Finasteride

FINASTERIDE- finasteride tablet, film coated
Mylan Institutional Inc.

1 INDICATIONS AND USAGE

1.1 Monotherapy

Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

  • Improve symptoms
  • Reduce the risk of the need for surgery including transurethral resection of the prostate (TURP) and prostatectomy.

1.2 Combination with Alpha-Blocker

Finasteride tablets administered in combination with the alpha-blocker doxazosin are indicated to reduce the risk of symptomatic progression of BPH (a confirmed ≥ 4 point increase in American Urological Association (AUA) symptom score).

1.3 Limitations of Use

Finasteride tablets are not approved for the prevention of prostate cancer.

2 DOSAGE AND ADMINISTRATION

Finasteride tablets may be administered with or without meals.

2.1 Monotherapy

The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day [see Clinical Studies (14.1)].

2.2 Combination with Alpha-Blocker

The recommended dose of finasteride tablets is one tablet (5 mg) taken once a day in combination with the alpha-blocker doxazosin [see Clinical Studies (14.2)].

3 DOSAGE FORMS AND STRENGTHS

The 5 mg tablets are white film-coated, round, unscored tablets debossed with M on one side of the tablet and 151 on the other side.

4 CONTRAINDICATIONS

Finasteride tablets are contraindicated in the following:

  • Hypersensitivity to any component of this medication.
  • 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 also Warnings and Precautions (5.3), Use in Specific Populations (8.1), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2).] In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring.

5 WARNINGS AND PRECAUTIONS

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

In clinical studies, finasteride reduced serum PSA concentration by approximately 50% within 6 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 finasteride, a new PSA baseline should be established at least 6 months after starting treatment and PSA monitored periodically thereafter. Any confirmed increase from the lowest PSA value while on finasteride 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 finasteride therapy may also affect PSA test results. To interpret an isolated PSA value in patients treated with finasteride for 6 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 finasteride.

Finasteride 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 finasteride. If clinicians elect to use percent free PSA as an aid in the detection of prostate cancer in men undergoing finasteride 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 ng/mL at baseline taking finasteride 5 mg/day 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 Indications and Usage (1.3) and 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.

5.3 Exposure of Women — Risk to Male Fetus

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 Contraindications (4), Use in Specific Populations (8.1), Clinical Pharmacology (12.3), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2).]

5.4 Pediatric Patients and Women

Finasteride is not indicated for use in pediatric patients [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)] or women [see also Warnings and Precautions (5.3), Use in Specific Populations (8.1), Clinical Pharmacology (12.3), How Supplied/Storage and Handling (16) and Patient Counseling Information (17.2)].

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