PROSCAR®

(FINASTERIDE)
TABLETS

DESCRIPTION
PROSCAR * (finasteride), a synthetic 4-azasteroid compound, is a specific inhibitor of steroid Type II
5α-reductase, an intracellular enzyme that converts the androgen testosterone into
5α-dihydrotestosterone (DHT).
Finasteride is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17β)-. The
empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:

Finasteride is a white crystalline powder with a melting point near 250°C. It is freely soluble in
chloroform and in lower alcohol solvents, but is practically insoluble in water.
PROSCAR (finasteride) tablets for oral administration are film-coated tablets that contain 5 mg of
finasteride and the following inactive ingredients: hydrous lactose, microcrystalline cellulose,
pregelatinized starch, sodium starch glycolate, hydroxypropyl cellulose LF, hydroxypropyl
methylcellulose, titanium dioxide, magnesium stearate, talc, docusate sodium, FD&C Blue 2 aluminum
lake and yellow iron oxide.

CLINICAL PHARMACOLOGY
The development and enlargement of the prostate gland is dependent on the potent androgen,
5α-dihydrotestosterone (DHT). Type II 5α−reductase metabolizes testosterone to DHT in the prostate
gland, liver and skin. DHT induces androgenic effects by binding to androgen receptors in the cell nuclei
of these organs.
Finasteride is a competitive and specific inhibitor of Type II 5α-reductase with which it slowly forms a
stable enzyme complex. Turnover from this complex is extremely slow (t½ ∼ 30 days). This has been
demonstrated both in vivo and in vitro. Finasteride has no affinity for the androgen receptor. In man, the
5α-reduced steroid metabolites in blood and urine are decreased after administration of finasteride.
In man, a single 5-mg oral dose of PROSCAR produces a rapid reduction in serum DHT
concentration, with the maximum effect observed 8 hours after the first dose. The suppression of DHT is
maintained throughout the 24-hour dosing interval and with continued treatment. Daily dosing of
PROSCAR at 5 mg/day for up to 4 years has been shown to reduce the serum DHT concentration by
approximately 70%. The median circulating level of testosterone increased by approximately 10-20% but
remained within the physiologic range.
Adult males with genetically inherited Type II 5α-reductase deficiency also have decreased levels of
DHT. Except for the associated urogenital defects present at birth, no other clinical abnormalities related

*Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Copyright © 1992, 1995, 1998 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
PROSCAR® (Finasteride) Tablets 9631305

to Type II 5α-reductase deficiency have been observed in these individuals. These individuals have a
small prostate gland throughout life and do not develop BPH.
In patients with BPH treated with finasteride (1-100 mg/day) for 7-10 days prior to prostatectomy, an
approximate 80% lower DHT content was measured in prostatic tissue removed at surgery, compared to
placebo; testosterone tissue concentration was increased up to 10 times over pretreatment levels,
relative to placebo. Intraprostatic content of prostate-specific antigen (PSA) was also decreased.
In healthy male volunteers treated with PROSCAR for 14 days, discontinuation of therapy resulted in
a return of DHT levels to pretreatment levels in approximately 2 weeks. In patients treated for three
months, prostate volume, which declined by approximately 20%, returned to close to baseline value after
approximately three months of discontinuation of therapy.
Pharmacokinetics
Absorption
In a study of 15 healthy young subjects, the mean bioavailability of finasteride 5-mg tablets was 63%
(range 34-108%), based on the ratio of area under the curve (AUC) relative to an intravenous (IV)
reference dose. Maximum finasteride plasma concentration averaged 37 ng/mL (range, 27-49 ng/mL)
and was reached 1-2 hours postdose. Bioavailability of finasteride was not affected by food.
Distribution
Mean steady-state volume of distribution was 76 liters (range, 44-96 liters). Approximately 90% of
circulating finasteride is bound to plasma proteins. There is a slow accumulation phase for finasteride
after multiple dosing. After dosing with 5 mg/day of finasteride for 17 days, plasma concentrations of
finasteride were 47 and 54% higher than after the first dose in men 45-60 years old (n=12) and ≥70 years
old (n=12), respectively. Mean trough concentrations after 17 days of dosing were 6.2 ng/mL (range, 2.4­
9.8 ng/mL) and 8.1 ng/mL (range, 1.8-19.7 ng/mL), respectively, in the two age groups. Although steady
state was not reached in this study, mean trough plasma concentration in another study in patients with
BPH (mean age, 65 years) receiving 5 mg/day was 9.4 ng/mL (range, 7.1-13.3 ng/mL; n=22) after over a
year of dosing.
Finasteride has been shown to cross the blood brain barrier but does not appear to distribute
preferentially to the CSF.
In 2 studies of healthy subjects (n=69) receiving PROSCAR 5 mg/day for 6-24 weeks, finasteride
concentrations in semen ranged from undetectable (<0.1 ng/mL) to 10.54 ng/mL. In an earlier study using
a less sensitive assay, finasteride concentrations in the semen of 16 subjects receiving PROSCAR
5 mg/day ranged from undetectable (<1.0 ng/mL) to 21 ng/mL. Thus, based on a 5-mL ejaculate volume,
the amount of finasteride in semen was estimated to be 50- to 100-fold less than the dose of finasteride
(5 μg) that had no effect on circulating DHT levels in men (see also PRECAUTIONS, Pregnancy).
Metabolism
Finasteride is extensively metabolized in the liver, primarily via the cytochrome P450 3A4 enzyme
subfamily. Two metabolites, the t-butyl side chain monohydroxylated and monocarboxylic acid
metabolites, have been identified that possess no more than 20% of the 5α-reductase inhibitory activity of
finasteride.
Excretion
In healthy young subjects (n=15), mean plasma clearance of finasteride was 165 mL/min (range, 70­
279 mL/min) and mean elimination half-life in plasma was 6 hours (range, 3-16 hours). Following an oral
14
dose of C-finasteride in man (n=6), a mean of 39% (range, 32-46%) of the dose was excreted in the
urine in the form of metabolites; 57% (range, 51-64%) was excreted in the feces.
The mean terminal half-life of finasteride in subjects ≥70 years of age was approximately 8 hours
(range, 6-15 hours; n=12), compared with 6 hours (range, 4-12 hours; n=12) in subjects 45-60 years of
age. As a result, mean AUC(0-24 hr) after 17 days of dosing was 15% higher in subjects ≥70 years of age
than in subjects 45-60 years of age (p=0.02).
Special Populations
Pediatric: Finasteride pharmacokinetics have not been investigated in patients <18 years of age.
Gender: Finasteride pharmacokinetics in women are not available.
Geriatric: No dosage adjustment is necessary in the elderly. Although the elimination rate of finasteride is
decreased in the elderly, these findings are of no clinical significance. (See also Pharmacokinetics,
Excretion, PRECAUTIONS, Geriatric Use and DOSAGE AND ADMINISTRATION.)
Race: The effect of race on finasteride pharmacokinetics has not been studied.
Renal Insufficiency: No dosage adjustment is necessary in patients with renal insufficiency. In patients
with chronic renal impairment, with creatinine clearances ranging from 9.0 to 55 mL/min, AUC, maximum
14
plasma concentration, half-life, and protein binding after a single dose of C-finasteride were similar to
values obtained in healthy volunteers. Urinary excretion of metabolites was decreased in patients with
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PROSCAR® (Finasteride) Tablets 9631305

