Galsulfase
Generic name: galsulfase [ gal-SUL-fase ]
Brand name: Naglazyme
Dosage form: intravenous solution (1 mg/mL)
Drug class:Lysosomal enzymes
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.
Warnings
An allergic reaction may occur during or shortly after infusion of galsulfase. 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 galsulfase infusion may be delayed if you have a fever or cold symptoms.
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 this medicine. 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 galsulfase given?
Galsulfase is given as an infusion into a vein. A healthcare provider will give you this injection.
Galsulfase 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 galsulfase.
Galsulfase must be given slowly, and the infusion can take up to 4 hours to complete.
