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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ENDOCRINE THERAPY › HORMONE ANTAGONISTS AND RELATED AGENTS › Anti-androgens
darolutamide
L02BB06
Forms & Strengths
- Film-coated tablets: 300mg
- Available in bottles of 30, 60, 90 and 120 tablets
Adult Dosing
- Non-metastatic castration-resistant prostate cancer (nmCRPC): 600mg twice daily
- Metastatic hormone-sensitive prostate cancer (mHSPC): 600mg twice daily
Pediatric Dosing
- Not indicated for use in pediatric patients
- Safety and efficacy not established in patients under 18 years
Indications
- Treatment of non-metastatic castration-resistant prostate cancer (nmCRPC)
- Treatment of metastatic hormone-sensitive prostate cancer (mHSPC)
Mechanism of Action
- Androgen receptor inhibitor
- Blocks the effects of androgens by inhibiting androgen binding to the androgen receptor
Contraindications
- Hypersensitivity to darolutamide or any of its components
- Pregnancy: may cause fetal harm
Adverse Reactions
- Fatigue
- Skin rash
- Pruritus
- Diarrhea
- Hot flush
- Hematologic toxicity
Drug Interactions
- Concomitant use with CYP3A4 and P-gp substrates may require dosage adjustment
- Avoid concomitant use with strong CYP3A4 inducers
- Concomitant use with breast cancer resistance protein (BCRP) substrates may require dosage adjustment
Curated Content: Needs Vetting Before Put to Clinical Use