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warnings and cautions
5 WARNINGS AND PRECAUTIONS Finasteride tablets is not indicated for use in women or pediatric patients ( 5.1 , 5.4 ). Women should not handle crushed or broken finasteride tablets when they are pregnant or may potentially be pregnant due to potential risk to a male fetus ( 5.1 , 8.1 , 16 ). Finasteride tablets causes a decrease in serum PSA levels. Any confirmed increase in PSA while on finasteride tablets may signal the presence of prostate cancer and should be evaluated, even if those values are still w ithin the normal range for men not taking a 5α-reductase inhibitor ( 5 . 2 ). 5α-reductase inhibitors may increase the risk of high - grade prostate cancer ( 5 . 3 , 6 . 1 ). 5.1 Exposure of Women-Risk to Male Fetus Finasteride tablets is not indicated for use in women. Women should not handle crushed or broken finasteride 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 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 Indications and Usage (1) , Contraindicat ions (4) , Use in Specific Populations (8.1) , How Supplied / Storage and Handling ( 16 ) and Patient Counseling Infor mation (17.1) .] 5.2 Effects on Prostate Specific Antigen (PSA) In clinical studies with finasteride tablets 1 mg (finasteride, 1 mg) in men 18 to 41 years of age, the mean value of serum prostate specific antigen (PSA) decreased from 0.7 ng/mL at ba seline to 0.5 ng/mL at Month 12. Further, in clinical studies with finasteride tablets 5 mg (fina steride, 5 mg) when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approxi mately 50%. Other studies with finasteride tablets 5 mg showed it may al so cau se de crea ses in serum PSA in the pre sen ce of pro state can cer. The se findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with fina steride. Any confirmed increa se f rom the lowest PSA value while on finasteride tablets 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 5 α-reductase inhibitor. Non-compl iance to therapy with finasteride tablets may also affe ct PSA te st re sult s 5.3 Increased Risk of High-Grade Prostate Cancer with 5a-Reductase Inhibitors Men aged 55 and over with a normal digital rectal examination and PSA ≤3.0 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of finasteride tablets) in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8 to 10 prost ate cancer (finasteride 1.8% vs placebo 1.1%). [ See Adverse Reactions (6.1) .] 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. 5.4 Pediatric Patients Finasteride Tablets is not indicated for use in pediatric patients [ see Use in Specific Populations (8.4) ] .
6 ADVERSE REACTIONS The most common adverse reactions, reported in ≥1% of patients treated w ith finasteride tablets and greater than in patients treated w ith placebo are: decreased libido, ere ctile d ysfunction and ejaculation disorder ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Ascend Laboratories, LLC at 1-877-ASC-RX01 (877-272-7901) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are condu cted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates obse rved in clinical practice. Clinical Studies for finasteride tablets 1 mg in the Treatment of Male Pattern Hair Loss In three controlled clinical trials for finasteride tablets of 12-month duration, 1.4% of patients taking finasteride tablets (n=945) were discontinued due to adverse experiences that were considered to be possibly, probably or definitely drug-related (1.6% for placebo; n=934). Clinical adverse experiences that were reported as possibly, probably or definitely drug-related in > 1% of patients treated with finasteride tablets or placebo are presented in Table 1. T ABLE 1: Drug-Related Ad verse Experiences for Finasteride tablets 1 mg (finasteride 1 mg) in Year 1 ( %) M ALE P ATTERN H AIR LOSS Finasteride N=945 Placebo N=934 Decreased Libido 1.8 1.3 Erectile D ysfunction 1.3 0.7 Ejaculation Disorder (Decreased Volu me of Ejaculate) 1.2 (0.8) 0.7 (0.4) Discontinuation due to drug-related sexual adverse experiences 1.2 0.9 Integrated analysis of clinical adverse experiences showed that during treatment with finasteride tablets, 36 (3.8%) of 945 men had reported one or more of these adverse experiences as compared to 20 (2.1%) of 934 men treated with placebo (p=0.04). Resolution occurred in men who discontinued therapy with finasteride tablets due to these side effects and in most of those who continued therapy. The incidence of each of the above adverse experiences decreased to < 0.3% by the fifth year of treatment with finasteride tablets. In a study of finasteride 1 mg daily in healthy men, a median decrease in ejaculate volume of 0.3 mL (-11%) compared with 0.2 mL (-8%) for placebo was observed after 48 weeks of treatment. Two other studies showed that finasteride at 5 times the dosage of finasteride tablets (5 mg daily) produced significant median decreases of approximately 0 .5 mL (-25%) compared to placebo in ejaculate volume, but this was reversible after discontinuation of treatment. In the clinical studies with finasteride tablets, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicu lar pain in finasteride-treated patients were not different from those in patients treated with placebo . Controlled Clinical Trials and Long-Term Open Extension Studies for finasteride tablets 5 mg(finasteride 5 mg) and AVODART (dutasteride) in the Treat ment of Benign Prostatic H yperplasia In the finasteride tablets 5 mg Long-Term Efficacy and Safety Study (PLESS), a 4-year controlled clinical study, 3040 patients between the ages of 45 and 78 with symptomatic BPH and an enlarged prostate were evaluated for safety over a period of 4 years (1524 on finasteride tablets, 5 mg /day and 1516 on placebo). 3.7% (57 patients) treated with finasteride tablets 5 mg and 2.1% (32 patients) treated with placebo discontinued therapy as a result of adverse reactions related to se xual function, which are the most frequently reported adverse reactions. Table 2 presents the only clinical adverse react ions considered possibly, probably or definitely drug related by the investigator, for which the incidence on finasteride tablets 5 mg 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 impoten ce, decreased libido and ejaculation disorder. TABLE 2: Drug-Related Adverse Experiences for Finasteride tablets 5 mg BENIGN PROSTATIC HYPERPLASIA Year 1 (%) Years 2, 3 and 4* (%) Finasteride 5 mg Placebo Finasteride 5 mg 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 *Combined Years 2 to 4 N = 1524 and 1516, finasteride vs placebo, respectively The adverse experience profiles in the 1-year, pla cebo-controlled, Phase III BPH studies and the 5-year open extensions with finasteride tablets 5 mg and PLESS were similar. There is no evidence of increased sexual adverse experiences with i ncreased duration of treatment with finasteride tablets 5 mg. New reports of drug-related sexual adverse experiences decreased with duration of therapy. During the 4- to 6-year placebo- and comparator- controlled Medical Therapy of Prostatic Symptoms (MTOPS) study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride tablets but no cases in men not treated with finasteride tablets. 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 tablets. 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 w ith finasteride tablets, and 1 case of breast cancer in men treated with placebo. The relationship between long-t erm use of finasteride and male breast neoplasia is currently unknown. The PCPT trial was a 7-year randomized, double- blind, placebo-controlled trial that enrolled 18,882 healthy men ≥55 years of age with a normal digital rectal examination and a PSA ≤3.0 ng/mL. Men received either finasteride tablets 5 mg (finasteride 5 mg) or p lacebo daily. Patients were evaluated annually with PSA and digital rectal exams. Biopsies were performed f or elevated PSA, an abnormal digital rectal exam, or the end of study. The incidence of Gleason score 8 to 10 prostate cancer was higher in men treated with finasteride (1.8%) than in those treated with placebo (1.1%). In a 4-year placebo -controlled clinical trial with another 5 α-reductase inhibitor [AVODART (dutaster ide)], similar results for Gleason score 8 to 10 prostate cancer were observed (1% dutasteride vs 0.5% placebo). The clinical significance of these findings with respect to use of finasteride tablets by men is unknown. No clinical benefit has been demonstrated in patients with prostate cancer treated with finasteride tablets. Finasteride tablets is not approved to reduce the risk of developing prostate cancer. 6.2 Postmarketing Experience The following adverse reactions have been identified during post approval use of finasteride tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establi sh a causal relationship to drug exposure: Hypersensitivity Reaction: hypersensitivity reactions such as rash, pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face); Reproductive System: sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders; male infertility and/or poor seminal quality (normalization or improvement of seminal quality has been reported after discontinuation of finasteride); testicular pain. [ See Adverse Reactions (6.1).] Neoplasms: male breast cancer; Breast disorders: breast tenderness and enlargement; Nervous System/Psychiatric: depression