Substance / Medication

Galsulfase

Overview

Active Ingredient
galsulfase
RxNorm CUI
578033

Indications

NAGLAZYME is indicated for patients with Mucopolysaccharidosis VI (MPS VI, Maroteaux-Lamy syndrome). NAGLAZYME has been shown to improve walking and stair-climbing capacity.

Labeler: BioMarin Pharmaceutical Inc.Updated: 2024-09-18T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

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. Initiate NAGLAZYME in a healthcare setting wi

Contraindications

When this intervention should not be used

None.

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Clinical Trials

1 trials linked to this intervention

1
Total Trials
0
Recruiting
1
With Results

Research Evidence

Published studies and systematic reviews

Sort:
Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI.
Brunelli Marcela Junqueira, Atallah Álvaro N, da Silva Edina Mk · Cochrane Database Syst Rev · 2021
PMID: 34533215Meta-AnalysisFull text (PMC)
Clinical effectiveness of enzyme replacement therapy with galsulfase in mucopolysaccharidosis type VI treatment: Systematic review.
Gomes Dalila Fernandes, Gallo Luciana Guerra, Leite Betânia Ferreira et al. · J Inherit Metab Dis · 2019
PMID: 30740728Meta-Analysis
Enzyme replacement therapy with galsulfase for mucopolysaccharidosis type VI.
Brunelli Marcela Junqueira, Atallah Álvaro N, da Silva Edina M K · Cochrane Database Syst Rev · 2016
PMID: 26943923Meta-Analysis
Is premedication a necessity before galsulfase replacement therapy?
Ercan Nazli, Bostanci Ilknur Birol, Ozmen Serap et al. · Ann Allergy Asthma Immunol · 2016
PMID: 27346567Case Report
Successful desensitization in a type VI mucopolysaccharidosis patient with probable IgE-mediated allergy to galsulfase [Naglazyme].
Bégin Philippe, Chapdelaine Hugo, Lemyre Emmanuelle et al. · Ann Allergy Asthma Immunol · 2013
PMID: 23244660Case Report
Thrombocytopenia associated with galsulfase treatment.
Doğan Murat, Cesur Yasar, Peker Erdal et al. · Hum Exp Toxicol · 2011
PMID: 20670992Case Report
Reversed papilledema in an MPS VI patient with galsulfase (Naglazyme) therapy.
Koseoglu Selim T, Harmatz Paul, Turbeville Sean et al. · Int Ophthalmol · 2009
PMID: 18418554Case ReportFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Galsulfase (substance)
SNOMED CT
419797001
UMLS CUI
C1615657
RxNorm CUI
578033
Labeler
BioMarin Pharmaceutical Inc.

Clinical Data

This intervention maps to 2 entities in the Healos knowledge graph.

2
Conditions
0
Biomarkers
0
Specialists
0
Symptoms
1
Clinical Trials

Data is sourced from SNOMED CT, UMLS, and the Healos clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.