Dutasteride
Regulatory sources consulted
- aemps-cima-ft-65178
- RxNorm rxcui 228790 ↗
Approved indications
- Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
- Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.
Contraindications
Absolute
- Women, children and adolescents.
- Hypersensitivity to dutasteride, other 5-alpha-reductase inhibitors, or to any of the excipients.
- Severe hepatic impairment.
Clinical warnings
- Major warning · Prostate cancer and high-grade tumors: In the REDUCE study, a higher incidence of Gleason score 8-10 prostate cancers was observed in men treated with dutasteride compared to placebo. — AEMPS SPC
- Heart failure: The incidence of heart failure was higher in subjects taking the combination of dutasteride and an alpha-blocker, mainly tamsulosin, than in subjects not taking the combination. — AEMPS SPC
Drug interactions
- HighRitonavirJ05AE03
Mechanism: Potent inhibition of CYP3A4, the main metabolic pathway for dutasteride, which can significantly increase dutasteride serum concentrations.
Recommendation: Combination with potent CYP3A4 inhibitors like ritonavir is not recommended. If necessary, the patient should be closely monitored for adverse effects.
AEMPS SPC
Adverse events
Common (≥1%)
impotence · decreased libido · ejaculation disorders · gynecomastia
Rare but serious
angioedema · heart failure · high-grade prostate cancer
Pregnancy and lactation
FDA category: X
Contraindicated in women. Risk of abnormalities to the external genitalia of a male foetus. Women who are pregnant or may be fertile should not handle leaking capsules because of the possibility of absorption of dutasteride through the skin.