Generic Name: galsulfase (gal SUL fase)Brand Names: 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.
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.
Before receiving galsulfase, tell your doctor if you are allergic to any drugs, or if you have:
sleep apnea (breathing stops during sleep);
a fever; or
flu symptoms, or a common cold.
If you have any of these conditions, you may need a dose adjustment or special tests to safely use galsulfase.
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.FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether galsulfase passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
Galsulfase is given as an injection through a needle placed into a vein. You will most likely receive this injection in a clinic or hospital setting. Galsulfase is usually given once per week.The medicine must be given slowly through an IV infusion, and can take up to 4 hours to complete.
Your doctor may also prescribe other medications to help prevent an allergic reaction to galsulfase. Take all of your medications as directed.
To be sure this medication is helping your condition and not causing harmful effects, your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
Contact your doctor if you miss an appointment for your galsulfase injection.
Symptoms of a galsulfase overdose are not known.
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are receiving galsulfase.
Less serious side effects may include:
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.
Usual Adult Dose for Mucopolysaccharidosis Type VI:
Dose: 1 mg/kg of body weight administered once weekly as an intravenous infusion.Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start or the infusion.
Usual Pediatric Dose for Mucopolysaccharidosis Type VI:
>= 5 years:Dose: 1 mg/kg of body weight administered once weekly as an intravenous infusion.Pretreatment with antihistamines with or without antipyretics is recommended 30 to 60 minutes prior to the start or the infusion.
There may be other drugs that can interact with galsulfase. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.