Agalsidase Alpha

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


Austria: Replagal; Belgium: Replagal; Bulgaria: Replagal; Cyprus: Replagal; Czech Republic: Replagal; Denmark: Replagal; Estonia: Replagal; Finland: Replagal; France: Replagal; Germany: Replagal; Greece: Replagal; Hungary: Replagal; Ireland: Replagal; Italy: Replagal; Latvia: Replagal; Lithuania: Replagal; Luxembourg: Replagal; Malta: Replagal; Netherlands: Replagal; Poland: Replagal; Portugal: Replagal; Romania: Replagal; Slovakia: Replagal; Slovenia: Replagal; Spain: Replagal; Sweden: Replagal; UK: Replagal.

North America

Canada: Replagal.


Japan: Replagal.

Drug combinations


Agalsidase Alpha: C~2029~H~3080~N~544~O~587~S~27~ (subunit protein moiety reduced). Mw: approx. 45351.01 daltons. (1) Galactosidase, α – (human clone λAG^18^ isoenzyme A subunit protein moiety reduced); (2) λ-Galactosidase (human-clone λAG^18^ isoenzyme A subunit protein moiety reduced). CAS-104138-64-9 (2000).

Pharmacologic Category

Enzymes. (ATC-Code: A16AB03).

Mechanism of action

Catalyzes the hydrolysis of globotriaosylceramide (Gb-3) and other glycosphingolipids.

Therapeutic use

Replacement therapy for Fabry disease.

Pregnancy and lactiation implications

The benefits versus risks should be considered before initiating therapy in pregnant women. Use with caution during lactation.

Unlabeled use


Hypersensitivity to agalsidase alpha or any component of the formulation. Concomitant use with chloroquine, amiodarone, monobenzone, or gentamicin (might inhibit intracellular agalsidase alpha activity).

Warnings and precautions

Patients may develop IgG antibody formation. Mild acute reactions (chills, facial flushing) are common. Severe reactions (nausea, pyrexia, rigor, tachycardia, urticaria, vomiting) are rare.



Legal Notice
Privacy Policy
Cookie Policy


Phone: +34-981-780505
Location: Sta Marta de, C. P. Babío, S/N, 15165 Bergondo, A Coruña

Copyright © 2023 WAGEM

Add to cart