopolysaccharidosis VI (MPS VI [Maroteaux-Lamy syndrome])

Usual Pediatric Dose for Mucopolysaccharidosis Type VI:

5 years or older: 1 mg/kg IV once a week

Use: For the treatment of patients with MPS VI (Maroteaux-Lamy syndrome)

What other drugs will affect galsulfase?

Other drugs may interact with galsulfase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about galsulfase.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.02.

Date modified: March 06, 2018
Last reviewed: November 30, 2017