Prescription Drug Information: Finasteride (Page 4 of 5)

14.2 Combination with Alpha-Blocker Therapy

The Medical Therapy of Prostatic Symptoms (MTOPS) Trial was a double-blind, randomized, placebo-controlled, multicenter, 4- to 6-year study (average 5 years) in 3047 men with symptomatic BPH, who were randomized to receive finasteride tablets USP, 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), the combination of finasteride tablets USP, 5 mg/day and doxazosin 4 or 8 mg/day (n=786), or placebo (n=737). All participants underwent weekly titration of doxazosin (or its placebo) from 1 to 2 to 4 to 8 mg/day. Only those who tolerated the 4 or 8 mg dose level were kept on doxazosin (or its placebo) in the study. The participant’s final tolerated dose (either 4 mg or 8 mg) was administered beginning at end-Week 4. The final doxazosin dose was administered once per day, at bedtime.

The mean patient age at randomization was 62.6 years (±7.3 years). Patients were Caucasian (82%), African American (9%), Hispanic (7%), Asian (1%) or Native American (<1%). The mean duration of BPH symptoms was 4.7 years (±4.6 years). Patients had moderate to severe BPH symptoms at baseline with a mean AUA symptom score of approximately 17 out of 35 points. Mean maximum urinary flow rate was 10.5 mL/sec (±2.6 mL/sec). The mean prostate volume as measured by transrectal ultrasound was 36.3 mL (±20.1 mL). Prostate volume was ≤20 mL in 16% of patients, ≥50 mL in 18% of patients and between 21 and 49 mL in 66% of patients.

The primary endpoint was a composite measure of the first occurrence of any of the following five outcomes: a ≥4 point confirmed increase from baseline in symptom score, acute urinary retention, BPH-related renal insufficiency (creatinine rise), recurrent urinary tract infections or urosepsis, or incontinence. Compared to placebo, treatment with finasteride tablets USP, doxazosin, or combination therapy resulted in a reduction in the risk of experiencing one of these five outcome events by 34% (p=0.002), 39% (p<0.001), and 67% (p<0.001), respectively. Combination therapy resulted in a significant reduction in the risk of the primary endpoint compared to treatment with finasteride tablets USP alone (49%; p≤0.001) or doxazosin alone (46%; p≤0.001). (See Table 6.)

Table 6 Count and Percent Incidence of Primary Outcome Events by Treatment Group in MTOPS

Treatment Group
Placebo N=737 Doxazosin N=756 Finasteride N=768 Combination N=786 Total N=3047
Event N (%) N (%) N (%) N (%) N (%)
AUA 4-point rise 100 (13.6) 59 (7.8) 74 (9.6) 41 (5.2) 274 (9.0)
Acute urinary retention 18 (2.4) 13 (1.7) 6 (0.8) 4 (0.5) 41 (1.3)
Incontinence 8 (1.1) 11 (1.5) 9 (1.2) 3(0.4) 31 (1.0)
Recurrent UTI/urosepsis 2 (0.3) 2 (0.3) 0 (0.0) 1 (0.1) 5 (0.2)
Creatinine rise 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0)
Total Events 128 (17.4) 85 (11.2) 89 (11.6) 49 (6.2) 351 (11.5)

The majority of the events (274 out of 351; 78%) was a confirmed ≥4 point increase in symptom score, referred to as symptom score progression. The risk of symptom score progression was reduced by 30% (p=0.016), 46% (p<0.001), and 64% (p<0.001) in patients treated with finasteride tablets USP, doxazosin, or the combination, respectively, compared to patients treated with placebo (see Figure 4). Combination therapy significantly reduced the risk of symptom score progression compared to the effect of finasteride tablets USP alone (p<0.001) and compared to doxazosin alone (p=0.037).

Figure 4 Cumulative Incidence of a 4-Point Rise in AUA Symptom Score by Treatment Group

figure4
(click image for full-size original)

Treatment with finasteride tablets USP, doxazosin or the combination of finasteride tablets USP with doxazosin, reduced the mean symptom score from baseline at year 4. Table 7 provides the mean change from baseline for AUA symptom score by treatment group for patients who remained on therapy for four years.

