Galsulfase
- Atc Codes:A16AB08
- CAS Codes:552858-79-4
- PHARMGKB ID:552858-79-4
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Naglazyme; Belgium: Naglazyme; Bulgaria: Naglazyme; Czech Republic: Naglazyme; Denmark: Naglazyme; Estonia: Naglazyme; Germany: Naglazyme; Greece: Naglazyme; Hungary: Naglazyme; Ireland: Naglazyme; Italy: Naglazyme; Latvia: Naglazyme; Netherlands: Naglazyme; Poland: Naglazyme; Portugal: Naglazyme; Romania: Naglazyme; Slovakia: Naglazyme; Spain: Naglazyme; Sweden: Naglazyme.
North America
USA: Naglazyme.
Asia
Japan: Naglazyme.
Drug combinations
Chemistry
Galsulfase: C~2529~H~3843~N~689~O~716~S~16~. Mw: approx. 55833.10. N-Acetylgalactosamine 4-sulfatase (human CSL4S-342 cell). CAS-552858-79-4 (2004).
Pharmacologic Category
Enzymes. (ATC-Code: A16AB08).
Mechanism of action
Galsulfase is a recombinant form of N-acetylgalactosamine 4-sulfatase, produced in Chinese hamster cells. Deficiency of this enzyme leads to accumulation of glycosaminoglycan dermatan sulfate in various tissues. Replacement of this enzyme shown to improve mobility and physical function.
Therapeutic use
Replacement therapy in mucopolysaccharidosis VI (MPS VI; Maroteaux-Lamy Syndrome) for improvement of walking and stair-climbing capacity.
Pregnancy and lactiation implications
Fetal harm not reported in animal studies. There are no studies in pregnant women. Unknown whether galsulfase is distributed into milk. Use with caution in nursing women.
Unlabeled use
Contraindications
Hypersensitivity to galsulfase or any component of formulation.
Warnings and precautions
Infusion-related reactions might occur (may be severe). Delay of treatment recommended in acute febrile or respiratory illness. Pre-treatment with antihistamines may increase risk of apneic episodes.