Finasteride (Page 3 of 4)

Adverse Reactions to Finasteride

Finasteride is generally well tolerated; adverse reactions usually have been mild and transient.

4-Year Placebo-Controlled Study

In a long-term efficacy and safety study, 1524 patients treated with finasteride and 1516 patients treated with placebo were evaluated for safety over a period of 4 years. The most frequently reported adverse reactions were related to sexual function. 3.7% (57 patients) treated with finasteride 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 was ≥1% and greater than placebo over the 4 years of the study. In years 2-4 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
Year 1 (%) Years 2,3 and 4* (%)
Finasteride Placebo Finasteride 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 2-4
N=1524 and 1516, finasteride vs placebo, respectively

Phase III Studies and 5-Year Open Extensions

The adverse experience profile in the 1-year, placebo-controlled, Phase III studies, the 5-year open extensions, and a long-term efficacy and safety study were similar.

Long-Term Data

There is no evidence of increased adverse experiences with increased duration of treatment with finasteride. New reports of drug-related sexual adverse experiences decreased with duration of therapy.

During a 4- to 6-year placebo and comparator controlled study that enrolled 3047 men, there were 4 cases of breast cancer in men treated with finasteride but no cases in men not treated with finasteride. During the 4-year, placebo-controlled a long-term efficacy and safety 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. The relationship between long-term use of finasteride and male breast neoplasia is currently unknown.

In a 7-year placebo-controlled trial that enrolled 18,882 healthy men, 9060 had prostate needle biopsy data available for analysis. In the finasteride group, 280 (6.4%) men had prostate cancer with Gleason scores of 7-10 detected on needle biopsy vs. 237 (5.1%) men in the placebo group. Of the total cases of prostate cancer diagnosed in this study, approximately 98% were classified as intracapsular (stage T1 or T2). The clinical significance of these findings is unknown. This information from the literature (Thompson IM, Goodman PJ, Tangen CM, et al. The influence of finasteride on the development of prostate cancer. N Engl J Med 2003;349:213-22) is provided for consideration by physicians when finasteride is used as indicated (see INDICATIONS AND USAGE). Finasteride is not approved to reduce the risk of developing prostate cancer.

Post-Marketing Experience

The following additional adverse effects have been reported in post-marketing experience:

– hypersensitivity reactions, including pruritus, urticaria, and swelling of the lips and face

– testicular pain.

OVERDOSAGE

Patients have received single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months without adverse effects. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.

Significant lethality was observed in male and female mice at single oral doses of 1500 mg/m2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/m2 (400 mg/kg) and 5900 mg/m2 (1000 mg/kg), respectively.

DOSAGE AND ADMINISTRATION

The recommended dose is 5 mg orally once a day.

Finasteride may be administered with or without meals. No dosage adjustment is necessary for patients with renal impairment or for the elderly (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

HOW SUPPLIED

Finasteride Tablets, USP 5 mg are blue, round, film-coated tablets, with “F5” on one side and image on the other.Available in:

Bottles of 30NDC 54868-5636-0
Bottles of 60NDC 54868-5636-2
Bottles of 90NDC 54868-5636-1

Store at 20 to 25°C (68 to 77°F) with excursions permitted between 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature].

Protect from light and keep container tightly closed.

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 the male fetus (see CONTRAINDICATIONS ; WARNINGS, EXPOSURE OF WOMEN — RISK TO MALE FETUS ; PRECAUTIONS, Pregnancy and HOW SUPPLIED).

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

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).

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

Manufactured by:
INTAS PHARMACEUTICALS LTD.
Plot No. 457, 458
Sarkhej-Bavla Highway
Matoda-382 210
Gujarat, India

Distributed by:
Actavis Totowa
990 Riverview Drive Totowa,
NJ 07512 USA

8569-01
01/07

Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146

SUPPLEMENTAL PATIENT MATERIAL

Patient Package Insert

PATIENT INFORMATION ABOUT FINASTERIDE TABLETS, USP 5 mg 8570-01
(fin-AS-tur-eyed)

Finasteride is for use by men only.

Please read this leaflet before you start taking finasteride. 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 when you start taking your medication and at regular checkups.