Table 7 Change From Baseline in AUA Symptom Score by Treatment Group at Year 4 in MTOPS

PlaceboN=534 DoxazosinN=582 FinasterideN=565 Combination N=598
Baseline Mean (SD) 16.8 (6.0) 17.0 (5.9) 17.1 (6.0) 16.8 (5.8)
Mean Change AUA Symptom Score (SD) -4.9 (5.8) -6.6 (6.1) -5.6 (5.9) -7.4 (6.3)
Comparison to Placebo (95% CI) -1.8(-2.5, -1.1) -0.7(-1.4, 0.0) -2.5(-3.2, -1.8)
Comparison to Doxazosin alone (95% CI) -0.7(-1.4, 0.0)
Comparison to Finasteride alone (95% CI) -1.8(-2.5, -1.1)

The results of MTOPS are consistent with the findings of the 4-year, placebo-controlled study long-term efficacy and safety study [see Clinical Studies (14.1)] in that treatment with finasteride tablets USP reduces the risk of acute urinary retention and the need for BPH-related surgery. In MTOPS, the risk of developing acute urinary retention was reduced by 67% in patients treated with finasteride tablets USP compared to patients treated with placebo (0.8% for finasteride tablets USP and 2.4% for placebo). Also, the risk of requiring BPH-related invasive therapy was reduced by 64% in patients treated with finasteride tablets USP compared to patients treated with placebo (2.0% for finasteride tablets USP and 5.4% for placebo).

14.3 Summary of Clinical Studies

The data from these studies, showing improvement in BPH-related symptoms, reduction in treatment failure (BPH-related urological events), increased maximum urinary flow rates, and decreasing prostate volume, suggest that finasteride tablets USP arrests the disease process of BPH in men with an enlarged prostate.

16 HOW SUPPLIED/STORAGE AND HANDLING

Finasteride tablets USP, 5 mg are blue color, round film coated tablets, debossed with ‘H’ on one side ‘37’ on other side. They are supplied as follows:

Bottles of 90 NDC 33261-833-90

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and keep container tightly closed.

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 [see Warnings and Precautions (5.3), Use in Specific Populations (8.1) and Patient Counseling Information (17.2)].

17 PATIENT COUNSELING INFORMATION

[See FDA-Approved Patient Labeling (Patient Information) .]

17.1 Increased Risk of High-Grade Prostate Cancer

Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, including finasteride tablets USP, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Indications and Usage (1.3), Warnings and Precautions (5.2), and Adverse Reactions (6.1)].

17.2 Exposure of Women – Risk to Male Fetus

Physicians should inform patients that women who are pregnant or may potentially be pregnant should not handle crushed or broken finasteride tablets USP because of the possibility of absorption of finasteride and the subsequent potential risk to the 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. If a woman who is pregnant or may potentially be pregnant comes in contact with crushed or broken finasteride tablets USP, the contact area should be washed immediately with soap and water [see Contraindications (4), Warnings and Precautions (5.4), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

17.3 Additional Instructions

Physicians should inform patients that the volume of ejaculate may be decreased in some patients during treatment with finasteride tablets USP. This decrease does not appear to interfere with normal sexual function. However, impotence and decreased libido may occur in patients treated with finasteride tablets USP [see Adverse Reactions (6.1)].

Physicians should instruct their patients to promptly report any changes in their breasts such as lumps, pain or nipple discharge. Breast changes including breast enlargement, tenderness and neoplasm have been reported [see Adverse Reactions (6.1)].

Physicians should instruct their patients to read the patient package insert before starting therapy with finasteride tablets USP and to reread it each time the prescription is renewed so that they are aware of current information for patients regarding finasteride tablets USP.

Finasteride Tablets USP

Patient Information about Finasteride Tablets USP

(fin-AS-tur-eyed)

Finasteride Tablets USP are for use by men only.

Please read this leaflet before you start taking finasteride tablets USP. Also, read it each time you renew your prescription, just in case anything has changed. Remember, this leaflet does not take the place of careful discussions with your doctor. You and your doctor should discuss finasteride tablets USP when you start taking your medication and at regular checkups.

What are finasteride tablets USP?

Finasteride tablets USP is a medication used to treat symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Finasteride tablets USP may also be used to reduce the need for surgery related to BPH in men with an enlarged prostate.

Finasteride tablets USP may be prescribed along with another medicine, an alpha-blocker called doxazosin, to help you better manage your BPH symptoms.

Who should NOT take finasteride tablets USP?

Finasteride tablets USP are for use by MEN only.

Do Not Take finasteride tablets USP if you are:

  • a woman who is pregnant or may potentially be pregnant. Finasteride tablets USP may harm your unborn baby. Do not touch or handle crushed or broken finasteride tablets USP (see “A warning about finasteride tablets USP and pregnancy”).
  • allergic to finasteride or any of the ingredients in finasteride tablets USP. See the end of this leaflet for a complete list of ingredients in finasteride tablets USP.

A warning about finasteride tablets USP and pregnancy:

Women who are or may potentially be pregnant must not use finasteride tablets USP. They should also not handle crushed or broken tablets of finasteride tablets USP. Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

If a woman who is pregnant with a male baby absorbs the active ingredient in finasteride tablets USP after oral use or through the skin, it may cause the male baby to be born with abnormalities of the sex organs. If a woman who is pregnant comes into contact with the active ingredient in finasteride tablets USP, a doctor should be consulted.

How should I take finasteride tablets USP?

Follow your doctor’s instruction.

