Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Aclasta

Aclasta 5 mg solution for infusion · Abschnitt 4.8 · PDF-Seite 7–8

HOS-113818 · Präparat HOS-093969

7  Musculoskeletal and connective tissue Common Myalgia, arthralgia, bone pain, back disorders pain, pain in extremity Uncommon Neck pain, musculoskeletal stiffness, joint swelling, muscle spasms, musculoskeletal chest pain, musculoskeletal pain, joint stiffness, arthritis, muscular weakness Rare Atypical subtrochanteric and diaphyseal femoral fractures† (bisphosphonate class adverse reaction) Very rare Osteonecrosis of the external auditory canal (bisphosphonate class adverse reaction) Not known** Osteonecrosis of the jaw (see sections 4.4 and 4.8 Class effects) Renal and urinary disorders Uncommon Blood creatinine increased, pollakiuria, proteinuria Not known** Renal impairment. Rare cases of renal failure requiring dialysis and rare cases with a fatal outcome have been reported in patients with pre-existing renal dysfunction or other risk factors such as advanced age, concomitant nephrotoxic medicinal products, concomitant diuretic therapy, or dehydration in the post infusion period (see sections 4.4 and 4.8 Class effects) General disorders and administration Very common Pyrexia site conditions Common Influenza-like illness, chills, fatigue, asthenia, pain, malaise, infusion site reaction Uncommon Peripheral oedema, thirst, acute phase reaction, non-cardiac chest pain Not known** Dehydration secondary to acute phase reactions (post-dose symptoms such as pyrexia, vomiting and diarrhoea) Investigations Common C-reactive protein increased Uncommon Blood calcium decreased # Observed in patients taking concomitant glucocorticosteroids. * Common in Paget’s disease only. ** Based on post-marketing reports. Frequency cannot be estimated from available data. † Identified in post-marketing experience.

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