Why your doctor has prescribed finasteride

Your doctor has prescribed finasteride because you have a medical condition called benign prostatic hyperplasia or BPH. This occurs only in men.

What is BPH?

BPH is an enlargement of the prostate gland. After age 50, most men develop enlarged prostates. 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.

Treatment options for BPH

There are three main treatment options for symptoms of BPH:

  • Program of monitoring or “Watchful Waiting”. If a man has an enlarged prostate gland and no symptoms or if his symptoms do not bother him, he and his doctor may decide on a program of monitoring which would include regular checkups, instead of medication or surgery.

  • Medication. Your doctor may prescribe finasteride for BPH. See “What finasteride does” below.

  • Surgery. Some patients may need surgery. Your doctor can suggest several different surgical procedures for BPH. Which procedure is best depends on your symptoms and medical condition.

There are two main treatment options to reduce the risk of serious problems due to BPH:

  • Medication. Your doctor may prescribe finasteride for BPH. See “What finasteride does” below.

  • Surgery. Some patients may need surgery. Your doctor can suggest several different surgical procedures for BPH. Which procedure is best depends on your symptoms and medical condition.

What finasteride does

Finasteride lowers levels of a key hormone called DHT (dihydrotestosterone), which is a major 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 will help reduce the risk of the need for surgery. 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 for six (6) months or more to see whether it improves your symptoms.

  • Therapy with finasteride may reduce the need for surgery.

What you need to know while taking finasteride

  • You must see your doctor regularly. While taking finasteride, you must have regular checkups. Follow your doctor’s advice about when to have these checkups.

  • About side effects. Like all prescription drugs, finasteride may cause side effects. Side effects due to finasteride may include impotence (an inability to have an erection) or less desire for sex.
    Some men taking finasteride may have changes or problems with ejaculation, such as a decrease in the amount of semen released during sex. This decrease in the amount of semen does not appear to interfere with normal sexual function. In some cases these side effects went away while the patient continued to take finasteride.
    In addition, some men may have breast enlargement and/or tenderness. You should promptly report to your doctor any changes in your breasts such as lumps, pain or nipple discharge. Some men have reported allergic reactions such as rash, itching, hives, and swelling of the lips and face. Rarely, testicular pain has been reported.
    You should discuss side effects with your doctor before taking finasteride and anytime you think you are having a side effect.

  • Checking for prostate cancer. Your doctor has prescribed finasteride for symptomatic BPH and not for cancer — but a man can have BPH and prostate cancer at the same time.
    Doctors usually recommend that men be checked for prostate cancer once a year when they turn 50 (or 40 if a family member has had prostate cancer). These checks should continue while you take finasteride. Finasteride is not a treatment for prostate cancer.

  • About Prostate-Specific Antigen (PSA).
    Your doctor may have done a blood test called PSA. Finasteride can alter PSA values. For more information, talk to your doctor.

  • A warning about finasteride and pregnancy.
    Finasteride is for use by MEN only.
    Women who are or may potentially be pregnant must not use finasteride. They should also not handle crushed or broken tablets of finasteride.
    If a woman who is pregnant with a male baby absorbs the active ingredient in finasteride after oral use or through the skin, it may cause the male baby to be born with abnormalities of the sex organs.
    Finasteride tablets 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 comes into contact with the active ingredient in finasteride, a doctor should be consulted.
    Remember, these warnings apply only when the woman is pregnant or could potentially be pregnant.

How to take finasteride

Follow your doctor’s advice about how to take finasteride. You must take it every day. You may take it with or between meals. To avoid forgetting to take finasteride, it may be helpful to take it at the same time every day.

Do not share finasteride with anyone else; it was prescribed only for you.

Keep finasteride and all medicines out of the reach of children.

FOR MORE INFORMATION ABOUT ‘finasteride’ AND BPH, TALK WITH YOUR DOCTOR.

IN ADDITION, TALK TO YOUR PHARMACIST OR OTHER HEALTH CARE PROVIDER.

Manufactured by:
INTAS PHARMACEUTICALS LTD.
Plot No. 457, 458
Sarkhej-Bavla Highway
Matoda-382 210
Gujarat, India

Distributed by:
Actavis Totowa LLC
990 Riverview Drive Totowa, NJ 07512 USA

8570-01

01/07

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