renal impairment. This decrease was associated with an increase in fecal excretion of metabolites.
Plasma concentrations of metabolites were significantly higher in patients with renal impairment (based
on a 60% increase in total radioactivity AUC). However, finasteride has been well tolerated in BPH
patients with normal renal function receiving up to 80 mg/day for 12 weeks, where exposure of these
patients to metabolites would presumably be much greater.
Hepatic Insufficiency: The effect of hepatic insufficiency on finasteride pharmacokinetics has not been
studied. Caution should be used in the administration of PROSCAR in those patients with liver function
abnormalities, as finasteride is metabolized extensively in the liver.
Drug Interactions (see also PRECAUTIONS, Drug Interactions)
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect
the cytochrome P450-linked drug metabolism enzyme system. Compounds that have been tested in man
have included antipyrine, digoxin, propranolol, theophylline, and warfarin, and no clinically meaningful
interactions were found.

Mean (SD) Pharmacokinetic Parameters

in Healthy Young Subjects (n=15)
Mean (± SD)
Bioavailability 63% (34-108%)*
Clearance (mL/min) 165 (55)
Volume of Distribution (L) 76 (14)
Half-Life (hours) 6.2 (2.1)
*Range

Mean (SD) Noncompartmental Pharmacokinetic Parameters After Multiple Doses of 5

mg/day in Older Men
Mean (± SD)
45-60 years old (n=12) ≥70 years old (n=12)
AUC (ng•hr/mL) 389 (98) 463 (186)
Peak Concentration (ng/mL) 46.2 (8.7) 48.4 (14.7)
Time to Peak (hours) 1.8 (0.7) 1.8 (0.6)
Half-Life (hours)* 6.0 (1.5) 8.2 (2.5)
*First-dose values; all other parameters are last-dose values

Clinical Studies
PROSCAR 5 mg/day was initially evaluated in patients with symptoms of BPH and enlarged prostates
by digital rectal examination in two 1-year, placebo-controlled, randomized, double-blind studies and their
5-year open extensions.
PROSCAR was further evaluated in the PROSCAR Long-Term Efficacy and Safety Study (PLESS), a
double-blind, randomized, placebo-controlled, 4-year, multicenter study. 3040 patients between the ages
of 45 and 78, with moderate to severe symptoms of BPH and an enlarged prostate upon digital rectal
examination, were randomized into the study (1524 to finasteride, 1516 to placebo) and 3016 patients
were evaluable for efficacy. 1883 patients completed the 4-year study (1000 in the finasteride group, 883
in the placebo group).
Effect on Symptom Score
Symptoms were quantified using a score similar to the American Urological Association Symptom
Score, which evaluated both obstructive symptoms (impairment of size and force of stream, sensation of
incomplete bladder emptying, delayed or interrupted urination) and irritative symptoms (nocturia, daytime
frequency, need to strain or push the flow of urine) by rating on a 0 to 5 scale for six symptoms and a 0 to
4 scale for one symptom, for a total possible score of 34.
Patients in PLESS had moderate to severe symptoms at baseline (mean of approximately 15 points
on a 0-34 point scale). Patients randomized to PROSCAR who remained on therapy for 4 years had a
mean (± 1 SD) decrease in symptom score of 3.3 (± 5.8) points compared with 1.3 (± 5.6) points in the
placebo group. (See Figure 1.) A statistically significant improvement in symptom score was evident at
1 year in patients treated with PROSCAR vs placebo (–2.3 vs –1.6), and this improvement continued
through Year 4.

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PROSCAR® (Finasteride) Tablets 9631305

Figure 1
Symptom Score in PLESS
0

-1 Placebo

Mean Change from Baseline ± 1 SE

-2

-3

Finasteride

-4

-5
n = 1438 1296 1101 961 855
n = 1437 1314 1153 1047 965

-6
Baseline Year 1 Year 2 Year 3 Year 4

Results seen in earlier studies were comparable to those seen in PLESS. Although an early
improvement in urinary symptoms was seen in some patients, a therapeutic trial of at least 6 months was
generally necessary to assess whether a beneficial response in symptom relief had been achieved. The
improvement in BPH symptoms was seen during the first year and maintained throughout an additional
5 years of open extension studies.
Effect on Acute Urinary Retention and the Need for Surgery
In PLESS, efficacy was also assessed by evaluating treatment failures. Treatment failure was
prospectively defined as BPH-related urological events or clinical deterioration, lack of improvement
and/or the need for alternative therapy. BPH-related urological events were defined as urological surgical
intervention and acute urinary retention requiring catheterization. Complete event information was
available for 92% of the patients. The following table (Table 1) summarizes the results.

