Abbreviations
Abbreviations 1,25(OH)2D: 1,25-dihydroxyvitamin D 25(OH)D: 25-hydroxyvitamin D 6MWT: 6-minute walk test AE: adverse event ALP: alkaline phosphatase BALP: bone-specific alkaline phosphatase BFI: brief fatigue inventory BLA: biologics license application BPI: brief pain inventory CI: confidence interval CMA: conditional marketing authorisation CTx: carboxy-terminal cross-linked telopeptide of type 1 collagen ECG: electrocardiogram ECHO: echocardiogram EMA: European Medicines Agency FDA: Food and Drug Administration FGF23: fibroblast growth factor 23 GEE: generalised estimating equation GLMM: generalised linear mixed […]
Starting CRYSVITA
Start treatment with CRYSVITA® as early as possible after diagnosis of XLH in suitable patients Table of Contents As of 10 September 2021, CRYSVITA® has been approved by Therapeutic Goods Administration (TGA) for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents and children 1 year of age or older.1 Full prescibing information can be […]
Pediatric Studies
Treatment with CRYSVITA® in children with XLH demonstrated significant improvement in serum phosphate levels, rickets severity and mobility¹⁻³ Table of Contents Phase II efficacy and safety Efficacy and safety of CRYSVITA® in children aged 1 to 4 years with XLH has been investigated in a phase II study2 Study design2 An open-label, phase II trial […]
Adult Studies
Treatment with CRYSVITA® in adults with XLH demonstrated significant improvement in phosphate levels, measures of osteomalacia, pain, stiffness and mobility1,3 Table of Contents Phase III efficacy and safety Efficacy and safety of CRYSVITA® in adults with XLH have been investigated in a phase III study1,2 Study design1,2 A randomised, double-blind, placebo-controlled, phase III trial was […]
Why CRYSVITA
Treatment with CRYSVITA® restores phosphate homeostasis in adults and children with XLH leading to clinically meaningful improvements¹⁻⁶ Paediatric Studies Adult Studies As of 10 September 2021, CRYSVITA® has been approved by Therapeutic Goods Administration (TGA) for the treatment of X-linked hypophosphataemia (XLH) in adults, adolescents and children 1 year of age or older.8 As of […]
How does CRYSVITA work?
CRYSVITA® (burosumab) is the first and only disease-modifying biologic treatment that targets the pathophysiology of XLH¹ Table of Contents FGF23 and XLH CRYSVITA® is a fully human monoclonal antibody (IgG1) that binds to and inhibits excess FGF23 activity1 Excess levels of FGF23 in XLH lead to:2 Decreased renal phosphate reabsorption, which increases urinary phosphate excretion […]
What is XLH?
XLH is a rare, genetic progressive and life-long phosphate wasting disorder, caused by mutations in the PHEX gene that leads to excess FGF23¹⁻⁴ Causes of XLH XLH is characterised by chronic hypophosphataemia due to increased FGF23 levels2,4 Phosphate is critical to many biological functions.5 Disruption of normal phosphate homeostasis is associated with severe complications and […]
Australia Home
Welcome to the CRYSVITA® work? CRYSVITA® is a recombinant human monoclonal IgG1 antibody that binds to and inhibits the biological activity of fibroblast growth factor 23 (FGF23), present in excess in X-linked hypophosphataemia. Neutralisation of FGF23 by CRYSVITA® increases renal tubular reabsorption of phosphate and the serum concentration of 1, 25 dihydroxy-Vitamin D. 1 Find out […]
Contact us
Kyowa Kirin Australia Pty Ltd / Contact Us Company Contact Details: Kyowa Kirin Australia Pty Ltd 68 York StreetSydneyNSW 2000, AustraliaE-mail: Website: www.kyowakirin.com/australia/ Report Adverse Events and Patient Safety Matters:Australian regulations require that matters potentially impacting patient safety, including suspected adverse events, side effects and pregnancy exposure to Kyowa Lirin’s medicines are documented and reported. […]
Resources
Australian Resources Table of Contents Downloadable materials Crysvita® Resources Australian Product Information for Crysvita® (Burosumab) approved 10 September 2021 Crysvita (Burosumab) Consumer Medicine Information Crysvita (Burosumab) Dosing & Administration Guide Crysvita (Burosumab) Injection Guide Crysvita (Burosumab) HCP Prescribing Guide Crysvita (Burosumab) Dispensing Guide for Patients and Pharmacists Crysvita (Burosumab) Starter guide for adults Crysvita (Burosumab) […]
