Molecule
Galsulfase is a hydrolytic lysosomal glycosaminoglycan-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). It is available as injection for intravenous use. MedsAcross supplies Galsulfase for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity. NAGLAZYME is a hydrolytic lysosomal glycosaminoglycan (GAG)-specific enzyme indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome).
Source: US FDA prescribing information
Mucopolysaccharide storage disorders are caused by the deficiency of specific lysosomal enzymes required for the catabolism of GAG. MPS VI is characterized by the absence or marked reduction in N-acetylgalactosamine 4-sulfatase. The sulfatase activity deficiency results in the accumulation of the GAG substrate, dermatan sulfate, throughout the body. This accumulation leads to widespread cellular, tissue, and organ dysfunction. NAGLAZYME is intended to provide an exogenous enzyme that will be taken up into lysosomes and increase the catabolism of GAG. Galsulfase uptake by cells into lysosomes is most likely mediated by the binding of mannose-6-phosphate-terminated oligosaccharide chains of galsulfase to specific mannose-6-phosphate receptors.
Source: US FDA prescribing information
Administration of NAGLAZYME should be supervised by a healthcare provider knowledgeable in the management of hypersensitivity reactions including anaphylaxis. The recommended dosage is 1 mg per kg of body weight administered once weekly as an intravenous infusion.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Boxed warning (hypersensitivity reactions including anaphylaxis): Patients treated with enzyme replacement therapies have experienced life-threatening hypersensitivity reactions, including anaphylaxis. Anaphylaxis has occurred during the early course of enzyme replacement therapy and after extended duration of therapy. Immune-Mediated Reactions: Immune-mediated reactions can occur with NAGLAZYME. Monitor patients for the development of immune complex-mediated reactions while receiving NAGLAZYME. Risk of Acute Cardiorespiratory Failure: Caution should be exercised when administering NAGLAZYME to patients susceptible to fluid volume overload. Consider a decreased total infusion volume and infusion rate when administering NAGLAZYME to these patients. Appropriate medical monitoring and support measures should be available during infusion.
Source: US FDA prescribing information
Serious and/or clinically significant adverse reactions described elsewhere in labeling include: Hypersensitivity Reactions Including Anaphylaxis Immune-Mediated Reactions Risk of Acute Cardiorespiratory Failure Acute Respiratory Complications Associated with Administration Infusion Reactions Spinal or Cervical Cord Compression The most common adverse reactions (≥10%) are: rash, pain, urticaria, pyrexia, pruritus, chills, headache, nausea, vomiting, abdominal pain and dyspnea. The most common adverse reactions requiring interventions are infusion-related reactions.
Source: US FDA prescribing information
Store NAGLAZYME under refrigeration at 2°C to 8°C (36°F to 46°F). Do not freeze or shake. Protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Galsulfase, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Naglazyme 5 mg/5 mL injectionIntravenous Cold chain | BioMarin Pharmaceutical | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Galsulfase and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Galsulfase, including Naglazyme.
Yes. The US FDA first approved Galsulfase on 31 May 2005, according to Drugs@FDA.
Yes. Galsulfase has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Galsulfase must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Galsulfase is classified under ATC code A16AB08 (Galsulfase).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.