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1 Indications And Usage Elaprase Is Indicated For Patients With Hunter Syndrome (Mucopolysaccharidosis Ii, Mps Ii). Elaprase Has Been Shown To Improve Walking Capacity In Patients 5 Years And Older. In Patients 16 Months To 5 Years Of Age, No Data Are Available To Demonstrate Improvement In Disease-Related Symptoms Or Long Term Clinical Outcome; However, Treatment With Elaprase Has Reduced Spleen Volume Similarly To That Of Adults And Children 5 Years Of Age And Older. The Safety And Efficacy Of Elaprase Have Not Been Established In Pediatric Patients Less Than 16 Months Of Age [See Use In Specific Populations (8.4) ]. Elaprase Is A Hydrolytic Lysosomal Glycosaminoglycan (Gag)-Specific Enzyme Indicated For Patients With Hunter Syndrome (Mucopolysaccharidosis Ii, Mps Ii). Elaprase Has Been Shown To Improve Walking Capacity In Patients 5 Years And Older. In Patients 16 Months To 5 Years Of Age, No Data Are Available To Demonstrate Improvement In Disease-Related Symptoms Or Long Term Clinical Outcome; However, Treatment With Elaprase Has Reduced Spleen Volume Similarly To That Of Adults And Children 5 Years Of Age And Older. The Safety And Efficacy Of Elaprase Have Not Been Established In Pediatric Patients Less Than 16 Months Of Age ( 1 ).
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