PROSCAR

What it is

PROSCAR contains finasteride 5 mg film-coated tablets. 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

— 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 elderly patients although the elimination of finasteride is somewhat decreased in patients more than 70 years of age.

Key safety warnings

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%). 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. 3.7% of patients treated with finasteride and 2.1% treated with placebo discontinued therapy as a result of adverse effects related to sexual function, which were the most frequently reported adverse effects. Post-marketing experience has included reports of depression, decreased libido that continued after discontinuation of treatment, suicidal ideation, sexual dysfunction that continued after discontinuation of treatment, breast tenderness and enlargement, male breast cancer, and testicular pain.

Contraindications

PROSCAR 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. Crushed or broken tablets should not be handled by women when they are or may potentially be pregnant because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus.

PBS listing

PROSCAR 5 mg tablets are listed on the PBS with 2 items, authority required restriction, at an ex-manufacturer price of A$80.91.

Regulatory history

PROSCAR finasteride 5 mg tablet was first registered on the ARTG on 26 October 1993.