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Generic name: Galsulfase [gal-SUL-fase] Drug class: lysosomal enzymes

What is Naglazyme?

Naglazyme contains an enzyme that is naturally present in healthy individuals. Certain people are deficient in this enzyme due to a genetic condition. Galsulfase assists in replacing this lacking enzyme in these people.

MPS VI is a metabolic disorder that occurs when the body is deficient in the enzyme that is needed to break down certain natural substances. These substances may build up in the body, which can cause the growth of organs, abnormal bones, changes to the facial appearance, breathing issues, heart issues, vision loss, loss of hearing, and changes in physical or mental capabilities.

Naglazyme could increase the speed of walking and stair-climbing for those suffering from this condition. It is important to note that the medication does not provide an effective treatment for MPS VI.


A reaction to an allergen can occur in the course of or immediately following a Naglazyme infusion. Contact your doctor or seek medical attention immediately if you exhibit any symptoms of a reaction to an allergic substance, such as chest discomfort, difficulty breathing, vomiting, a skin rash, or the sensation that you're about to faint.

Before you Take this Drug

Your Naglazyme infusion could be delayed if you suffer from an illness that causes a fever or symptoms of a cold.

To ensure that Naglazyme is suitable for you, ask your doctor if you've previously had:

  • Breathing issues
  • Sleep apnea, which is caused by the continuous positive pressure (CPAP) machine.

Inform your doctor if you are nursing or pregnant.

Your name might have to be included in some kind of MPS IV registry while you use Naglazyme. The goal of this register is to monitor the development of this disorder as well as the impact that galsulfase effects have on the long-term treatment of MPS IV. The registry also studies its effects on the baby if you're nursing or pregnant.

How to Take Naglazyme?

Naglazyme is administered as an injection into the vein. The healthcare professional will give the injection.Naglazyme is typically administered once per week.Inform your doctor if you are suffering from a cold or fever. You might need to wait until you feel better before you can receive the dosage of Naglazyme.

Naglazyme should be administered slowly, and the infusion could take up to 4 hours to be completed.

Between 30 and 60 minutes prior to the injection, you'll be administered other medicines to prevent an allergic reaction.Your doctor should monitor your health regularly.

Details on Dosage

Usual Adult Dose for Mucopolysaccharidosis Type VI:

1 mg/kg IV twice each week
Clinical studies did not contain patients over the age of 29, and therefore it is not known how they will react to younger patients.
Use: For the treatment of patients with Mucopolysaccharidosis VI (MPS VI [Maroteaux-Lamy syndrome]).

Usual Paediatric Dose for Mucopolysaccharidosis Type VI:

5 years and older 1 mg/kg intravenous at least once per week
Use: To treat patients suffering from MPS VI (Maroteaux-Lamy syndrome).

What Happens If I Miss a Dose?

Consult your physician for the proper treatment. If you do not make an appointment to receive an appointment for Naglazyme injection,

What Happens If I Overdose?

Because this medication is administered by a medical specialist in a medical setting, it is highly unlikely for an overdose to occur.

What Should be Avoided?

Follow the doctor's advice regarding any dietary restrictions, drinks, food, or any activity.

Side effects of Naglazyme

See a doctor immediately. If you are experiencing symptoms that indicate you are experiencing an allergic reaction, Naglazyme: hives, breathing problems, or swelling of your lips, face, or tongue.

A reaction to an allergen can occur within or just after the infusion (up to 24 hours later). Contact your doctor or seek medical attention immediately if you exhibit any indication of an allergy, such as:

  • Rapid breathing or feeling breathless;
  • Chest pain;
  • The feeling that you are about to be struck, even sitting down
  • Fever, chills;
  • The skin, redness, or itching
  • Eye redness;
  • Headache
  • Vomiting, and stomach pain.

While it could be a result of galsulfase, increased stress on the spine is an aspect of MPS VI that can occur during the use of Naglazyme. Contact your physician immediately if you notice any signs of compression on your spinal cord, such as back pain, loss of movement anywhere on your body, or loss of bladder or bowel control.

Contact your doctor immediately. If you are suffering from:

  • Sleep apnea or snoring; trouble breathing
  • Swelling or rapid weight gain;
  • Breath shortness (even when exerting only a little).

Common Naglazyme side effects can include:

  • Fever, chills;
  • Trouble breathing
  • Pain;
  • Itching or rash;
  • Headaches
  • Nausea, vomiting, and stomach pain.

This isn't a complete list of all the side effects. Other effects may also be present. Consult your physician to seek medical advice on the effects. You can report any side effects to the FDA at 1-800-FDA-1088.

Interaction with Other Drugs

Other drugs can affect galsulfase's effects, including prescription and non-prescription medicines, vitamins, and herbal products. Inform your doctor about the medicines you are currently taking and any medications you begin or stop taking.