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Naglazyme
Galsulfase
$2780.00
5mg/ml · 5 vial
BrandBranded medicine· By BioMarin
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FDA boxed warningHypersensitivity reactions including anaphylaxis
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Initiate NAGLAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue NAGLAZYME and immediately initiate appropriate medical treatment, including use of epinephrine.
Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.
About Naglazyme
Overview
Naglazyme is a prescription medicine containing galsulfase, an enzyme made using recombinant DNA technology. It treats mucopolysaccharidosis VI (MPS VI), also called Maroteaux-Lamy syndrome, and has been shown to improve walking and stair-climbing capacity. It works by supplying an enzyme that is missing or greatly reduced in MPS VI, helping cells break down substances called glycosaminoglycans that would otherwise build up in the body.
What it treats
Mucopolysaccharidosis VI (MPS VI), also known as Maroteaux-Lamy syndrome.
Safety information
Side effects
Common side effects include rash, pain, hives, fever, itching, chills, headache, nausea, vomiting, abdominal pain and shortness of breath. Infusion-related reactions are the side effects most often requiring medical intervention. Serious risks include severe allergic reactions, including anaphylaxis; immune-mediated reactions; sudden heart and breathing failure; acute breathing complications; and compression of the spinal cord in the back or neck. Seek immediate medical attention for a severe allergic reaction or sudden breathing difficulty, and contact your doctor promptly about other serious reactions. People susceptible to fluid overload need particular caution and monitoring during infusion. Sleep apnea is common in people with MPS VI, and antihistamines given before infusion may increase the risk of pauses in breathing. Medical monitoring and appropriate breathing support should be available during infusion.
FDA boxed warning
Hypersensitivity reactions including anaphylaxis
Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy.
Initiate NAGLAZYME in a healthcare setting with appropriate medical monitoring and support measures, including access to cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (e.g., anaphylaxis) occurs, discontinue NAGLAZYME and immediately initiate appropriate medical treatment, including use of epinephrine.
Inform patients of the symptoms of life-threatening hypersensitivity reactions, including anaphylaxis and to seek immediate medical care should symptoms occur.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
The label lists no contraindications for Naglazyme. Caution is needed in people at risk of fluid overload because of the risk of sudden heart and breathing failure. Appropriate medical monitoring and support should be available during infusion. Sleep apnea is common in people with MPS VI. Antihistamines given before the infusion may increase the risk of pauses in breathing, so appropriate breathing support should be available. Immune-mediated reactions can occur and require monitoring during treatment. Infusion reactions can also occur. The label recommends antihistamines before infusion, with or without fever-reducing medicines, to reduce this risk. If a reaction occurs, the healthcare team may slow or temporarily stop the infusion or give additional medicines.
Using Naglazyme
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label NAGLAZYME (GALSULFASE) SOLUTION [BIOMARIN PHARMACEUTICAL INC.] (DailyMed, retrieved 19 September 2026).
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