Table 1
All Treatment Failures in PLESS
Patients (%) *

Event Placebo Finasteride Relative 95% CI P

N=1503 N=1513 Risk** Value**
All Treatment Failures 37.1 26.2 0.68 (0.57 to 0.79) <0.001
Surgical 10.1 4.6 0.45 (0.32 to 0.63) <0.001
Interventions for
BPH
Acute Urinary 6.6 2.8 0.43 (0.28 to 0.66) <0.001
Retention
Requiring
Catheterization
Two consecutive 9.2 6.7
symptom scores
≥20
Bladder Stone 0.4 0.5

Incontinence 2.1 1.7

Renal Failure 0.5 0.6

UTI 5.7 4.9

Discontinuation 21.8 13.3

due to worsening
of BPH, lack of
improvement, or
to receive other
medical
treatment
*patients with multiple events may be counted more than once for each type of event

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PROSCAR® (Finasteride) Tablets 9631305

**Hazard ratio based on log rank test

Compared with placebo, PROSCAR was associated with a significantly lower risk for acute urinary
retention or the need for BPH-related surgery [13.2% for placebo vs 6.6% for PROSCAR; 51% reduction
in risk, 95% CI: (34 to 63%)]. Compared with placebo, PROSCAR was associated with a significantly
lower risk for surgery [10.1% for placebo vs 4.6% for PROSCAR; 55% reduction in risk, 95% CI: (37 to
68%)] and with a significantly lower risk of acute urinary retention [6.6% for placebo vs 2.8% for
PROSCAR; 57% reduction in risk, 95% CI: (34 to 72%)]; see Figures 2 and 3.

Figure 2
Percent of Patients Having Surgery for BPH,
Including TURP
15%
Finasteride
Placebo

10%
Percent of Patients

5%

0%
0 4 8 12 16 20 24 28 32 36 40 44 48
Observation Time (Month)

Placebo Group
No. of events, cumulative 37 89 121 152
No. at risk, per year 1503 1454 1374 1314

Finasteride Group
No. of events, cumulative 18 40 49 69
No. at risk, per year 1513 1483 1438 1410

Figure 3
Percent of Patients Developing Acute Urinary Retention
(Spontaneous and Precipitated)
15%
Finasteride
Placebo

10%
Percent of Patients

5%

0%
0 4 8 12 16 20 24 28 32 36 40 44 48
Observation Time (Month)

Placebo Group
No. of events, cumulative 36 61 81 99
No. at risk, per year 1503 1454 1398 1347

Finasteride Group
No. of events, cumulative 14 25 32 42
No. at risk, per year 1513 1487 1449 1421

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PROSCAR® (Finasteride) Tablets 9631305

Effect on Maximum Urinary Flow Rate

In the patients in PLESS who remained on therapy for the duration of the study and had evaluable
urinary flow data, PROSCAR increased maximum urinary flow rate by 1.9 mL/sec compared with 0.2
mL/sec in the placebo group.
There was a clear difference between treatment groups in maximum urinary flow rate in favor of
PROSCAR by month 4 (1.0 vs 0.3 mL/sec) which was maintained throughout the study. In the earlier 1­
year studies, increase in maximum urinary flow rate was comparable to PLESS and was maintained
through the first year and throughout an additional 5 years of open extension studies.
Effect on Prostate Volume
In PLESS, prostate volume was assessed yearly by magnetic resonance imaging (MRI) in a subset of
patients. In patients treated with PROSCAR who remained on therapy, prostate volume was reduced
compared with both baseline and placebo throughout the 4-year study. PROSCAR decreased prostate
volume by 17.9% (from 55.9 cc at baseline to 45.8 cc at 4 years) compared with an increase of 14.1%
(from 51.3 cc to 58.5 cc) in the placebo group (p<0.001). (See Figure 4.)
Results seen in earlier studies were comparable to those seen in PLESS. Mean prostate volume at
baseline ranged between 40-50 cc. The reduction in prostate volume was seen during the first year and
maintained throughout an additional five years of open extension studies.

