Finasteride

Finasteride is part of a family of drugs called 5-alpha reductase inhibitors. These drugs work by blocking the activity of 5-alpha reductase, which is an enzyme that converts testosterone to dihydrotestosterone (DHT). DHT is a potent androgen (male sex hormone). It causes male pattern baldness (aka androgenetic alopecia) in men who are genetically predisposed to it, growth of the prostate leading to benign prostatic hyperplasia (BPH), and lower urinary tract symptoms (LUTS). Using 5-alpha reductase inhibitors to block this enzyme can slow or reverse hair loss and shrink the prostate over time.

Finasteride is used in the 1 mg dose to treat male pattern baldness and the 5 mg dose to treat symptoms of BPH. Finasteride works better if it is started earlier in the hair loss process. This is because there comes a time in the balding process when permanent changes in the scalp take place and prevent any hair regrowth (the specific point in time varies per person). However, even if that point as been reached, finasteride is still effective at preventing further hair loss. Research has shown that finasteride prevented further hair loss in 83% of men who took it for 2 years and 66% of men had some hair regrowth.

Propecia is the original brand name for 1 mg finasteride tablets for the treatment of male pattern hair loss. Most people who say they use Propecia today are actually taking generic finasteride 1 mg tablets, which have the same active ingredient as Propecia. The FDA requires that generic drugs demonstrate bioequivalence to the brand name drug, which means they act the same way in the body and are expected to produce the same effects as the original brand name drug.

Finasteride works by blocking 5-alpha reductase, an enzyme that converts testosterone to DHT. DHT is the hormone responsible for male pattern baldness in people who are genetically susceptible to it. By reducing levels of DHT, finasteride can slow or stop hair loss and even regrow hair in some cases.

• Take finasteride exactly as your healthcare provider tells you to take it.

• You may take finasteride with or without food.

• If you forget to take finasteride, do not take an extra tablet. Just take the next tablet as usual.

• Finasteride will not work faster or better if you take it more than once a day.

Short answer is yes. The same study from above that summarized the findings of 3 studies that evaluated the effects of finasteride showed that some men in the finasteride group has hair regrowth. The authors noted, “Based on standardized clinical photography, the chances of mild to moderate visible regrowth are 61% on the vertex (with an additional 5% achieving great visible regrowth) after 2 years and 37% on the frontal area after 1 year.” In the 2 studies done on hair loss at the crown of the head, 72% of men had further hair loss after 2 years. For clarity, vertex is the crown of the head and frontal area is the frontal or receding hairline.

The most common side effects of finasteride include:

• decrease in sex drive

• trouble getting or keeping an erection

• a decrease in the amount of semen

Important safety information for finasteride:

Finasteride is for use by MEN ONLY and should NOT be used by women or children.

Read this Important Safety 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.

What should I tell my healthcare provider before taking finasteride?

Before taking finasteride, tell your healthcare provider if you:

• have any other medical conditions, including problems with your prostate or liver

• Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Who should not take finasteride? Do not take finasteride if you have ever had an allergic reaction to any of its ingredients. Finasteride should not be used by women who are or may be pregnant or those who may become pregnant, and therefore is typically not prescribed to pre-menopausal women. It also should not be used while breastfeeding. Finasteride is not recommended for use in infants or children. If you have a history of liver disease, you should not use finasteride. Finasteride can affect the levels of a substance called PSA in your bloodstream, which is used as a marker to detect or monitor prostate cancer. Therefore you should tell your healthcare provider if you are taking this medication, especially if you have a history of prostate cancer. If you have a history of benign prostatic hyperplasia (BPH) with intermittent urinary tract obstruction, a healthcare provider may monitor you closely if you are being treated with this medication.

Drug interactions Finasteride and a dietary supplement known as Saw Palmetto (Serenoa repens) both have similar effects in the body (and may both be recommended for use in people with benign prostatic hyperplasia BPH), so their effects may be compounded when used together. Before starting treatment with finasteride, let your healthcare provider know about any medications or supplements you’re taking.

Side effects

What are the possible side effects of finasteride?

• 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.

The most common side effects of finasteride include:

• decrease in sex drive

• trouble getting or keeping an erection

• a decrease in the amount of semen

Finasteride serious side effects Serious side effects from finasteride when taken as directed are typically rare. There is some evidence that finasteride can increase the risk of breast cancer. It can also cause angioedema (a reaction that causes swelling in the face, eyes, and throat). Women who are pregnant, nursing, or may become pregnant should not use finasteride or come in contact with broken or crushed finasteride tablets. When used during pregnancy it can cause significant harm to the developing fetus.

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.

Finasteride warnings Finasteride may affect your ability to get or maintain an erection (erectile dysfunction). It can also affect your libido or reduce the volume of your ejaculation. There are some reports of testicular pain when using finasteride. When using this medication, let your healthcare provider know if you are experiencing new-onset or worsening depression.

Women who are pregnant, nursing, or may become pregnant should not use finasteride and should not touch broken tablets. When used during pregnancy, finasteride can cause significant harm to the developing fetus.

If you are experiencing a medical emergency, call 911 or seek immediate medical attention.

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.

You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the full Prescribing Information for complete safety information.

Oral finasteride 1 mg is one of two FDA-approved treatments for male pattern hair loss, the other one being topical minoxidil 2% or 5%. Since oral finasteride has been shown to cause sexual side effects in a small number of men (3.8% of men who took finasteride vs 2.1% of men who took placebo in phase III clinical trials for finasteride), researchers have been interested in whether topical finasteride applied to the scalp may be effective in treating male pattern hair loss with a lower potential for side effects.

A 2018 systematic review of the results of seven different studies concluded that topical finasteride is effective for the treatment of male pattern hair loss but also lowers plasma (blood) DHT levels which can lead to undesired side effects like low libido. Still, it appears that the incidence of side effects was lower with topical finasteride than oral finasteride. Also, some researchers found that plasma DHT levels were only minimally decreased with topical finasteride.

At this time, topical finasteride is not FDA-approved for the treatment of male pattern hair loss and must be specially compounded by a compounding pharmacy and requires a doctor’s prescription. For this reason, compounded topical finasteride is not available through Roman.