APO-FINASTERIDE

What it is

APO-Finasteride 5 is a film-coated tablet containing finasteride 5 mg. The tablets are blue, round and biconvex, marked 'F5' on one side and plain on the other. 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 elderly patients although 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, since the beneficial response to APO-Finasteride 5 may not be manifested immediately. APO-Finasteride 5 may not reduce inconvenience to patients arising from benign prostatic hyperplasia symptoms in patients with mild to moderate enlargement in prostate (less than 40 mL size). 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. 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. 3.7% of patients treated with finasteride discontinued therapy as a result of adverse effects related to sexual function, which were the most frequently reported adverse effects.

Contraindications

APO-Finasteride 5 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. APO-Finasteride 5 is not indicated for use in women or children. Because of the ability of Type II 5a-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. Crushed or broken tablets of APO-Finasteride 5 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.

Regulatory history

APO-Finasteride 5 (ARTG 155238) was first listed on 26 March 2010. In the 7-year Prostate Cancer Prevention Trial (PCPT), men aged 55 and over taking finasteride 5 mg/day had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%).