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NUBEQA Label.pdf

212099Orig1s000lbl.pdf
Preview of NUBEQA Label
🔗 Source: accessdata.fda.gov
📊 Size: 902 KB
👤 Author: FDA
⬇️ Downloads: 96

Summary

NUBEQA (darolutamide) is indicated for non-metastatic castration-resistant prostate cancer treatment, with a recommended dose of 600 mg (two 300 mg tablets) taken orally twice daily, and should be taken with food. Patients should also receive a gonadotropin-releasing hormone (GnRH) analog or have had bilateral orchiectomy. Common adverse reactions include fatigue, pain in extremity, and rash. Contraindications and warnings include embryo-fetal toxicity, and interactions with P-gp, CYP3A, and BCRP substrates. Dosage modifications are recommended for patients with severe renal or moderate hepatic impairment.

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Description

NUBEQA (darolutamide) is indicated for non-metastatic castration-resistant prostate cancer treatment, with a recommended dose of 600 mg (two 300 mg tablets)...

Technical Information

  • File Format: PDF
  • File Size: 902 KB
  • Pages: 15
  • Language: EN
  • Author: FDA
  • Total Downloads: 96
  • Last Updated: 3 weeks ago

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This PDF document about NUBEQA Label provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into NUBEQA Label.

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