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Anti-RANKLInjection sous-cutanée semestrielleAmgen

Prolia® / Xgeva®

DCI : Denosumab

Anticorps monoclonal anti-RANKL. 60 mg SC tous les 6 mois. Effet rebond à l'arrêt → relais bisphosphonate obligatoire.

Pharmacovigilance — Top effets indésirables

16 239 rapports FAERS
  • OSTEONECROSIS OF JAW1 535 (13%)
  • Diarrhée1 157 (9%)
  • Fatigue1 125 (9%)
  • Nausées1 082 (9%)
  • MALIGNANT NEOPLASM PROGRESSION1 053 (9%)
  • NEUTROPENIA935 (8%)
  • METASTASES TO BONE837 (7%)
  • Utilisation hors AMM824 (7%)
  • ANAEMIA755 (6%)
  • VOMITING623 (5%)
  • DECREASED APPETITE601 (5%)
  • Dyspnée599 (5%)
  • HYPOCALCAEMIA579 (5%)
  • Inefficacité du traitement533 (4%)

Source : OpenFDA / FAERS (FDA Adverse Event Reporting System). Termes MedDRA traduits FR. Les rapports incluent des attributions causales non confirmées.

⚠️ Rappels (recalls) FDA

  • D-66318-001

    Class II

    Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.

    20130917 · Terminated

  • D-0538-2025

    Class II

    CGMP Deviations; potential temperature excursions due to transit delays

    20250421 · Ongoing

Avis HAS — Commission de la Transparence

Source HAS via Google News RSS · avis SMR/ASMR officiels.

Avis HAS CNEDiMTS — Dispositifs / Numérique

Ressources patient & prescripteur

Sources : OpenFDA (FAERS), HAS Commission de la Transparence, base ANSM. Ne se substitue pas au RCP.