Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Crysvita

CRYSVITA 10 mg solution for injection CRYSVITA 20 mg solution for injection CRYSVITA 30 mg solution for injection CRYSVITA 10 mg solution for injection in pre-filled syringe CRYSVITA 20 mg solution for injection in pre-filled syringe CRYSVITA 30 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 14

HOS-137516 · Präparat HOS-098051

Hyperphosphataemia Adult patients with XLH or TIO: In XLH patients, in the placebo-controlled treatment period of Study UX023-CL303 in the burosumab group, 9 subjects (13.2%) had high serum phosphate at least once; 5 of these 9 required protocol- specified dose reduction(s). After initiation of burosumab in the open-label Treatment Continuation Period, 8 subjects (12.1%) in the placebo→burosumab group had high serum phosphate levels. Four of these 8 subjects required protocol-specified dose reduction(s). The dose for all patients meeting the protocol-specified criteria was reduced by 50%. A single patient (1%) required a second dose reduction for continued hyperphosphataemia. In patients with TIO, based on data from completed long term clinical studies, 11% of patients experienced events of hyperphosphataemia, which were managed with dose reduction.

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