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Galsulfase

Generic Name: Galsulfase ([gal-SULfase])
Brand Name: Naglazyme
Drug class: Lysosomal enzymes

What is Galsulfase?

In healthy individuals, the enzyme galsulfase is naturally present in their bodies. AGenetic disorders may make some individuals lack this enzyme; galsulfase supplements provide replacement of what's missing for these people. Galsulfase can help treat some symptoms associated with mucopolysaccharidosis VI (pronounced MYOO-koe-pol-ee-SAK-a-rye-DOE-sis type 6), more commonly referred to as Maroteaux-Lamy syndrome or MPS VI. MPS VI is a metabolic disorder where the body does not have the enzymes required to break down some natural substances. These substances can accumulate in the body and cause enlarged organs or abnormal bone structure. They may also lead to breathing problems, heart issues, vision problems, or loss of hearing. Galsulfase can improve the ability to walk and climb stairs in those with this condition. This medication is not a treatment for MPS VI. This medication guide does not list all possible uses of galsulfase.

Side effects of Galsulfase

If you experience any of the following signs and symptoms of an allergic reaction: difficulty breathing, hives or swelling to face lips throat A severe allergic reaction can occur immediately after or during the infusion of galsulfase. This could happen up to 24 hours later. If you experience any of the following symptoms, tell your caregivers immediately or seek emergency medical attention.

  • Rapid breathing or feeling short-breath;
  • Chest pain;
  • Feeling like you could pass out even when lying down
  • Fever, chills;
  • Itching skin or a rash
  • Eye redness;
  • Headache;
  • Vomiting, and stomach pain.

Galsulfase may not cause this side effect, but it can lead to increased pressure on your spinal cord. If you experience any of the following symptoms, tell your doctor immediately: backache; loss of mobility in any part of your body; loss of bladder or bowel control

The side effects of galsulfase can be serious. If you experience:

  • Snoring or sleep apnea; difficulty breathing
  • Rapid weight gain and swelling
  • Shortness of breath (even when mild exertion is undertaken)

Some of the common side effects associated with galsulfase include:

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

There may be other side effects. For medical advice on side effects, call your doctor. Contact the FDA by dialing 1-800-FDA-1088 in order to report adverse side effects.

Similar/related drugs

Naglazyme

Warnings

A severe allergic reaction can occur during infusion or soon after. If you experience any symptoms of an allergic reaction, including chest pain, difficulty breathing, nausea, skin rash, or redness and the feeling that you may pass out, immediately tell your caregivers.

Before you take this drug

If you have a cold or fever, your galsulfase may be delayed.

Be sure to inform your physician of any of the following issues:

  • Breathing problems
  • You have sleep apnea and use a continuous-positive airway pressure machine (CPAP).

Inform your physician immediately if you become pregnant or nursing. You may be required to list your name on a registry while using galsulfase. This registry was created to monitor the progression of MPS IV and its effects on galsulfase over time. This registry tracks galsulfase's effects on your baby, if you are breastfeeding or pregnant.

How to take Galsulfase?

An injection of galsulfase into the vein is administered. This injection will be given by a healthcare provider. Galsulfase can be given once a week. Inform your doctor if you've been ill with a cold or fever. It may be necessary to wait until your symptoms improve before you receive your galsulfase dose. The infusion of galsulfase can take as long as 4 hours. You will receive other medications 30–60 minutes before the injection to prevent an allergic reaction. You will need to have your doctor check on you regularly.

Details on dosage

Usual Adult Dose for Mucopolysaccharidosis Type VI:
1 mg/kg IV every week
Comments:
The clinical studies did not include older patients, and therefore it is unknown whether they react differently to younger patients.
Utilization: Used in the treatment of patients suffering from Mucopolysaccharidosis VI (MPS VI [Maroteaux-Lamy syndrome]).
Usual Pediatric Dose for Mucopolysaccharidosis Type VI:
5 years and older: 1 mg/kg IV every week
Use: To treat patients with MPS VI (Maroteaux Lamy Syndrome).

What happens if I miss the dose?

If you are unable to attend your appointment for the galsulfase shot, call your doctor.

What happens if I overdose?

Overdoses are unlikely because this medication is administered by a health professional in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions involving food, beverages or activity, follow their orders exactly.

Interaction with other drug

Galsulfase can be affected by other drugs, such as vitamins and herbal products. Inform your physician of all medications you are currently taking or have begun or discontinued using.