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Prostanus

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Prostanus uses


1 INDICATIONS AND USAGE

Prostanus, is a 5α-reductase inhibitor, indicated for the treatment of symptomatic benign prostatic hyperplasia in men with an enlarged prostate to (1.1):


Prostanus 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 American Urological Association (AUA) symptom score) (1.2).

Limitations of Use: Prostanus is not approved for the prevention of prostate cancer (1.3).

1.1 Monotherapy

Prostanus® is indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

1.2 Combination with Alpha-Blocker

Prostanus administered in combination with the alpha-blocker doxazosin is indicated to reduce the risk of symptomatic progression of BPH symptom score).

1.3 Limitations of Use

Prostanus is not approved for the prevention of prostate cancer.

2 DOSAGE AND ADMINISTRATION

Prostanus may be administered with or without meals.

Prostanus may be administered with or without meals.

Monotherapy: One tablet (5 mg) taken once a day (2.1).

Combination with Doxazosin: One tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin (2.2).

2.1 Monotherapy

The recommended dose of Prostanus is one tablet (5 mg) taken once a day .

2.2 Combination with Alpha-Blocker

The recommended dose of Prostanus is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin .

3 DOSAGE FORMS AND STRENGTHS

5-mg blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and Prostanus on the other.

5-mg film-coated tablets (3).

4 CONTRAINDICATIONS

Prostanus is contraindicated in the following:


Hypersensitivity to any components of this product (4).

Women who are or may potentially be pregnant (4, 5.4, 8.1, 16).

5 WARNINGS AND PRECAUTIONS

5.1 Effects on Prostate Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection

In clinical studies, Prostanus reduced serum PSA concentration by approximately 50% within six months of treatment. This decrease is predictable over the entire range of PSA values in patients with symptomatic BPH, although it may vary in individuals.

For interpretation of serial PSAs in men taking Prostanus, a new PSA baseline should be established at least six months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on Prostanus may signal the presence of prostate cancer and should be evaluated, even if PSA levels are still within the normal range for men not taking a 5α-reductase inhibitor. Non-compliance with Prostanus therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with Prostanus for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. These adjustments preserve the utility of PSA to detect prostate cancer in men treated with Prostanus.

Prostanus may also cause decreases in serum PSA in the presence of prostate cancer.

The ratio of free to total PSA (percent free PSA) remains constant even under the influence of Prostanus. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing Prostanus therapy, no adjustment to its value appears necessary.

5.2 Increased Risk of High-Grade Prostate Cancer

Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking Prostanus 5 mg/day in the 7-year Prostate Cancer Prevention Trial had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART) (1% dutasteride vs 0.5% placebo). 5α-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5α-reductase inhibitors to reduce prostate volume, or study-related factors, impacted the results of these studies has not been established.

5.3 Exposure of Women - Risk to Male Fetus

Women should not handle crushed or broken Prostanus tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of Prostanus and the subsequent potential risk to a male fetus. Prostanus tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed.

5.4 Pediatric Patients and Women

Prostanus is not indicated for use in pediatric patients or women .

5.5 Effect on Semen Characteristics

Treatment with Prostanus 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.

5.6 Consideration of Other Urological Conditions

Prior to initiating treatment with Prostanus, consideration should be given to other urological conditions that may cause similar symptoms. In addition, prostate cancer and BPH may coexist.

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 Prostanus therapy.

6 ADVERSE REACTIONS

The drug-related adverse reactions, reported in ≥1% in patients treated with Prostanus 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 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 Clinical Trials Experience

Prostanus is generally well tolerated; adverse reactions usually have been mild and transient.

4-Year Placebo-Controlled Study (PLESS)

In PLESS, 1524 patients treated with Prostanus 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 Prostanus 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 Prostanus 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.

Year 1

(%)

 Years 2, 3 and 4Combined Years 2-4

(%)
Prostanus Placebo Prostanus Placebo
N = 1524 and 1516, Prostanus 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 PLESS were similar.

Medical Therapy of Prostatic Symptoms (MTOPS) Study

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

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. 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 Prostanus 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 Prostanus only and one was on combination therapy.

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.

Adverse Experience Placebo

(N=737)

(%)

 Doxazosin

4 mg or 8 mgDoxazosin 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.

