Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Stoboclo

Stoboclo 60 mg solution for injection in pre-filled syringe · Abschnitt 4.8 · PDF-Seite 7

HOS-151773 · Präparat HOS-100617

In the post-marketing setting, rare cases of severe symptomatic hypocalcaemia resulting in hospitalisation, life-threatening events, and fatal cases have been reported, predominantly in patients at increased risk of hypocalcaemia receiving denosumab, with most cases occurring in the first weeks of initiating therapy. Examples of the clinical manifestations of severe symptomatic hypocalcaemia have included QT interval prolongation, tetany, seizures and altered mental status (see section 4.4). Symptoms of hypocalcaemia in denosumab clinical studies included paraesthesias or muscle stiffness, twitching, spasms and muscle cramps.

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