Figure 4
Prostate Volume in PLESS

20
Mean Percent Change from Baseline ± 1 SE

10

-10

-20
Baseline Year 1 Year 2 Year 3 Year 4

Placebo ( ) n = 155 136 119 98 85

Finasteride ( ) n = 157 144 130 116 102

Prostate Volume as a Predictor of Therapeutic Response

A meta-analysis combining 1-year data from seven double-blind, placebo-controlled studies of similar
design, including 4491 patients with symptomatic BPH, demonstrated that, in patients treated with
PROSCAR, the magnitude of symptom response and degree of improvement in maximum urinary flow
rate were greater in patients with an enlarged prostate at baseline.
Medical Therapy of Prostatic Symptoms
The Medical Therapy of Prostatic Symptoms (MTOPS) Trial was a double-blind, randomized,
placebo-controlled, multicenter, 4- to 6-year study (average 5 years) in 3047 men with symptomatic BPH,
who were randomized to receive PROSCAR 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the
combination of PROSCAR 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737). All
participants underwent weekly titration of doxazosin (or its placebo) from 1 to 2 to 4 to 8 mg/day. Only
those who tolerated the 4 or 8 mg dose level were kept on doxazosin (or its placebo) in the study. The
participant’s final tolerated dose (either 4 mg or 8 mg) was administered beginning at end-Week 4. The
final doxazosin dose was administered once per day, at bedtime.
The mean patient age at randomization was 62.6 years (±7.3 years). Patients were Caucasian (82%),
African American (9%), Hispanic (7%), Asian (1%) or Native American (<1%). The mean duration of BPH
symptoms was 4.7 years (±4.6 years). Patients had moderate to severe BPH symptoms at baseline with
a mean AUA symptom score of approximately 17 out of 35 points. Mean maximum urinary flow rate was
10.5 mL/sec (±2.6 mL/sec). The mean prostate volume as measured by transrectal ultrasound was
36.3 mL (±20.1 mL). Prostate volume was ≤20 mL in 16% of patients, ≥50 mL in 18% of patients and
between 21 and 49 mL in 66% of patients.
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The primary endpoint was a composite measure of the first occurrence of any of the following five
outcomes: a ≥4 point confirmed increase from baseline in symptom score, acute urinary retention, BPH-
related renal insufficiency (creatinine rise), recurrent urinary tract infections or urosepsis, or incontinence.
Compared to placebo, treatment with PROSCAR, doxazosin, or combination therapy resulted in a
reduction in the risk of experiencing one of these five outcome events by 34% (p=0.002), 39% (p<0.001),
and 67% (p<0.001), respectively. Combination therapy resulted in a significant reduction in the risk of the
primary endpoint compared to treatment with PROSCAR alone (49%; p≤0.001) or doxazosin alone (46%;
p≤0.001). (See Table 2.)

Table 2
Count and Percent Incidence of Primary Outcome Events
by Treatment Group in MTOPS

Treatment Group
Placebo Doxazosin Finasteride Combination Total
N=737 N=756 N=768 N=786 N=3047
Event N (%) N (%) N (%) N (%) N (%)

AUA 4-point rise 100 (13.6) 59 (7.8) 74 (9.6) 41 (5.2) 274 (9.0)
Acute urinary retention 18 (2.4) 13 (1.7) 6 (0.8) 4 (0.5) 41 (1.3)
Incontinence 8 (1.1) 11 (1.5) 9 (1.2) 3 (0.4) 31 (1.0)
Recurrent UTI/urosepsis 2 (0.3) 2 (0.3) 0 (0.0) 1 (0.1) 5 (0.2)
Creatinine rise 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Total Events 128 (17.4) 85 (11.2) 89 (11.6) 49 (6.2) 351 (11.5)

The majority of the events (274 out of 351; 78%) was a confirmed ≥4 point increase in symptom score,
referred to as symptom score progression. The risk of symptom score progression was reduced by 30%
(p=0.016), 46% (p<0.001), and 64% (p<0.001) in patients treated with PROSCAR, doxazosin, or the
combination, respectively, compared to patients treated with placebo (see Figure 5). Combination therapy
significantly reduced the risk of symptom score progression compared to the effect of PROSCAR alone
(p<0.001) and compared to doxazosin alone (p=0.037).

Figure 5
Cumulative Incidence of a 4-Point Rise in AUA Symptom Score by Treatment Group

25

20
Percent with Event

Placebo
15
Finasteride

10
Doxazosin

5 Combination

0
0.0 0.5 1.0 1.5 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5
Years from Randomization

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PROSCAR® (Finasteride) Tablets 9631305

Treatment with PROSCAR, doxazosin or the combination of PROSCAR with doxazosin, reduced the
mean symptom score from baseline at year 4. Table 3 provides the mean change from baseline for AUA
symptom score by treatment group for patients who remained on therapy for four years.

Table 3
Change From Baseline in AUA Symptom Score
by Treatment Group at Year 4 in MTOPS

Placebo Doxazosin Finasteride Combination

N=534 N=582 N=565 N=598
Baseline Mean (SD) 16.8 (6.0) 17.0 (5.9) 17.1 (6.0) 16.8 (5.8)
Mean Change
AUA Symptom Score (SD) -4.9 (5.8) -6.6 (6.1) -5.6 (5.9) -7.4 (6.3)
Comparison to -1.8 -0.7 -2.5
Placebo (95% CI) (-2.5, -1.1) (-1.4, 0.0) (-3.2, -1.8)
Comparison to -0.7
Doxazosin alone (95% CI) (-1.4, 0.0)
Comparison to -1.8
Finasteride alone (95% (-2.5, -1.1)
CI)

The results of MTOPS are consistent with the findings of the 4-year, placebo-controlled study PLESS
(see CLINICAL PHARMACOLOGY, Clinical Studies) in that treatment with PROSCAR reduces the risk of
acute urinary retention and the need for BPH-related surgery. In MTOPS, the risk of developing acute
urinary retention was reduced by 67% in patients treated with PROSCAR compared to patients treated
with placebo (0.8% for PROSCAR and 2.4% for placebo). Also, the risk of requiring BPH-related invasive
therapy was reduced by 64% in patients treated with PROSCAR compared to patients treated with
placebo (2.0% for PROSCAR and 5.4% for placebo).
Summary of Clinical Studies
The data from these studies, showing improvement in BPH-related symptoms, reduction in treatment
failure (BPH-related urological events), increased maximum urinary flow rates, and decreasing prostate
volume, suggest that PROSCAR arrests the disease process of BPH in men with an enlarged prostate.

INDICATIONS AND USAGE

PROSCAR is 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.
PROSCAR administered in combination with the alpha-blocker doxazosin is indicated to reduce the
risk of symptomatic progression of BPH (a confirmed ≥4 point increase in AUA symptom score).

CONTRAINDICATIONS
PROSCAR is contraindicated in the following:
Hypersensitivity to any component of this medication.
Pregnancy. Finasteride use is contraindicated in women when they are or may potentially be
pregnant. Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone
to DHT, finasteride may cause abnormalities of the external genitalia of a male fetus of a pregnant
woman who receives finasteride. If this drug is used during pregnancy, or if pregnancy occurs while
taking this drug, the pregnant woman should be apprised of the potential hazard to the male fetus. (See
also WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS and PRECAUTIONS, Information
for Patients and Pregnancy.) In female rats, low doses of finasteride administered during pregnancy have
produced abnormalities of the external genitalia in male offspring.

