Naglazyme
Generic name:galsulfase [ gal-SUL-fase ]
Drug class:Lysosomal enzymes
What is Naglazyme?
Naglazyme 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.
Naglazyme 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.
Naglazyme may improve walking and stair-climbing ability in people with this condition. However, this medication is not a cure for MPS VI.
Warnings
An allergic reaction may occur during or shortly after the Naglazyme infusion. Tell your caregivers or get emergency medical help right away if you have any signs of a severe allergic reaction, such as chest pain, trouble breathing, vomiting, skin rash or redness, and feeling like you might pass out.
Before taking this medicine
Your Naglazyme infusion may be delayed if you have a fever or cold symptoms.
To make sure Naglazyme is safe for you, tell your doctor if you have ever had:
breathing problems; or
sleep apnea, and you use a continuous positive airway pressure (CPAP) machine.
Tell your doctor if you are pregnant or breastfeeding.
Your name may need to be listed on an MPS IV Registry while you are using Naglazyme. The purpose of this registry is to track the progression of this disorder and the effects that galsulfase has on long-term treatment of MPS IV. The registry also tracks the effects of galsulfase on a baby if you are pregnant or breastfeeding.
How is Naglazyme given?
Naglazyme is given as an infusion into a vein. A healthcare provider will give you this injection.
Naglazyme is usually given once per week.
Tell your doctor if you have been sick with a fever or cold. You may need to wait until you get better before receiving your dose of Naglazyme.
Naglazyme must be given slowly, and the infusion can take up to 4 hours to complete.
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 on a regular basis.
Dosing information
Usual Adult Dose for Mucopolysaccharidosis Type VI:
1 mg/kg IV once a we...
