FINASTA

What it is

FINASTA is a finasteride film-coated tablet available in 5 mg and 1 mg strengths. Finasteride is the active ingredient. Finasteride is a synthetic 4-azasteroid compound and a specific inhibitor of Type II 5a-reductase, an intracellular enzyme which metabolises testosterone into the more potent androgen dihydrotestosterone (DHT).

Approved indications —

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 (creatinine clearances as low as 9 mL/min). No adjustment in dosage is required in the elderly although pharmacokinetic studies indicated the elimination of finasteride is somewhat decreased in patients more than 70 years of age.

Key safety warnings

Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy, as the beneficial response to FINASTA may not be manifested immediately. FINASTA may not reduce inconvenience to patients arising from benign prostatic hyperplasia symptoms in patients with mild to moderate enlargement in prostate (< 40 mL size). Men aged 55 and over with a normal digital rectal examination and PSA ≤ 3.0 ng/mL at baseline taking finasteride 5 mg/day had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). 5a-reductase inhibitors may increase the risk of development of high-grade prostate cancer. 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. 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. Sexual dysfunction was the most frequently reported adverse effect, with 3.7% (57 patients) treated with finasteride and 2.1% (32 patients) treated with placebo discontinuing therapy as a result of adverse effects related to sexual function. Post-marketing experience has reported depression; decreased libido that continued after discontinuation of treatment; suicidal ideation; and sexual dysfunction (erectile dysfunction and ejaculation disorders) that continued after discontinuation of treatment.

Contraindications

FINASTA is contraindicated in use in women when they are or may potentially be pregnant, and in cases of hypersensitivity to any component of this product. FINASTA is not indicated for use in women or children.

Regulatory history

FINASTA 5 mg film-coated tablets were first listed on the ARTG on 4 May 2020, and FINASTA 1 mg film-coated tablets were also first listed on the same date.