Finasteride

Finasteride tablets, USP are for use by MEN ONLY and should NOT be used by women or children. Read this Patient Information before you start taking finasteride and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.

Finasteride is a prescription medicine used for the treatment of male pattern hair loss (androgenetic alopecia).

It is not known if finasteride works for a receding hairline on either side of and above your forehead (temporal area).

Finasteride tablets may be administered with or without meals. The recommended dose of finasteride 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.

Exposure of Women — Risk to Male Fetus
Finasteride tablets are 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.

Effects on Prostate Specific Antigen (PSA)
In clinical studies with 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 baseline to 0.5 ng/mL at Month 12. Further, in clinical studies with finasteride, 5 mg when used in older men who have benign prostatic hyperplasia (BPH), PSA levels are decreased by approximately 50%. Other studies with finasteride 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 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 may also affect PSA test results.

Increased Risk of High-Grade Prostate Cancer with 5α-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) 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%). Similar results were observed in a 4-year placebo-controlled clinical trial with another 5α-reductase inhibitor (dutasteride) (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.

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. 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.

Decrease in your blood Prostate Specific Antigen (PSA) levels. Finasteride can affect a blood test called PSA (Prostate-Specific Antigen) for the screening of prostate cancer. If you have a PSA test done you should tell your healthcare provider that you are taking finasteride because finasteride decreases PSA levels. Changes in PSA levels will need to be evaluated by your healthcare provider. Any increase in follow-up PSA levels from their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal range for men not taking finasteride. You should also tell your healthcare provider if you have not been taking finasteride as prescribed because this may affect the PSA test results. For more information, talk to your healthcare provider.

There may be an increased risk of a more serious form of prostate cancer in men taking finasteride at 5 times the dose of finasteride.

Common Side Effects

• decrease in sex drive
• trouble getting or keeping an erection
• a decrease in the amount of semen

The following have been reported in general use with finasteride:

• breast tenderness and enlargement. Tell your healthcare provider about any changes in your breasts such as lumps, pain or nipple discharge
• depression
• decrease in sex drive that continued after stopping the medication
• allergic reactions including rash, itching, hives and swelling of the lips, tongue, throat, and face
• problems with ejaculation that continued after stopping medication
• testicular pain
• difficulty in achieving an erection that continued after stopping the medication
• male infertility and/or poor quality of semen
• in rare cases, male breast cancer

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of finasteride. For more information, ask your healthcare provider or pharmacist.

Please read the Patient Information in the accompanying Full Prescribing Information.

Finasteride is not indicated for use in pediatric patients.