  • Take one tablet by mouth each day. To avoid forgetting to take finasteride tablets USP, you can take it at the same time every day.
  • If you forget to take finasteride tablets USP, do not take an extra tablet. Just take the next tablet as usual.
  • You may take finasteride tablets USP with or without food.
  • Do not share finasteride tablets USP with anyone else; it was prescribed only for you.

What are the possible side effects of finasteride tablets USP?

Finasteride tablets USP may increase the chance of a more serious form of prostate cancer.

The most common side effects of finasteride tablets USP include:

  • trouble getting or keeping an erection (impotence)
  • decrease in sex drive
  • decreased volume of ejaculate
  • ejaculation disorders
  • enlarged or painful breast. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge.

The following have been reported in general use with finasteride tablets USP and/or finasteride at lower doses:

  • allergic reactions, including rash, itching, hives, and swelling of the lips and face
  • rarely, some men may have testicular pain
  • trouble getting or keeping an erection that continued after stopping the medication
  • male infertility and/or poor quality of semen. Improvement in the quality of semen has been reported after stopping the medication.
  • depression
  • decrease in sex drive that continued after stopping the medication
  • in rare cases, male breast cancer has been reported.

In addition, the following have been reported in general use with finasteride tablets USP:

  • allergic reactions, including rash, itching, hives, and swelling of the lips and face
  • rarely, some men may have testicular pain
  • in rare cases, male breast cancer has been reported.

You should discuss side effects with your doctor before taking finasteride tablets USP and anytime you think you are having a side effect. These are not all the possible side effects with finasteride tablets USP. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at: 1-800-FDA-1088.

What you need to know while taking finasteride tablets USP:

  • You should see your doctor regularly while taking finasteride tablets USP. Follow your doctor’s advice about when to have these checkups.
  • Checking for prostate cancer. Your doctor has prescribed finasteride tablets USP for BPH and not for treatment of prostate cancer — but a man can have BPH and prostate cancer at the same time.Your doctor may continue checking for prostate cancer should continue while you take finasteride tablets USP.
  • About Prostate-Specific Antigen (PSA). Your doctor may have done a blood test called PSA for the screening of prostate cancer. Because finasteride tablets USP decreases PSA levels, you should tell your doctor(s) that you are taking finasteride tablets USP. Changes in PSA levels will need to be evaluated by your doctor(s). 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. You should also tell your doctor if you have not been taking finasteride tablets USP as prescribed because this may affect the PSA test results. For more information, talk to your doctor.

How should I store finasteride tablets USP?

  • Store finasteride tablets USP in a dry place at room temperature.
  • Keep finasteride tablets USP in the original container and keep the container closed.

Finasteride tablets USP are coated and will prevent contact with the active ingredient during normal handling, provided that the tablets are not broken or crushed.

Keep finasteride tablets USP and all medications out of the reach of children.

Do not give your finasteride tablets USP to anyone else. It has been prescribed only for you. For more information call 1-888-375-3784.

What are the ingredients in finasteride tablets USP?

Active ingredients: finasteride USP

Inactive ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, docusate sodium, magnesium stearate, opadry blue (FD&C blue #2 aluminium lake, hypromellose, talc, titanium dioxide, yellow iron oxide).

What is BPH?

BPH is an enlargement of the prostate gland. The prostate is located below the bladder. As the prostate enlarges, it may slowly restrict the flow of urine. This can lead to symptoms such as:

  • a weak or interrupted urinary stream
  • a feeling that you cannot empty your bladder completely
  • a feeling of delay or hesitation when you start to urinate
  • a need to urinate often, especially at night
  • a feeling that you must urinate right away.

In some men, BPH can lead to serious problems, including urinary tract infections, as well as the need for surgery

What finasteride tablets USP does:

Finasteride tablets USP lowers levels of a hormone called DHT (dihydrotestosterone), which is a cause of prostate growth. Lowering DHT leads to shrinkage of the enlarged prostate gland in most men. This can lead to gradual improvement in urine flow and symptoms over the next several months. Finasteride tablets USP will help reduce the need for surgery related to an enlarged prostate. However, since each case of BPH is different, you should know that:

  • Even though the prostate shrinks, you may NOT notice an improvement in urine flow or symptoms.
  • You may need to take finasteride tablets USP for six (6) months or more to see whether it improves your symptoms.
  • Therapy with finasteride tablets USP may reduce the need for surgery for an enlarged prostate.

To reorder additional Patient Information Leaflets, contact Dr. Reddy’s Customer Service at 1-866-733-3952.

Rx Only

Manufactured by

Hetero Labs Limited

Jeedimetla,

Hyderabad — 500 055, INDIA

Manufactured for

Dr. Reddy’s Laboratories Limited

Bachupally — 500 090, INDIA

Repackaged By :
Aidarex Pharmaceuticals LLC,Corona, CA 92880

Revised:October 2012

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