APO-Dutasteride

What it is

APO-Dutasteride is a dutasteride 500 microgram soft capsule . Dutasteride is a dual 5α-reductase inhibitor that inhibits both type 1 and type 2 5α-reductase isoenzymes, which are responsible for the conversion of testosterone to 5α-dihydrotestosterone (DHT) .

Approved indications

— Management of moderate to severe symptomatic benign prostatic hyperplasia (BPH) .

Dosing overview

The recommended dose of dutasteride is one capsule of 500 micrograms taken orally approximately 30 minutes after the same meal each day . The dose applies to adult males including elderly patients . The capsules should be swallowed whole and not chewed or opened .

Key safety warnings

In the REDUCE study of over 8,000 men aged 50 to 75 with a prior negative biopsy for prostate cancer, there was a higher incidence of Gleason 8 to 10 prostate cancers in the dutasteride group (0.9%) compared to the placebo group (0.6%) . No causal relationship between dutasteride and high grade prostate cancer has been established . Men taking dutasteride should be regularly evaluated for prostate cancer risk including PSA testing . Dutasteride causes a decrease in mean serum PSA levels by approximately 50% after 6 months of treatment, and patients should have a new PSA baseline established after 6 months of treatment . Orthostatic hypotension can occur in patients treated with alpha-adrenergic blockers, and patients should be informed about the possible occurrence of symptoms related to orthostatic hypotension such as dizziness, and should be cautioned to sit or lie down at the first signs of dizziness and vertigo until symptoms have resolved . There have been reports of male breast cancer in men taking dutasteride; however, epidemiological studies showed no statistically significant increase in the risk of developing male breast cancer with the use of 5-ARIs . Prescribers should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge . Men being treated with dutasteride should not donate blood until at least 6 months have passed following their last dose, as the purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient .

Contraindications

APO-Dutasteride is contraindicated in patients with known hypersensitivity to dutasteride, other 5α-reductase inhibitors, or any component of the preparation . It is contraindicated in women and children . APO-Dutasteride is contraindicated in patients with severe renal impairment (creatinine clearance less than 10 mL/min) . It is contraindicated in patients with severe hepatic impairment (Child-Pugh scores greater than 9) .

PBS listing

The 500 microgram capsule strength is listed on the PBS with authority required restriction, with an ex-manufacturer price of A$15.22 .

Regulatory history

APO-Dutasteride (dutasteride 500 microgram soft capsule) was first registered on the ARTG on 28 February 2014 .