Finasteride

Regulatory sources consulted

• AEMPS CIMA SPC: 67857
• https://cima.aemps.es/cima/dochtml/ft/67857/FT_67857.html
• Professional knowledge base
• AEMPS CIMA · nº registro 67857 ↗
• RxNorm rxcui 25025 ↗

Approved indications

• Treatment and control of benign prostatic hyperplasia (BPH) to cause regression of the enlarged prostate, improve urinary flow and improve symptoms associated with BPH.
• Treatment of male pattern hair loss (androgenetic alopecia) in men (1 mg/day dose). Use of the 5 mg dose for this indication is off-label. · off-label

Contraindications

Clinical warnings

• Major warning · Finasteride reduces serum PSA concentrations, which should be considered when evaluating PSA levels for prostate cancer detection. — AEMPS SPC
• Major warning · Male breast cancer has been reported. Patients should be instructed to report any changes in their breast tissue. — AEMPS SPC
• Mood alterations, including depressed mood, depression and, less frequently, suicidal ideation have been reported. Patients should be monitored. — AEMPS SPC

Drug interactions

• LowStrong CYP3A4 inhibitors (e.g., itraconazole, ritonavir)J02AC02

  Mechanism: Finasteride is metabolized by CYP3A4. Inhibition of this enzyme may increase finasteride concentrations, although no clinically significant interactions have been identified.

  Recommendation: No dose adjustment is required, but monitoring for adverse effects is advisable if co-administered with potent long-term CYP3A4 inhibitors.

  AEMPS SPC

Adverse events

Pregnancy and lactation

FDA category: X

Contraindicated in women who are or may potentially be pregnant. Women who are pregnant or may become pregnant should not handle crushed or broken finasteride tablets due to the risk of absorption and subsequent risk to a male fetus.