WARNINGS
PROSCAR is not indicated for use in pediatric patients (see PRECAUTIONS, Pediatric Use) or
women (see also WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS; PRECAUTIONS,
Information for Patients and Pregnancy; and HOW SUPPLIED).

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PROSCAR® (Finasteride) Tablets 9631305

EXPOSURE OF WOMEN — RISK TO MALE FETUS

Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may
potentially be pregnant because of the possibility of absorption of finasteride and the subsequent
potential risk to a male fetus. PROSCAR tablets are coated and will prevent contact with the active
ingredient during normal handling, provided that the tablets have not been broken or crushed. (See
CONTRAINDICATIONS; PRECAUTIONS, Information for Patients and Pregnancy; and HOW
SUPPLIED.)

PRECAUTIONS
General
Prior to initiating therapy with PROSCAR, appropriate evaluation should be performed to identify other
conditions such as infection, prostate cancer, stricture disease, hypotonic bladder or other neurogenic
disorders that might mimic BPH.
Patients with large residual urinary volume and/or severely diminished urinary flow should be carefully
monitored for obstructive uropathy. These patients may not be candidates for finasteride therapy.
Caution should be used in the administration of PROSCAR in those patients with liver function
abnormalities, as finasteride is metabolized extensively in the liver.
Effects on PSA and Prostate Cancer Detection
No clinical benefit has been demonstrated in patients with prostate cancer treated with PROSCAR.
Patients with BPH and elevated PSA were monitored in controlled clinical studies with serial PSAs and
prostate biopsies. In these BPH studies, PROSCAR did not appear to alter the rate of prostate cancer
detection, and the overall incidence of prostate cancer was not significantly different in patients treated
with PROSCAR or placebo.
PROSCAR causes a decrease in serum PSA levels by approximately 50% in patients with BPH. This
decrease is predictable over the entire range of PSA values, although it may vary in individual patients.
Analysis of PSA data from over 3000 patients in PLESS confirmed that in typical patients treated with
PROSCAR for six months or more, PSA values should be doubled for comparison with normal ranges in
untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains
its ability to detect prostate cancer. PROSCAR may also cause decreases in serum PSA in the presence
of prostate cancer.
Any confirmed increases in PSA levels from nadir while on PROSCAR may signal the presence of
prostate cancer and should be carefully evaluated, even if those values are still within the normal range
for men not taking a 5α-reductase inhibitor. Non-compliance with PROSCAR therapy may also affect
PSA test results.
Percent free PSA (free to total PSA ratio) is not significantly decreased by PROSCAR. The ratio of
free to total PSA remains constant even under the influence of PROSCAR. If clinicians elect to use
percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride therapy, no
adjustment to its value appears necessary.
Information for Patients
Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may
potentially be pregnant because of the possibility of absorption of finasteride and the subsequent
potential risk to the male fetus (see CONTRAINDICATIONS; WARNINGS, EXPOSURE OF WOMEN —
RISK TO MALE FETUS; PRECAUTIONS, Pregnancy and HOW SUPPLIED).
Physicians should inform patients that the volume of ejaculate may be decreased in some patients
during treatment with PROSCAR. This decrease does not appear to interfere with normal sexual function.
However, impotence and decreased libido may occur in patients treated with PROSCAR (see ADVERSE
REACTIONS).
Physicians should instruct their patients to promptly report any changes in their breasts such as
lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm
have been reported (see ADVERSE REACTIONS).
Physicians should instruct their patients to read the patient package insert before starting therapy
with PROSCAR and to reread it each time the prescription is renewed so that they are aware of current
information for patients regarding PROSCAR.
Drug/Laboratory Test Interactions
In patients with BPH, PROSCAR has no effect on circulating levels of cortisol, estradiol, prolactin,
thyroid-stimulating hormone, or thyroxine. No clinically meaningful effect was observed on the plasma
lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins and triglycerides) or
bone mineral density. Increases of about 10% were observed in luteinizing hormone (LH) and follicle­

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PROSCAR® (Finasteride) Tablets 9631305

