Nubeqa 300mg FC tablets

Nubeqa 300mg FC tablets

S4
PDF Leaflet Revision Date: 6 December 2024

API: Darolutamide | Company: Bayer

Clinical Summary

Quick overview from the medicine insert

Indication

Treatment of non-metastatic castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer.

Dosage (summary)

600 mg (two 300 mg tablets) twice daily.

Special Populations

  • Elderly
  • Renal impairment
  • Hepatic impairment

Pregnancy & Breastfeeding

Not indicated for women who are or may become pregnant; potential for fetal harm.

Key Drug Interactions

  • Strong CYP3A4 and P-gp inducers
  • Rosuvastatin

Contraindications

  • Hypersensitivity to darolutamide or excipients
  • Pregnant women

Common side effects

  • Fatigue
  • Rash
  • Hypertension

Counselling Points

  • Take with food
  • Use effective contraception during treatment

Serious warnings

  • Monitor for renal and hepatic impairment
  • Risk of QT prolongation
Important Disclaimer

The Nubeqa 300mg FC tablets professional information leaflet below is the property of Bayer and is provided on Medinsert exactly as issued, with no.. alterations or editorial changes. We make every effort to keep content current by updating documents as soon as new versions become available. Medinsert serves as a trusted access point for healthcare professionals, but does not replace official sources or clinical judgement. For more details, please read our full disclaimer. read more>>

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