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WARNINGS Finasteride 5 mg tablets 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 ). EXPOSURE OF WOMEN — RISK TO MALE FETUS Women should not handle crushed or broken finasteride 5 mg 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. Finasteride 5 mg 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 .)
ADVERSE REACTIONS Finasteride 5 mg tablets are generally well tolerated; adverse reactions usually have been mild and transient. 4-Year Placebo-Controlled Study In PLESS, 1524 patients treated with finasteride 5 mg tablets 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 5 mg tablets 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 finasteride 5 mg tablets were ≥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 Combined Years 2–4 (%) N = 1524 and 1516, finasteride vs placebo, respectively Finasteride Placebo Finasteride Placebo 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 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 4 mg or 8 mg 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. Finasteride Combination (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 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 There is no evidence of increased adverse experiences with increased duration of treatment with finasteride 5 mg tablets. 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 finasteride 5 mg tablets 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 prostatecancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when finasteride 5 mg tablets are used as indicated (see INDICATIONS AND USAGE ). Finasteride 5 mg tablets are 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.