FDA label 4cfed91f-c1e3-0c8b-e054-00144ff88e88

WARNINGS Finasteride tablets USP are 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 tablets USP 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 tablets USP 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 tablets USP are generally well tolerated; adverse reactions usually have been mild and transient. 4-Year Placebo-Controlled Study In a long-term efficacy and safety study, 1524 patients treated with finasteride tablets USP 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 tablets USP 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 2 presents the only clinical adverse reactions considered possibly, probably or definitely drug related by the investigator, for which the incidence on finasteride tablets USP was ≥1% and greater than placebo over the 4 years of the study. In years 2 to 4 of the study, there was no significant difference between treatment groups in the incidences of impotence, decreased libido and ejaculation disorder. TABLE 2 Drug-Related Adverse Experiences Year 1(%) Years 2, 3 and 4* (%) 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 a long-term efficacy and safety study were similar. Long-Term Data There is no evidence of increased adverse experiences with increased duration of treatment with finasteride tablets USP. New reports of drug-related sexual adverse experiences decreased with duration of therapy. During the 4- to 6-year placebo- and comparator-controlled 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 long-term efficacy and safety 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 tablets USP group, 280 (6.4%) men had prostate cancer with Gleason scores of 7 to 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 finasteride tablets USP are used as indicated (see INDICATIONS AND USAGE ). Finasteride tablets USP 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.

<table width="566"> <caption> TABLE 2 Drug-Related Adverse Experiences</caption> <tbody> <tr> <td/> <td> Year 1(%) </td> <td> Years 2, 3 and 4* (%) </td> </tr> <tr> <td> Finasteride</td> <td> Placebo</td> <td> Finasteride</td> <td> Placebo</td> </tr> <tr> <td>Impotence</td> <td>8.1</td> <td>3.7</td> <td>5.1</td> <td>5.1</td> </tr> <tr> <td>Decreased Libido</td> <td>6.4</td> <td>3.4</td> <td>2.6</td> <td>2.6</td> </tr> <tr> <td>Decreased Volume of Ejaculate</td> <td>3.7</td> <td>0.8</td> <td>1.5</td> <td>0.5</td> </tr> <tr> <td>Ejaculation Disorder</td> <td>0.8</td> <td>0.1</td> <td>0.2</td> <td>0.1</td> </tr> <tr> <td>Breast Enlargement</td> <td>0.5</td> <td>0.1</td> <td>1.8</td> <td>1.1</td> </tr> <tr> <td>Breast Tenderness</td> <td>0.4</td> <td>0.1</td> <td>0.7</td> <td>0.3</td> </tr> <tr> <td>Rash</td> <td>0.5</td> <td>0.2</td> <td>0.5</td> <td>0.1</td> </tr> </tbody> </table>