stimulating hormone (FSH) in patients receiving PROSCAR, but levels remained within the normal range.
In healthy volunteers, treatment with PROSCAR did not alter the response of LH and FSH to
gonadotropin-releasing hormone indicating that the hypothalamic-pituitary-testicular axis was not
affected.
Treatment with PROSCAR for 24 weeks to evaluate semen parameters in healthy male volunteers
revealed no clinically meaningful effects on sperm concentration, mobility, morphology, or pH. A 0.6 mL
(22.1%) median decrease in ejaculate volume with a concomitant reduction in total sperm per ejaculate
was observed. These parameters remained within the normal range and were reversible upon
discontinuation of therapy with an average time to return to baseline of 84 weeks.
Drug Interactions
No drug interactions of clinical importance have been identified. Finasteride does not appear to affect
the cytochrome P450-linked drug metabolizing enzyme system. Compounds that have been tested in
man have included antipyrine, digoxin, propranolol, theophylline, and warfarin and no clinically
meaningful interactions were found.
Other Concomitant Therapy: Although specific interaction studies were not performed, PROSCAR
was concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers,
angiotensin-converting enzyme (ACE) inhibitors, analgesics, anti-convulsants, beta-adrenergic blocking
agents, diuretics, calcium channel blockers, cardiac nitrates, HMG-CoA reductase inhibitors, nonsteroidal
anti-inflammatory drugs (NSAIDs), benzodiazepines, H2 antagonists and quinolone anti-infectives without
evidence of clinically significant adverse interactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility
No evidence of a tumorigenic effect was observed in a 24-month study in Sprague-Dawley rats
receiving doses of finasteride up to 160 mg/kg/day in males and 320 mg/kg/day in females. These doses
produced respective systemic exposure in rats of 111 and 274 times those observed in man receiving the
recommended human dose of 5 mg/day. All exposure calculations were based on calculated AUC(0-24 hr)
for animals and mean AUC(0-24 hr) for man (0.4 μg•hr/mL).
In a 19-month carcinogenicity study in CD-1 mice, a statistically significant (p≤0.05) increase in the
incidence of testicular Leydig cell adenomas was observed at a dose of 250 mg/kg/day (228 times the
human exposure). In mice at a dose of 25 mg/kg/day (23 times the human exposure, estimated) and in
rats at a dose of ≥40 mg/kg/day (39 times the human exposure) an increase in the incidence of Leydig
cell hyperplasia was observed. A positive correlation between the proliferative changes in the Leydig cells
and an increase in serum LH levels (2- to 3-fold above control) has been demonstrated in both rodent
species treated with high doses of finasteride. No drug-related Leydig cell changes were seen in either
rats or dogs treated with finasteride for 1 year at doses of 20 mg/kg/day and 45 mg/kg/day (30 and 350
times, respectively, the human exposure) or in mice treated for 19 months at a dose of 2.5 mg/kg/day (2.3
times the human exposure, estimated).
No evidence of mutagenicity was observed in an in vitro bacterial mutagenesis assay, a mammalian
cell mutagenesis assay, or in an in vitro alkaline elution assay. In an in vitro chromosome aberration
assay, using Chinese hamster ovary cells, there was a slight increase in chromosome aberrations. These
concentrations correspond to 4000-5000 times the peak plasma levels in man given a total dose of 5 mg.
In an in vivo chromosome aberration assay in mice, no treatment-related increase in chromosome
aberration was observed with finasteride at the maximum tolerated dose of 250 mg/kg/day (228 times the
human exposure) as determined in the carcinogenicity studies.
In sexually mature male rabbits treated with finasteride at 80 mg/kg/day (543 times the human
exposure) for up to 12 weeks, no effect on fertility, sperm count, or ejaculate volume was seen. In
sexually mature male rats treated with 80 mg/kg/day of finasteride (61 times the human exposure), there
were no significant effects on fertility after 6 or 12 weeks of treatment; however, when treatment was
continued for up to 24 or 30 weeks, there was an apparent decrease in fertility, fecundity and an
associated significant decrease in the weights of the seminal vesicles and prostate. All these effects were
reversible within 6 weeks of discontinuation of treatment. No drug-related effect on testes or on mating
performance has been seen in rats or rabbits. This decrease in fertility in finasteride-treated rats is
secondary to its effect on accessory sex organs (prostate and seminal vesicles) resulting in failure to form
a seminal plug. The seminal plug is essential for normal fertility in rats and is not relevant in man.
Pregnancy
Pregnancy Category X
See CONTRAINDICATIONS.
PROSCAR is not indicated for use in women.
Administration of finasteride to pregnant rats at doses ranging from 100 μg/kg/day to 100 mg/kg/day
(1-1000 times the recommended human dose of 5 mg/day) resulted in dose-dependent development of
10
PROSCAR® (Finasteride) Tablets 9631305

hypospadias in 3.6 to 100% of male offspring. Pregnant rats produced male offspring with decreased
prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development
when given finasteride at ≥30 μg/kg/day (≥3/10 of the recommended human dose of 5 mg/day) and
decreased anogenital distance when given finasteride at ≥3 μg/kg/day (≥3/100 of the recommended
human dose of 5 mg/day). The critical period during which these effects can be induced in male rats has
been defined to be days 16-17 of gestation. The changes described above are expected pharmacological
effects of drugs belonging to the class of Type II 5α-reductase inhibitors and are similar to those reported
in male infants with a genetic deficiency of Type II 5α-reductase. No abnormalities were observed in
female offspring exposed to any dose of finasteride in utero.
No developmental abnormalities have been observed in first filial generation (F1) male or female
offspring resulting from mating finasteride-treated male rats (80 mg/kg/day; 61 times the human
exposure) with untreated females. Administration of finasteride at 3 mg/kg/day (30 times the
recommended human dose of 5 mg/day) during the late gestation and lactation period resulted in slightly
decreased fertility in F1 male offspring. No effects were seen in female offspring. No evidence of
malformations has been observed in rabbit fetuses exposed to finasteride in utero from days 6-18 of
gestation at doses up to 100 mg/kg/day (1000 times the recommended human dose of 5 mg/day).
However, effects on male genitalia would not be expected since the rabbits were not exposed during the
critical period of genital system development.
The in utero effects of finasteride exposure during the period of embryonic and fetal development
were evaluated in the rhesus monkey (gestation days 20-100), a species more predictive of human
development than rats or rabbits. Intravenous administration of finasteride to pregnant monkeys at doses
as high as 800 ng/day (at least 60 to 120 times the highest estimated exposure of pregnant women to
finasteride from semen of men taking 5 mg/day) resulted in no abnormalities in male fetuses. In
confirmation of the relevance of the rhesus model for human fetal development, oral administration of a
dose of finasteride (2 mg/kg/day; 20 times the recommended human dose of 5 mg/day or approximately
1-2 million times the highest estimated exposure to finasteride from semen of men taking 5 mg/day) to
pregnant monkeys resulted in external genital abnormalities in male fetuses. No other abnormalities were
observed in male fetuses and no finasteride-related abnormalities were observed in female fetuses at any
dose.
Nursing Mothers
PROSCAR is not indicated for use in women.
It is not known whether finasteride is excreted in human milk.
Pediatric Use
PROSCAR is not indicated for use in pediatric patients.
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Of the total number of subjects included in PLESS, 1480 and 105 subjects were 65 and over and 75
and over, respectively. No overall differences in safety or effectiveness were observed between these
subjects and younger subjects, and other reported clinical experience has not identified differences in
responses between the elderly and younger patients. No dosage adjustment is necessary in the elderly
(see CLINICAL PHARMACOLOGY, Pharmacokinetics and Clinical Studies).

