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BIO-FINASTERIDE is a brand name for Finasteride, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE........................................................................................... 3 CONTRAINDICATIONS ................................................................................................................ 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Bio-FINASTERIDE is well tolerated. Clinical Trial Adverse Drug Reactions In Finasteride Long-Term Efficacy and Safety Study, 1524 patients treated with finasteride 5 mg daily and 1516 patients treated with placebo were evaluated for safety over a period of 4 years.
3% (50 patients) treated with placebo. 1% (32 patients) treated with placebo discontinued therapy as a result of side effects related to sexual function, which were the most frequently reported side effects. Table 1 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. 5 * Combined years 2-4 The adverse experience profile in the one-year, placebo-controlled, Phase III studies and the five-year extensions, including 853 patients treated for 5 to 6 years, was similar to that reported in years 2-4 in Finasteride Long-Term Efficacy and Safety Study.
There is no evidence of increased adverse experiences with increased duration of treatment with finasteride. The incidence of new drug related sexual adverse experiences decreased with duration of treatment. Medical Therapy of Prostatic Symptoms (MTOPS) The MTOPS study compared finasteride 5 mg/day (n=768), doxazosin 4 or 8 mg/day (n=756), combination therapy of finasteride 5 mg/day and doxazosin 4 or 8 mg/day (n=786), and placebo (n=737).
In this study, the safety and tolerability profile of the combination therapy was generally consistent with the profiles of the individual components. The incidence of ejaculation disorder in Bio-FINASTERIDE (finasteride) Page 7 of 31 patients receiving combination therapy was comparable to the sum of incidences of this adverse experience for the two monotherapies.
The individual adverse effects that occurred more frequently in the combination group compared to either drug alone were asthenia, postural hypotension, peripheral edema, dizziness, decreased libido, rhinitis, abnormal ejaculation, impotence and abnormal sexual function (see Table 2).
Four patients in MTOPS reported the adverse experience breast cancer. Three of these patients were on finasteride only and one was on the combination therapy. During the four-year, placebo- controlled Finasteride Long-Term Efficacy and Safety Study, which enrolled 3040 men, there were 2 cases of breast cancer in the placebo treated men, but no cases were reported in men treated with finasteride.
General Patients with large residual urine volume and/or severely diminished urinary flow should be carefully monitored for obstructive uropathy. Bio-FINASTERIDE is not indicated for those patients who are candidates for immediate surgery.
No studies have been conducted to determine if finasteride can be used for the control of prostatic hyperplasia in asymptomatic patients. The long term (>10 years) beneficial and adverse effects of finasteride have not yet been established.
Prior to treatment with Bio-FINASTERIDE, the patient should undergo a thorough urological evaluation to determine the severity of the condition, and to exclude the need for immediate surgery or the possibility of carcinoma of the prostate.
Periodic follow-up evaluations should be performed to determine whether a clinical response has occurred. 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). Effects on PSA and Prostate Cancer Detection In clinical studies, finasteride reduced serum PSA concentration by approximately 50% within six 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 six 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 six months or more, PSA values should be doubled for comparison with normal ranges in untreated men.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The relationship between the long-term use of finasteride and male breast cancer is currently unknown. 1 *Doxazosin dose was achieved by weekly titration (1 to 2 to 4 to 8 mg). The final tolerated dose (4 mg or 8 mg) was administered at end-Week 4.
Only those patients tolerating at least 4 mg were kept on doxazosin. The majority of patients received the 8-mg dose over the duration of the study. 0 ng/mL. Men received either finasteride 5 mg or placebo daily. Patients were evaluated annually with PSA and digital rectal Bio-FINASTERIDE (finasteride) Page 8 of 31 exams.
Biopsies were performed for elevated PSA, an abnormal digital rectal exam, or the end of study. 1%) (See INDICATIONS AND CLINICAL USE and WARNINGS AND PRECAUTIONS). 5% placebo). No clinical benefit has been demonstrated in patients with prostate cancer treated with finasteride.
Laboratory Tests When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels are decreased in patients treated with finasteride (see WARNINGS AND PRECAUTIONS, Effects on PSA and Prostate Cancer Detection).
In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre- treatment value. Therefore, in typical patients treated with finasteride for six […]
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. 1%). 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. Prior to initiating therapy with finasteride, appropriate evaluation should be conducted to rule out other urological conditions, including prostate cancer that might mimic BPH.
Special Populations Pregnant and Nursing Women:
Bio-FINASTERIDE is contraindicated for use in women when they are or may potentially be pregnant (see CONTRAINDICATIONS). Because of the ability of Type II 5α-reductase inhibitors such as finasteride to inhibit conversion of testosterone to dihydrotestosterone, finasteride may cause abnormalities of the external genitalia of a male fetus when administered to a pregnant woman.
It is not known whether finasteride is excreted in human milk. In female rats, low doses of finasteride administered during pregnancy have produced abnormalities of the external genitalia in male offspring. Therefore, if this drug is used during pregnancy or if pregnancy occurs while taking or exposed to this drug, the pregnant woman should be apprised of the potential hazard to the male fetus (see TOXICOLOGY – Developmental Studies).
Exposure to Finasteride – Risk to Male Fetus:
Women should not handle crushed or broken tablets of Bio-FINASTERIDE when they are 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, Pregnant and Nursing Women).
Bio-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.
Pediatrics:
Bio-FINASTERIDE is not indicated for use in children. Safety and effectiveness in children have not been established. Monitoring and Laboratory Tests Effect on Levels of PSA Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age.
When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with Bio-FINASTERIDE. ∗ All other trademarks are the property of their respective owners. Bio-FINASTERIDE (finasteride) Page 6 of