Elements for a Public Summary

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1 VI.2 VI.2.1 Elements for a Public Summary Overview of disease epidemiology Benign prostatic hyperplasia (BPH), also called benign prostatic hypertrophy or benign prostatic obstruction, is a condition in which the prostate gland is enlarged and not cancerous. BPH occurs in up to 50% of men by age 50, and the incidence increases with age; the greatest prevalence occurs among men ages 70 to 79 years. 22

2 In BPH, a proliferation of prostatic cells leads to an increase in prostate size. As a result, the urethra is compressed and this restricts the flow of urine from the bladder, commonly referred to as "obstruction". This interference with urine flow may cause uncomfortable symptoms such as urinary frequency, urinary urgency, night time urination (nocturia), intermittency, decreased stream and hesitancy, also known as lower urinary tract symptoms (LUTS) which represent the most common clinical manifestation of BPH. Prolonged obstructions may eventually lead to acute urinary retention (AUR), recurrent urinary tract infection (UTI), blood in the urine (hematuria), bladder stones (calculi), and poor kidney function (renal insufficiency). Benign prostatic hyperplasia is the most common prostate problem for men older than age 50. In 2010, as many as 14 million men in the United States had lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia. Worldwide, approximately 30 million men have symptoms related to BPH. The prevalence of BPH in white and African-American men is similar. However, BPH tends to be more severe and progressive in African-American men. Several factors have also been reported to be associated with an increased risk for BPH including religion, socioeconomic factors, sexual activity, vasectomy, alcohol use, cirrhosis, hypertension, smoking, diet, and obesity. However, there is no compelling evidence that any of these factors is associated with a greater risk for developing BPH. VI.2.2 Summary of treatment benefits There are several effective treatments for prostate gland enlargement, including medications, minimally invasive therapies and surgery. Medications commonly used to relieve obstructive symptoms of BPH include α1-receptor blockers and 5α-reductase inhibitors to reduce pressure on the urethra and allow for easier passage of urine. Dutasteride, which is a 5α-reductase inhibitor, inhibits the conversion of testosterone to dihydrotestosterone (DHT), the main mediator of BPH progression. The effect can be observed after 1-2 weeks of therapy (85% and 90% reduction, respectively), with reductions of 94% at 1 year and 93% at 2 years of therapy. This causes the prostate to decrease in size and slow the progress of prostate growth. Based on the results of a meta-analysis on randomized clinical trials in 6460 patients, dutasteride was found to be well-tolerated and highly effective in mitigating benign prostatic hyperplasia symptoms and reducing the size of enlarged prostate and the risks of acute urinary retention (AUR) and BPH-related surgery. VI.2.3 Unknowns relating to treatment benefits Dutasterine has not been studied in patients with liver or kidney disease. Younger patients have not been studied since BPH is a disease of older men. 23

3 VI.2.4 Summary of safety concerns Important identified risks What is known Preventability Reproductive systems: - Sexual adverse events of altered (decreased) libido, impotence, ejaculation disorder that may persist after drug discontinuation. - Breast disorders (enlargement and tenderness) Allergic reaction, including rash, pruritus, urticarial, localised oedema and angioedema Cardiac failure In clinical studies, some patients taking dutasteride experienced decreased sex drive, impotence and difficulty with ejaculation. Some patients also experienced enlarged or painful breasts. Allergic reaction, including rash, pruritus, urticarial, localised oedema and angioedema, has been reported in clinical studies and post-marketing experience as not known adverse reaction (the frequency cannot be estimated from the available data). In clinical studies, some patients experienced the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) which was higher among subjects taking the combination of [Product name] and an alpha blocker than in either monotherapy group. Depressed mood Depressed mood has been reported in post-marketing experience as a not known adverse reaction (the frequency cannot be estimated from the available data). [Product name] is contraindicated in patients with hypersensitivity to dutasteride, other 5-alpha reductase inhibitorst or any of the other excipients. Important potential risks Cardiovascular events other than cardiac failure What is known (Including reason why it is considered a potential risk) Based on available data there was no consistent evidence of a significant association between dutasteride therapy and the risk of cardiovascular adverse events. Male breast cancer Breast cancer has been reported in men taking dutasteride in clinical trials (see section 5.1) and during the post-marketing period. Physicians should instruct their patients to promptly report 24

4 High-grade prostate cancer Interference with formation of external male genitalia in the foetus What is known (Including reason why it is considered a potential risk) any changes in their breast tissue such as lumps or nipple discharge. Currently it is not clear if there is a causal relationship between the occurrence of male breast cancer and long term use of dutasteride. Results of one clinical study (the REDUCE study) in men at increased risk of prostate cancer revealed a higher of Gleason 8-10 prostate cancers in dutasteride treated men compared to placebo. The relationship between dutasteride and high grade prostate cancer is not clear. Men taking [Product name] should be regularly evaluated for prostate cancer risk including PSA testing. Dutasteride can be adsorbed through the skin and can therefore affect the normal development of the male baby. This is a particular risk in the first 16 weeks of pregnancy. It is advised that patients use condoms during sexual intercourse to prevent this exposure. Pregnant women should not touch dutasteride capsules. If pregnant woman or woman of childbearing potential comes in contact with leaking capsules, the contact area should be washed immediately with soap and water. Missing information Safety of dutasteride therapy in men with severe hepatic impairment Safety of dutasteride therapy in men with unstable medical conditions such as recent myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident; cancer; or uncontrolled diabetes or peptic ulcer disease. What is known The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied so caution should be used in patients with mild to moderate hepatic impairment. Because dutasteride is eliminated mainly through metabolism the plasma levels of dutasteride are expected to be elevated in these patients and the half-life of dutasteride be prolonged. In patients with severe hepatic impairment, the use of dutasteride is contraindicated. No specific data are currently available on the use of dutasteride in men with recent myocardia infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident; cancer; or uncontrolled diabetes or peptic ulcer disease. 25

5 VI.2.5 Summary of additional risk minimisation measures by safety concern All medicines have a Summary of product characteristics (SPC) which provides physicians, pharmacists and other health care professionals with details on how to use the medicine, the risks and recommendations for minimising them. An abbreviated version of this in lay language is provided in the form of the package leaflet (PL). The measures in these documents are known as routine risk minimisation measures. This medicine has no additional risk minimisation measures. VI.2.6 Planned post authorisation development plan Not applicable. VI.2.7 Summary of changes to the risk management plan over time Not applicable. 26

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