Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Zoledronic acid Mylan

Zoledronic acid Mylan 4 mg/5 ml concentrate for solution for infusion · Abschnitt 4.8 · PDF-Seite 10

HOS-126259 · Präparat HOS-096231

Description of selected adverse reactions Renal function impairment Zoledronic acid has been associated with reports of renal dysfunction. In a pooled analysis of safety data from zoledronic acid registration trials for the prevention of skeletal-related events in patients with advanced malignancies involving bone, the frequency of renal impairment adverse events suspected to be related to zoledronic acid (adverse reactions) was as follows: multiple myeloma (3.2%), prostate cancer (3.1%), breast cancer (4.3%), lung and other solid tumours (3.2%). Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of zoledronic acid or other bisphosphonates, as well as concomitant use of nephrotoxic medicinal products or using a shorter infusion time than currently recommended. Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of 4 mg zoledronic acid (see section 4.4).

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