Comparative Pharmacology
Head-to-head clinical analysis: ELAPRASE versus FABRAZYME.
Peer-Reviewed Evidence
Head-to-head clinical analysis: ELAPRASE versus FABRAZYME.
ELAPRASE vs FABRAZYME
Comparing the clinical profiles, pharmacokinetic behaviors, and safety indices of these two therapeutic agents.
Idursulfase is a recombinant form of iduronate-2-sulfatase, the enzyme deficient in Hunter syndrome (MPS II). It hydrolyzes 2-sulfate groups from the terminal iduronate sulfate glycosaminoglycans (GAGs) dermatan sulfate and heparan sulfate, thereby reducing GAG accumulation in tissues.
Fabrazyme (agalsidase beta) is a recombinant human alpha-galactosidase A enzyme that hydrolyzes globotriaosylceramide (Gb3) and other glycosphingolipids with terminal alpha-galactosyl residues, thereby reducing accumulation of these substrates in tissues.
0.58 mg/kg IV once weekly administered over 1 hour
1 mg/kg intravenously every 2 weeks infused over 4-6 hours.
None Documented
None Documented
Terminal half-life: 6.5–8.5 hours (mean 7.5 h) in pediatric patients; supports weekly IV dosing
Terminal elimination half-life ranges from 80 to 120 minutes (1.3-2 hours) in adults, which supports a bi-weekly intravenous dosing regimen.
Renal: negligible; primarily catabolized via peptide hydrolysis to amino acids, which are reused or excreted
Primarily eliminated via renal pathways; 55-65% of the administered dose is recovered in urine as unchanged drug, with less than 5% recovered in feces.
Category C
Category C
Enzyme Replacement Therapy
Enzyme Replacement Therapy