(N=756)

(%)

 Prostanus

(N=768)

(%)

 Combination

(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
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
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 ≤3.0 ng/mL. Men received either Prostanus (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 8-10 prostate cancer was higher in men treated with Prostanus (1.8%) than in those treated with placebo (1.1%) . In a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride, AVODART), similar results for Gleason score 8-10 prostate cancer were observed (1% dutasteride vs 0.5% placebo).

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

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 Prostanus but no cases in men not treated with Prostanus. 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 in men treated with Prostanus. 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 Prostanus, and 1 case of breast cancer in men treated with placebo. The relationship between long-term use of Prostanus and male breast neoplasia is currently unknown.

Sexual Function

There is no evidence of increased sexual adverse experiences with increased duration of treatment with Prostanus. 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 Prostanus. 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:


The following additional adverse event related to sexual dysfunction that continued after discontinuation of treatment has been reported in postmarketing experience with Prostanus 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:

7 DRUG INTERACTIONS

7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System

No drug interactions of clinical importance have been identified. Prostanus 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.

7.2 Other Concomitant Therapy

Although specific interaction studies were not performed, Prostanus 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.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category X.

Prostanus is contraindicated for use in women who are or may become pregnant. Prostanus is a Type II 5α-reductase inhibitor that prevents conversion of testosterone to 5α-dihydrotestosterone (DHT), a hormone necessary for normal development of male genitalia. In animal studies, Prostanus caused abnormal development of external genitalia in male fetuses. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the male fetus.

Abnormal male genital development is an expected consequence when conversion of testosterone to 5α-dihydrotestosterone (DHT) is inhibited by 5α-reductase inhibitors. These outcomes are similar to those reported in male infants with genetic 5α-reductase deficiency. Women could be exposed to Prostanus through contact with crushed or broken Prostanus tablets or semen from a male partner taking Prostanus. With regard to Prostanus exposure through the skin, Prostanus tablets are coated and will prevent skin contact with Prostanus during normal handling if the tablets have not been crushed or broken. Women who are pregnant or may become pregnant should not handle crushed or broken Prostanus tablets because of possible exposure of a male fetus. If a pregnant woman comes in contact with crushed or broken Prostanus tablets, the contact area should be washed immediately with soap and water. With regard to potential Prostanus exposure through semen, two studies have been conducted in men receiving Prostanus 5 mg/day that measured Prostanus concentrations in semen .

In an embryo-fetal development study, pregnant rats received Prostanus during the period of major organogenesis (gestation days 6 to 17). At maternal doses of oral Prostanus approximately 0.1 to 86 times the maximum recommended human dose (MRHD) of 5 mg/day (based on AUC at animal doses of 0.1 to 100 mg/kg/day) there was a dose-dependent increase in hypospadias that occurred in 3.6 to 100% of male offspring. Exposure multiples were estimated using data from nonpregnant rats. Days 16 to 17 of gestation is a critical period in male fetal rats for differentiation of the external genitalia. At oral maternal doses approximately 0.03 times the MRHD (based on AUC at animal dose of 0.03 mg/kg/day), male offspring had decreased prostatic and seminal vesicular weights, delayed preputial separation and transient nipple development. Decreased anogenital distance occurred in male offspring of pregnant rats that received approximately 0.003 times the MRHD (based on AUC at animal dose of 0.003 mg/kg/day). No abnormalities were observed in female offspring at any maternal dose of Prostanus.

No developmental abnormalities were observed in the offspring of untreated females mated with Prostanus treated male rats that received approximately 61 times the MRHD (based on AUC at animal dose of 80 mg/kg/day). Slightly decreased fertility was observed in male offspring after administration of about 3 times the MRHD (based on AUC at animal dose of 3 mg/kg/day) to female rats during late gestation and lactation. No effects on fertility were seen in female offspring under these conditions.

No evidence of male external genital malformations or other abnormalities were observed in rabbit fetuses exposed to Prostanus during the period of major organogenesis (gestation days 6-18) at maternal oral doses up to 100 mg/kg/day, (finasteride exposure levels were not measured in rabbits). However, this study may not have included the critical period for Prostanus effects on development of male external genitalia in the rabbit.

