1 INDICATIONS AND USAGE Finasteride, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to : • Improve symptoms • Reduce the risk of acute urinary retention • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score) .

Limitations of Use: Finasteride tablets are not approved for the prevention of prostate cancer .

1.1 Monotherapy Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to: - Improve symptoms - Reduce the risk of acute urinary retention - Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

1.2 Combination with Alpha-Blocker Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥4 point increase in American Urological Association (AUA) symptom score).

1.3 Limitations of Use Finasteride tablets are not approved for the prevention of prostate cancer.

6 ADVERSE REACTIONS ‑ The drug-related adverse reactions, reported in ≥1% in patients treated with finasteride and greater than in patients treated with placebo over a 4-year study are: impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness and rash .

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc.

at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

4-Year Placebo-Controlled Study (A Long-Term Efficacy and Safety Study) In a long-term efficacy and safety study, 1524 patients treated with finasteride and 1516 patients treated with placebo were evaluated for safety over a period of 4 years.

The most frequently reported adverse reactions were related to sexual function.

3.7% (57 patients) treated with finasteride and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to sexual function, which are the most frequently reported adverse reactions.

Table 1 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on finasteride was ≥1% and greater than placebo over the 4 years of the study.

In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

Table 1: Drug-Related Adverse Experiences Year 1 (%) Years 2, 3 and 4* (%) Finasteride Placebo Finasteride Placebo * Combined Years 2 to 4 N = 1524 and 1516, finasteride vs.

placebo, respectively Impotence 8.1 3.7 5.1 5.1 Decreased Libido 6.4 3.4 2.6 2.6 Decreased Volume of Ejaculate 3.7 0.8 1.5 0.5 Ejaculation Disorder 0.8 0.1 0.2 0.1 Breast Enlargement 0.5 0.1 1.8 1.1 Breast Tenderness 0.4 0.1 0.7 0.3 Rash 0.5 0.2 0.5 0.1 Phase III Studies and 5-Year Open Extensions The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and a long-term efficacy and safety study were similar.

Medical Therapy of Prostatic Symptoms (MTOPS) Study In the MTOPS study, 3047 men with symptomatic BPH were randomized to receive finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737) for 4 to 6 years.

[See .] The incidence rates of drug-related adverse experiences reported by ≥2% of patients in any treatment group in the MTOPS Study are listed in Table 2.

The individual adverse effects which occurred more frequently in the combination group compared to either drug alone were: asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 2).

Of these, the incidence of abnormal ejaculation in patients receiving combination therapy was comparable to the sum of the incidences of this adverse experience reported for the two monotherapies.

Combination therapy with finasteride and doxazosin was associated with no new clinical adverse experience.

Four patients in MTOPS reported the adverse experience breast cancer.

Three of these patients were on finasteride only and one was on combination therapy.

[See Long-Term Data.] The MTOPS Study was not specifically designed to make statistical comparisons between groups for reported adverse experiences.

In addition, direct comparisons of safety data between the MTOPS study and previous studies of the single agents may not be appropriate based upon differences in patient population, dosage or dose regimen, and other procedural and study design elements.

Table 2: Incidence ≥2% in One or More Treatment Groups Drug-Related Clinical Adverse Experiences in MTOPS Adverse Experience Placebo (N=737) (%) Doxazosin 4 mg or 8 mg* (N=756) (%) Finasteride (N=768) (%) Combination (N=786) (%) * Doxazosin dose was achieved by weekly titration (1 to 2 to 4 to 8 mg).

The final tolerated dose (4 mg or 8 mg) was administered at end-Week 4.

Only those patients tolerating at least 4 mg were kept on doxazosin.

The majority of patients received the 8 mg dose over the duration of the study.

Body as a whole Asthenia Headache 7.1 2.3 15.7 4.1 5.3 2 16.8 2.3 Cardiovascular Hypotension Postural Hypotension 0.7 8 3.4 16.7 1.2 9.1 1.5 17.8 Metabolic and Nutritional Peripheral Edema 0.9 2.6 1.3 3.3 Nervous Dizziness Libido Decreased Somnolence 8.1 5.7 1.5 17.7 7 3.7 7.4 10 1.7 23.2 11.6 3.1 Respiratory Dyspnea Rhinitis 0.7 0.5 2.1 1.3 0.7 1 1.9 2.4 Urogenital Abnormal Ejaculation Gynecomastia Impotence Sexual Function Abnormal 2.3 0.7 12.2 0.9 4.5 1.1 14.4 2 7.2 2.2 18.5 2.5 14.1 1.5 22.6 3.1 Long-Term Data High-Grade Prostate Cancer The PCPT trial was a 7-year randomized, double-blind, placebo-controlled trial that enrolled 18,882 men ≥55 years of age with a normal digital rectal examination and a PSA ≤3 ng/mL.

Men received either finasteride 5 mg or placebo daily.

Patients were evaluated annually with PSA and digital rectal exams.

Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study.

The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%) [see and ].

In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART), similar results for Gleason score 8 to 10 prostate cancer were observed (1% dutasteride vs.

0.5% placebo).

No clinical benefit has been demonstrated in patients with prostate cancer treated with finasteride.

Breast Cancer During the 4- to 6-year placebo- and comparator-controlled MTOPS study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride but no cases in men not treated with finasteride.

During the 4-year, placebo-controlled a long-term efficacy and safety study that enrolled 3040 men, there were 2 cases of breast cancer in placebo-treated men but no cases in men treated with finasteride.

During the 7-‑year placebo-controlled Prostate Cancer Prevention Trial (PCPT) that enrolled 18,882 men, there was 1 case of breast cancer in men treated with finasteride, and 1 case of breast cancer in men treated with placebo.

The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

Sexual Function There is no evidence of increased sexual adverse experiences with increased duration of treatment with finasteride.

New reports of drug-related sexual adverse experiences decreased with duration of therapy.

6.2 Postmarketing Experience The following additional adverse events have been reported in postmarketing experience with finasteride.

Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: - hypersensitivity reactions, such as pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face) - testicular pain - hematospermia - sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, decreased libido and ejaculation disorders (e.g., reduced ejaculate volume).

These events were reported rarely in men taking finasteride for the treatment of BPH.

Most men were older and were taking concomitant medications and/or had co-morbid conditions.

The independent role of finasteride in these events is unknown.

- male infertility and/or poor seminal quality were reported rarely in men taking finasteride for the treatment of BPH.

Normalization or improvement of poor seminal quality has been reported after discontinuation of finasteride.

The independent role of finasteride in these events is unknown.

- depression - male breast cancer.

The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with finasteride at lower doses used to treat male pattern baldness.

Because the event is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure: - orgasm disorders