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ALIMENTARY TRACT AND METABOLISM › OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS › OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS › Enzymes
galsulfase
A16AB08
Forms & Strengths
- Injection: 5 mg/5 mL (1 mg/mL) in single-use vials
Adult Dosing
- 1 mg/kg body weight administered once weekly as an intravenous infusion
Pediatric Dosing
- 1 mg/kg body weight administered once weekly as an intravenous infusion (safety and efficacy established in patients 5 years and older, though used in younger patients based on clinical necessity)
Indications
- Enzyme replacement therapy for patients with Mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy syndrome)
Mechanism of Action
- Recombinant human N-acetylgalactosamine 4-sulfatase (rhASase) catalyzes the hydrolysis of the sulfate ester group of N-acetylgalactosamine 4-sulfate from glycosaminoglycans (GAG) dermatan sulfate and chondroitin 4-sulfate, reducing cellular GAG accumulation
Contraindications
- Life-threatening hypersensitivity reactions to galsulfase or any of its excipients that cannot be successfully managed
Adverse Reactions
- Anaphylaxis and severe allergic reactions
- Infusion reactions (fever, chills, rash, urticaria, dyspnea)
- Respiratory distress and apnea
- Abdominal pain, nausea, vomiting
- Arthralgia, back pain, pain in extremity
- Headache, dizziness
Drug Interactions
- Formal clinical drug interaction studies have not been performed with galsulfase
- Potential for hypersensitivity reactions when co-administered with other immunomodulating therapies
Curated Content: Needs Vetting Before Put to Clinical Use