The fetal effects of maternal Prostanus exposure during the period of embryonic and fetal development were evaluated in the rhesus monkey (gestation days 20-100), in a species and development period more predictive of specific effects in humans than the studies in rats and rabbits. Intravenous administration of Prostanus to pregnant monkeys at doses as high as 800 ng/day (estimated maximal blood concentration of 1.86 ng/mL or about 143 times the highest estimated exposure of pregnant women to Prostanus 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 Prostanus (2 mg/kg/day or approximately 18,000 times the highest estimated blood levels of Prostanus 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.

8.3 Nursing Mothers

Prostanus is not indicated for use in women.

It is not known whether Prostanus is excreted in human milk.

8.4 Pediatric Use

Prostanus is not indicated for use in pediatric patients.

Safety and effectiveness in pediatric patients have not been established.

8.5 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 .

8.6 Hepatic Impairment

Caution should be exercised in the administration of Prostanus in those patients with liver function abnormalities, as Prostanus is metabolized extensively in the liver .

8.7 Renal Impairment

No dosage adjustment is necessary in patients with renal impairment .

10 OVERDOSAGE

Patients have received single doses of Prostanus up to 400 mg and multiple doses of Prostanus up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with Prostanus can be recommended.

Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m2 (400 mg/kg) and 5900 mg/m2 (1000 mg/kg), respectively.

11 DESCRIPTION

Prostanus, 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).

Prostanus is 4-azaandrost-1-ene-17-carboxamide, N-(1,1-dimethylethyl)-3-oxo-,(5α,17ß)-. The empirical formula of Prostanus is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:

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 5) summarizes the results.


 Patients (%)patients with multiple events may be counted more than once for each type of event



Event Placebo

N=1503

Prostanus

N=1513

Relative

RiskHazard ratio based on log rank test

95% CI P

Value

All Treatment Failures 37.1 26.2 0.68 (0.57 to 0.79) <0.001
Surgical

Interventions for

BPH

10.1 4.6 0.45 (0.32 to 0.63) <0.001
Acute Urinary

Retention

Requiring

Catheterization

 6.6 2.8 0.43 (0.28 to 0.66) <0.001
Two consecutive

symptom scores

≥20

 9.2 6.7
Bladder Stone 0.4 0.5
Incontinence 2.1 1.7
Renal Failure 0.5 0.6
UTI 5.7 4.9
Discontinuation

due to worsening

of BPH, lack of

improvement, or

to receive other

medical treatment

 21.8 13.3

Compared with placebo, Prostanus 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 Prostanus; 51% reduction in risk, 95% CI: (34 to 63%)]. Compared with placebo, Prostanus was associated with a significantly lower risk for surgery [10.1% for placebo vs 4.6% for Prostanus; 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 Prostanus; 57% reduction in risk, 95% CI: (34 to 72%)]; see Figures 2 and 3.

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, Prostanus 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 Prostanus 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 Prostanus who remained on therapy, prostate volume was reduced compared with both baseline and placebo throughout the 4-year study. Prostanus 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).

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.

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 Prostanus, the magnitude of symptom response and degree of improvement in maximum urinary flow rate were greater in patients with an enlarged prostate at baseline.

14.2 Combination with Alpha-Blocker Therapy

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 Prostanus 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of Prostanus 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.

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 Prostanus, 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 Prostanus alone (49%; p≤0.001) or doxazosin alone (46%; p≤0.001).

Treatment Group
Placebo Doxazosin Prostanus 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 Prostanus, doxazosin, or the combination, respectively, compared to patients treated with placebo. Combination therapy significantly reduced the risk of symptom score progression compared to the effect of Prostanus alone (p<0.001) and compared to doxazosin alone (p=0.037).

Treatment with Prostanus, doxazosin or the combination of Prostanus with doxazosin, reduced the mean symptom score from baseline at year 4. Table 7 provides the mean change from baseline for AUA symptom score by treatment group for patients who remained on therapy for four years.

Placebo

N=534

Doxazosin

N=582

Prostanus

N=565

Combination

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

Placebo (95% CI)

 -1.8

(-2.5, -1.1)

 -0.7

(-1.4, 0.0)

 -2.5

(-3.2, -1.8)
Comparison to

Doxazosin alone (95% CI)

 -0.7

(-1.4, 0.0)
Comparison to

Prostanus alone (95% CI)

 -1.8

(-2.5, -1.1)

The results of MTOPS are consistent with the findings of the 4-year, placebo-controlled study PLESS in that treatment with Prostanus 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 Prostanus compared to patients treated with placebo (0.8% for Prostanus and 2.4% for placebo). Also, the risk of requiring BPH-related invasive therapy was reduced by 64% in patients treated with Prostanus compared to patients treated with placebo (2.0% for Prostanus and 5.4% for placebo).