ADVERSE REACTIONS
PROSCAR is generally well tolerated; adverse reactions usually have been mild and transient.
4-Year Placebo-Controlled Study
In PLESS, 1524 patients treated with PROSCAR 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 PROSCAR 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 4 presents the only clinical adverse reactions considered possibly, probably or definitely drug
related by the investigator, for which the incidence on PROSCAR was ≥1% and greater than placebo
over the 4 years of the study. In years 2-4 of the study, there was no significant difference between
treatment groups in the incidences of impotence, decreased libido and ejaculation disorder.

TABLE 4
Drug-Related Adverse Experiences
Year 1 Years 2, 3 and 4*
(%) (%)

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PROSCAR® (Finasteride) Tablets 9631305

Finasteride Placebo Finasteride Placebo

Impotence 8.1 3.7 5.1 5.1
Decreased 6.4 3.4 2.6 2.6
Libido
Decreased
Volume of 3.7 0.8 1.5 0.5
Ejaculate
Ejaculation 0.8 0.1 0.2 0.1
Disorder
Breast 0.5 0.1 1.8 1.1
Enlargement
Breast 0.4 0.1 0.7 0.3
Tenderness
Rash 0.5 0.2 0.5 0.1
*Combined Years 2-4
N = 1524 and 1516, finasteride vs placebo, respectively

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 PLESS were similar.
Medical Therapy of Prostatic Symptoms (MTOPS) Study
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 5.
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 5). 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 ADVERSE REACTIONS, 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 5
Incidence ≥ 2% in One or More Treatment Groups
Drug-Related Clinical Adverse Experiences in MTOPS
Adverse Experience Placebo Doxazosin Finasteride Combination
4 mg or 8 mg*
(N=737) (N=756) (N=768) (N=786)
(%) (%) (%) (%)
Body as a whole
Asthenia 7.1 15.7 5.3 16.8
Headache 2.3 4.1 2.0 2.3
Cardiovascular
Hypotension 0.7 3.4 1.2 1.5
Postural Hypotension 8.0 16.7 9.1 17.8
Metabolic and Nutritional
Peripheral Edema 0.9 2.6 1.3 3.3
Nervous
Dizziness 8.1 17.7 7.4 23.2
Libido Decreased 5.7 7.0 10.0 11.6
Somnolence 1.5 3.7 1.7 3.1
Respiratory
Dyspnea 0.7 2.1 0.7 1.9
Rhinitis 0.5 1.3 1.0 2.4
Urogenital

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PROSCAR® (Finasteride) Tablets 9631305

Abnormal Ejaculation 2.3 4.5 7.2 14.1

Gynecomastia 0.7 1.1 2.2 1.5
Impotence 12.2 14.4 18.5 22.6
Sexual Function Abnormal 0.9 2.0 2.5 3.1
*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.

Long-Term Data
There is no evidence of increased adverse experiences with increased duration of treatment with
PROSCAR. New reports of drug-related sexual adverse experiences decreased with duration of therapy.
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 PLESS study that enrolled 3040 men, there were 2
cases of breast cancer in placebo-treated men, but no cases were reported in men treated with
finasteride. The relationship between long-term use of finasteride and male breast neoplasia is currently
unknown.
In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle
biopsy data available for analysis. In the PROSCAR group, 280 (6.4%) men had prostate cancer with
Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total
cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular
(stage T1 or T2). The clinical significance of these findings is unknown. This information from the
literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the
development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by
physicians when PROSCAR is used as indicated (see INDICATIONS AND USAGE). PROSCAR is not
approved to reduce the risk of developing prostate cancer.
Post-Marketing Experience
The following additional adverse effects have been reported in post-marketing experience:
- hypersensitivity reactions, including pruritus, urticaria, and swelling of the lips and face
- testicular pain
- male breast cancer.

OVERDOSAGE
Patients have received single doses of PROSCAR up to 400 mg and multiple doses of PROSCAR up
to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific
treatment for an overdose with PROSCAR can be recommended.
2
Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m (500
mg/kg) and in female and male rats at single oral doses of 2360 mg/m (400 mg/kg) and 5900 mg/m2
2

(1000 mg/kg), respectively.

DOSAGE AND ADMINISTRATION

The recommended dose is 5 mg orally once a day.
PROSCAR can be administered alone or in combination with the alpha-blocker doxazosin (see
CLINICAL PHARMACOLOGY, Clinical Studies).
PROSCAR may be administered with or without meals.
No dosage adjustment is necessary for patients with renal impairment or for the elderly (see
CLINICAL PHARMACOLOGY, Pharmacokinetics).

HOW SUPPLIED
No. 3094 — PROSCAR tablets 5 mg are blue, modified apple-shaped, film-coated tablets, with the
code MSD 72 on one side and PROSCAR on the other. They are supplied as follows:
NDC 0006-0072-31 unit of use bottles of 30
NDC 0006-0072-58 unit of use bottles of 100
Storage and Handling
Store at room temperatures below 30°C (86°F). Protect from light and keep container tightly closed.
Women should not handle crushed or broken PROSCAR tablets when they are pregnant or may
potentially be pregnant because of the possibility of absorption of finasteride and the subsequent

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PROSCAR® (Finasteride) Tablets 9631305

potential risk to a male fetus (see WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS,
and PRECAUTIONS, Information for Patients and Pregnancy).

Issued October 2010

Printed in USA

14
 PROSCAR® (Finasteride) Tablets
Patient Information about
PROSCAR® (Prahs-car)
Generic name: finasteride
(fin-AS-tur-eyed)
*
PROSCAR is for use by men only.

