Naglazyme

DRUG DESCRIPTION

NAGLAZYME is a formulation of galsulfase, which is a purified human enzyme that is produced by recombinant DNA technology in a Chinese hamster ovary cell line. Galsulfase (glycosaminoglycan Nacetylgalactosamine 4-sulfatase, EC 3.1.6.12) is a lysosomal enzyme that catalyzes the cleavage of the sulfate ester from terminal N-acetylgalactosamine 4-sulfate residues of glycosaminoglycans (GAG), chondroitm 4-sulfate and dermatan sulfate.

Galsulfase is a glycoprotein with a molecular weight of approximately 56 kDa. The recombinant protein consists of 495 amino acids and possesses six asparagine-linked glycosylation sites, four of which carry a bis-mannose-6-phosphate residue for specific cellular recognition. Post-translational modification of Cys53 produces the catalytic amino acid residue, Ca-formylglycine, which is required for enzyme activity. NAGLAZYME has a specific activity of approximately 70 units per mg of protein content. One activity unit is defined as the amount of enzyme required to convert 1 micromole of 4-methylumbelliferyl sulfate to 4- methylumbelliferone and free sulfate per minute at 37C.

NAGLAZYME is intended for intravenous infusion and is supplied as a sterile, nonpyrogenic, colorless to pale yellow, clear to slightly opalescent solution that must be diluted with 0.9% Sodium Chloride Injection, USP, prior to administration. NAGLAZYME is supplied in clear Type I glass 5 mL vials. Each vial provides 5 mg galsulfase, 43.8 mg sodium chloride, 6.20 mg sodium phosphate monobasic monohydrate, 1.34 mg sodium phosphate dibasic heptahydrate, and 0.25 mg polysorbate 80 in a 5 mL extractable solution with pH of approximately 5.8. NAGLAZYME does not contain preservatives. Each vial is for single use only.

What are the possible side effects of galsulfase (Naglazyme)?

Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side...

Read All Potential Side Effects and See Pictures of Naglazyme


Naglazyme Patient Information Including Side Effects

Brand Names: Naglazyme

Generic Name: galsulfase (Pronunciation: gal SUL fase)

  • What is galsulfase (Naglazyme)?
  • What are the possible side effects of galsulfase (Naglazyme)?
  • What is the most important information I should know about galsulfase (Naglazyme)?
  • What should I discuss with my health care provider before receiving galsulfase (Naglazyme)?
  • How is galsulfase given (Naglazyme)?
  • What happens if I miss a dose (Naglazyme)?
  • What happens if I overdose (Naglazyme)?
  • What should I avoid while receiving galsulfase (Naglazyme)?
  • What other drugs will affect galsulfase (Naglazyme)?
  • Where can I get more information?

What is galsulfase (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.

What are the possible side effects of galsulfase (Naglazyme)?

Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects may include:

  • headache;
  • joint pain;
  • eye redness;
  • 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.

What is the most important information I should know about galsulfase (Naglazyme)?

Galsulfase may improve walking and stair-climbing ability in people with Maroteaux-Lamy syndrome. However, galsulfase is not a cure for this condition.

Some people receiving a galsulfase injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you have a headache, fever or chills, skin rash, itching, nausea, vomiting, stomach pain, pain in your chest, trouble breathing, or if you feel like you might pass out when galsulfase is injected.

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.

Related Drug Centers
  • Naglazyme


Related Drugs Index: