Dutasteride

Class
Antiandrogens
Subclass
5α-reductase inhibitors
Substance name
Dutasteride
Brand names
Avodart®
Common formulations
Capsule
Dosage and administration
Adults patients
BPH
0.5 mg PO daily
Androgenetic alopeciaOff-label
0.5 mg PO daily
Indications for use
Labeled indications
Adults
Treatment of BPH
Off-label indications
Adults
Treatment of androgenetic alopecia
Safety risks
Contraindications
Hypersensitivity to dutasteride or its components or other 5-α-reductase inhibitors
Pregnancy
Do not allow patients taking dutasteride to donate blood until at least 6 months after the last dose in order to prevent the administration of dutasteride to pregnant transfusion recipients.
Warnings and precautions
Decreased serum PSA
Maintain a high level of suspicion, as dutasteride reduces serum PSA levels even in the presence of prostate cancer. Measure baseline PSA at least 3 months after initiating dutasteride and monitor periodically thereafter. Evaluate for prostate cancer in case of any increase from the lowest PSA level, even if the values are still within the normal range.
High-grade prostate cancer
Maintain a high level of suspicion, as an increased incidence has been reported in patients receiving dutasteride. Assess for other urological conditions that may cause similar symptoms before initiating dutasteride, recognizing that BPH and prostate cancer may coexist.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
Use acceptable. No dose adjustment required.
Hepatic impairment
Any severity
No dose adjustment required. Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: X
Do not use. Evidence of fetal harm in humans. Ensure females who are pregnant or may be pregnant do not handle dutasteride capsule.
Breastfeeding
Do not use during breastfeeding.
Adverse reactions
Very common > 10%
Erectile dysfunction
Common 1-10%
Gynecomastia, anejaculation, breast pain, breast tenderness, ↓ libido, dizziness
Uncommon < 1%
Heart failure
Unknown frequency
Angioedema, ↑ serum testosterone, testicular pain, testicular swelling, male breast cancer, prostate cancer, oligozoospermia, pruritus, skin rash, urticaria
Interactions
Drug(s)
Check Interactions
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