FINASTERIDE-WGR

What it is

FINASTERIDE-WGR contains finasteride 5 mg as film-coated tablets. Finasteride is a synthetic 4-azasteroid compound and a specific inhibitor of Type II 5α-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen dihydrotestosterone (DHT).

Approved indications

— Treatment of patients with symptomatic benign prostatic hyperplasia (BPH) with an enlarged prostate.

Dosing overview

The recommended dosage is one 5 mg tablet daily with or without food. Adjustments in dosage are not necessary in patients with varying degrees of renal insufficiency. No adjustment in dosage is required in the elderly.

Key safety warnings

Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. FINASTERIDE-WGR may not reduce inconvenience to patients arising from benign prostatic hyperplasia symptoms in patients with mild to moderate enlargement in prostate (< 40 mL size). Digital rectal examinations, as well as other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with finasteride and periodically thereafter. Finasteride causes a decrease in serum PSA levels by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease in serum PSA levels should be considered when evaluating PSA laboratory data and does not rule out concomitant prostate cancer. Men aged 55 and over with a normal digital rectal examination and PSA ≤ 3.0 ng/mL at baseline taking finasteride 5 mg/day in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Sexual dysfunction was the most frequently reported adverse effect, with 3.7% of patients treated with finasteride and 2.1% treated with placebo discontinuing therapy as a result of adverse effects related to sexual function.

Contraindications

FINASTERIDE-WGR is contraindicated in use in women when they are or may potentially be pregnant and in patients with hypersensitivity to any component of this product. It is not indicated for use in women or children. Because of the ability of Type II 5α-reductase inhibitors to inhibit conversion of testosterone to dihydrotestosterone, finasteride may cause abnormalities of the external genitalia of a male foetus when administered to a pregnant woman.

Regulatory history

FINASTERIDE-WGR finasteride 5 mg film-coated tablet blister pack was first listed on the ARTG on 13 August 2024.