Finasteride: Package Insert and Label Information

FINASTERIDE- finasteride tablet, film coated
Asclemed USA, Inc.

1 INDICATIONS & USAGE

Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY.
Efficacy in bitemporal recession has not been established. Finasteride tablets USP are not indicated for use in women.

2 DOSAGE & ADMINISTRATION

Finasteride tablets USP may be administered with or without meals.
The recommended dose of finasteride tablets USP is one tablet (1 mg) taken once daily.
In general, daily use for three months or more is necessary before benefit is observed. Continued use is recommended to sustain benefit, which should be re-evaluated periodically. Withdrawal of treatment leads to reversal of effect within 12 months.

3 DOSAGE FORMS & STRENGTHS

Finasteride tablets USP, 1 mg is brown color, round film coated tablets, debossed with ‘H’ on one side and ’36’ on other side.

4 CONTRAINDICATIONS


Finasteride tablets USP are contraindicated in the following:
• 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 5α-dihydrotestosterone (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 Warnings and Precautions (5.1), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.1).] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. • Hypersensitivity to any component of this medication.

5 WARNINGS AND PRECAUTIONS

5.1 Exposure of Women — Risk to Male Fetus

Finasteride tablets USP are not indicated for use in women. 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. [S ee Indications and Usage (1), Contraindications (4), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.1). ]

5.2 Effects on Prostate Specific Antigen (PSA)

In clinical studies with finasteride tablets USP in men 18 to 41 years of age, the mean value of serum prostate specific antigen (PSA) decreased from 0.7 ng/mL at baseline to 0.5 ng/mL at Month 12. Further, in clinical studies with finasteride tablets USP 5 mg when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Other studies with finasteride tablets USP 5 mg showed it may also cause decreases in serum PSA in the presence of prostate cancer. These findings should be taken into account for proper interpretation of serum PSA when evaluating men treated with finasteride. Any confirmed increase from the lowest PSA value while on finasteride tablets USP 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 to therapy with finasteride tablets USP may also affect PSA test results.

5.3 Increased Risk of High-Grade Prostate Cancer with 5-Reductase Inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA ≤3 ng/mL at baseline taking finasteride 5 mg/day (5 times the dose of finasteride tablets USP 1 mg) in the 7-year Prostate Cancer Prevention Trial (PCPT) had an increased risk of Gleason score 8 to 10 prostate 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 USP are not indicated for use in pediatric patients [ see Use in Specific Populations (8.4)].

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted 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 observed in clinical practice.
Clinical Studies for Finasteride Tablets USP 1 mg in the Treatment of Male Pattern Hair Loss
In three controlled clinical trials for finasteride tablets USP of 12-month duration, 1.4% of patients taking finasteride tablets USP (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 USP or placebo are presented in Table 1.

TABLE 1 Drug-Related Adverse Experiences for Finasteride Tablets USP, 1 mg in Year 1 (%) MALE PATTERN HAIR LOSS
Finasteride tablets USP N=945 Placebo N=934
Decreased Libido 1.8 1.3
Erectile Dysfunction 1.3 0.7
Ejaculation Disorder (Decreased Volume 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 USP 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 USP 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 USP.
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 USP (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 USP, the incidences for breast tenderness and enlargement, hypersensitivity reactions, and testicular 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 USP, 5 mg and AVODART (dutasteride) in the Treatment of Benign Prostatic Hyperplasia
In the finasteride tablets USP, 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 USP, 5 mg/day and 1516 on placebo). 3.7% (57 patients) treated with finasteride tablets USP, 5 mg 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, 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 impotence, decreased libido and ejaculation disorder.

TABLE 2 Drug-Related Adverse Experiences for finasteride tablets USP, 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, placebo-controlled, Phase III BPH studies and the 5-year open extensions with finasteride tablets USP, 5 mg and PLESS were similar.
There is no evidence of increased sexual adverse experiences with increased duration of treatment with finasteride tablets USP, 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 USP, 5 mg but no cases in men not treated with finasteride tablets USP, 5 mg. 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 USP, 5 mg.
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 finasteride tablets USP, 5 mg, and 1 case of breast cancer in men treated with placebo. The relationship between long-term 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 ng/mL. Men received either finasteride tablets USP, 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 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 5α-reductase inhibitor [AVODART (dutasteride)], 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 USP, 1 mg by men is unknown. No Clinical benefit has been demonstrated in patients with prostate cancer treated with finasteride tablets USP, 5 mg. Finasteride tablets USP, 5 mg are 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 USP. Because these reactions 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:
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

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