14.3 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 Prostanus arrests the disease process of BPH in men with an enlarged prostate.

Image of Figure 1 Image of Figure 2 Image of Figure 3 Image of Figure 4 Image of Figure 5

16 HOW SUPPLIED/STORAGE AND HANDLING

No. 3094 - Prostanus tablets 5 mg are blue, modified apple-shaped, film-coated tablets, with the code MSD 72 on one side and Prostanus 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 Prostanus tablets when they are pregnant or may potentially be pregnant because of the possibility of absorption of Prostanus and the subsequent potential risk to a male fetus .

17 PATIENT COUNSELING INFORMATION

17.1 Increased Risk of High-Grade Prostate Cancer

Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including Prostanus, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer .

17.2 Exposure of Women - Risk to Male Fetus

Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken Prostanus tablets because of the possibility of absorption of Prostanus and the subsequent potential risk to the male fetus. Prostanus tablets are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets have not been broken or crushed. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken Prostanus tablets, the contact area should be washed immediately with soap and water .

17.3 Additional Instructions

Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with Prostanus. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with Prostanus .

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 .

Physicians should instruct their patients to read the patient package insert before starting therapy with Prostanus and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding Prostanus.

Dist. by: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1992, 1995, 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

uspi-mk0906-5t-1309r011

Prostanus® (finasteride) Tablets

Patient Information about

Prostanus® (Prahs-car)

Generic name: Prostanus

(fin-AS-tur-eyed)

Prostanus is for use by men only.

Please read this leaflet before you start taking Prostanus. 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 Prostanus when you start taking your medication and at regular checkups.

What is Prostanus?

Prostanus is a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Prostanus 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.

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

Who should NOT take Prostanus?

Prostanus is for use by MEN only.

Do Not Take Prostanus if you are:


A warning about Prostanus and pregnancy:

Women who are or may potentially be pregnant must not use Prostanus. They should also not handle crushed or broken tablets of Prostanus. Prostanus 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 Prostanus 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 Prostanus, a doctor should be consulted.

How should I take Prostanus?

Follow your doctor's instruction.


What are the possible side effects of Prostanus?

Prostanus may increase the chance of a more serious form of prostate cancer.

The most common side effects of Prostanus include:


The following have been reported in general use with Prostanus and/or Prostanus at lower doses:


You should discuss side effects with your doctor before taking Prostanus and anytime you think you are having a side effect. These are not all the possible side effects with Prostanus. 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 Prostanus:


How should I store Prostanus?


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

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

For more information call 1-800-622-4477.

What are the ingredients in Prostanus?

Active ingredients: Prostanus

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:


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 Prostanus does:

Prostanus 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. Prostanus 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:


Dist. by: Merck Sharp & Dohme Corp., a subsidiary of

MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

For patent information: www.merck.com/product/patent/home.html

Copyright © 1992, 1995, 1998, 2011 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

All rights reserved.

Revised: 09/2013

usppi-mk0906-5t-1309r011

PRINCIPAL DISPLAY PANEL - 5 mg Bottle Label

NDC 0006-0072-31

Prostanus®

(finasteride) Tablets

5 mg

WARNING: Prostanus® (finasteride) should

not be used by women or children.

Women who are or may potentially be

pregnant must not use Prostanus. They

should also not handle crushed or broken

tablets of Prostanus.

Rx only

30 Tablets

Prostanus pharmaceutical active ingredients containing related brand and generic drugs:


Prostanus available forms, composition, doses:


Prostanus destination | category:


Prostanus Anatomical Therapeutic Chemical codes:


Prostanus pharmaceutical companies:


References

  1. Dailymed."PROSCAR (FINASTERIDE) TABLET, FILM COATED [MERCK SHARP & DOHME CORP.]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."FINASTERIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "finasteride". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Prostanus?

Depending on the reaction of the Prostanus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Prostanus not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Prostanus addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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