Please read this leaflet before you start taking PROSCAR. Also, read it each time you renew your
prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful
discussions with your doctor. You and your doctor should discuss PROSCAR when you start taking your
medication and at regular checkups.

What is PROSCAR?

PROSCAR is a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an
enlarged prostate. PROSCAR may also be used to reduce the risk of a sudden inability to pass urine and
the need for surgery related to BPH in men with an enlarged prostate.

PROSCAR may be prescribed along with another medicine, an alpha-blocker called doxazosin, to help
you better manage your BPH symptoms.

Who should NOT take PROSCAR?

PROSCAR is for use by MEN only.

Do Not Take PROSCAR if you are:

• a woman who is pregnant or may potentially be pregnant. PROSCAR may harm your unborn
baby. Do not touch or handle crushed or broken PROSCAR tablets (see “A warning about
PROSCAR and pregnancy”).
• allergic to finasteride or any of the ingredients in PROSCAR. See the end of this leaflet for a
complete list of ingredients in PROSCAR.

A warning about PROSCAR and pregnancy:

Women who are or may potentially be pregnant must not use PROSCAR. They should also not handle
crushed or broken tablets of PROSCAR. PROSCAR tablets are coated and will prevent contact with the
active ingredient during normal handling, provided that the tablets are not broken or crushed.

If a woman who is pregnant with a male baby absorbs the active ingredient in PROSCAR after oral use or
through the skin, it may cause the male baby to be born with abnormalities of the sex organs. If a woman
who is pregnant comes into contact with the active ingredient in PROSCAR, a doctor should be
consulted.

How should I take PROSCAR?

Follow your doctor's instruction.

• Take one tablet by mouth each day. To avoid forgetting to take PROSCAR, you can take it at the
same time every day.
• If you forget to take PROSCAR, do not take an extra tablet. Just take the next tablet as usual.
*
Registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Copyright © 1992, 1995, 1998 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved
PROSCAR® (Finasteride) Tablets 9631305

• You may take PROSCAR with or without food.

• Do not share PROSCAR with anyone else; it was prescribed only for you.

What are the possible side effects of PROSCAR?

The most common side effects of PROSCAR include:

• trouble getting or keeping an erection (impotence)
• decrease in sex drive
• decreased volume of ejaculate
• ejaculation disorders
• enlarged or painful breast. You should promptly report to your doctor any changes in your breasts
such as lumps, pain or nipple discharge.

In addition, the following have been reported in general use with PROSCAR:
• allergic reactions, including rash, itching, hives, and swelling of the lips and face
• rarely, some men may have testicular pain
• in rare cases, male breast cancer has been reported.

You should discuss side effects with your doctor before taking PROSCAR and anytime you think you are
having a side effect. These are not all the possible side effects with PROSCAR. For more information,
ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at: 1-800-FDA­
1088.

What you need to know while taking PROSCAR:

• You should see your doctor regularly while taking PROSCAR. Follow your doctor's advice
about when to have these checkups.
• Checking for prostate cancer. Your doctor has prescribed PROSCAR for BPH and not for
treatment of prostate cancer — but a man can have BPH and prostate cancer at the same time.
Checking for prostate cancer should continue while you take PROSCAR.
• About Prostate-Specific Antigen (PSA). Your doctor may have done a blood test called PSA
for the screening of prostate cancer. Because PROSCAR decreases PSA levels, you should tell
your doctor(s) that you are taking PROSCAR. Changes in PSA levels will need to be carefully
evaluated by your doctor(s). Any increase in follow-up PSA levels from their lowest point should
be carefully evaluated, even if the test results are still within the normal range. You should also
tell your doctor if you have not been taking PROSCAR as prescribed because this may affect the
PSA test results. For more information, talk to your doctor.

How should I store PROSCAR?

• Store PROSCAR tablets in a dry place at room temperature.

• Keep PROSCAR in the original container and keep the container closed.
PROSCAR tablets are coated and will prevent contact with the active ingredient during
normal handling, provided that the tablets are not broken or crushed.

Keep PROSCAR and all medications out of the reach of children.

Do not give your PROSCAR tablets to anyone else. It has been prescribed only for you.

For more information call 1-800-633-4477.

2
PROSCAR® (Finasteride) Tablets 9631305

What are the ingredients in PROSCAR?

Active ingredients: finasteride

Inactive ingredients: hydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch
glycolate, hydroxypropyl cellulose LF, hydroxypropyl methylcellulose, titanium dioxide, magnesium
stearate, talc, docusate sodium, FD&C Blue 2 aluminum lake and yellow iron oxide.

What is BPH?

BPH is an enlargement of the prostate gland. The prostate is located below the bladder. As the prostate
enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:

• a weak or interrupted urinary stream

• a feeling that you cannot empty your bladder completely
• a feeling of delay or hesitation when you start to urinate
• a need to urinate often, especially at night
• a feeling that you must urinate right away.

In some men, BPH can lead to serious problems, including urinary tract infections, a sudden inability to
pass urine (acute urinary retention), as well as the need for surgery.

What PROSCAR does:

PROSCAR lowers levels of a hormone called DHT (dihydrotestosterone), which is a cause of prostate
growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to
gradual improvement in urine flow and symptoms over the next several months. PROSCAR will help
reduce the risk of developing a sudden inability to pass urine and the need for surgery related to an
enlarged prostate. However, since each case of BPH is different, you should know that:

• Even though the prostate shrinks, you may NOT notice an improvement in urine flow or
symptoms.
• You may need to take PROSCAR for six (6) months or more to see whether it improves your
symptoms.
• Therapy with PROSCAR may reduce your risk for a sudden inability to pass urine and the need
for surgery for an enlarged prostate.

Issued October 2010