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AVODART is a brand name for Dutasteride, supplied as a capsule. 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.
5 mg capsule taken orally once a day. 4 mg capsule taken once daily. Administration AVODART® capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa.
(see WARNINGS AND PRECAUTIONS, Exposure of Women - Risk to Male Fetus and SPECIAL HANDLING INSTRUCTIONS). AVODART® may be taken with or without food (see WARNINGS AND PRECAUTIONS, Drug-Food Interactions). Although an improvement in symptoms may be observed after 3 months in some patients, it can take up to 6 months before a response to the treatment can be achieved (See CLINICAL TRIALS).
Renal Impairment The effect of renal impairment on dutasteride pharmacokinetics has not been studied. 5 mg dose of dutasteride is recovered in human urine, and no adjustment in dose is anticipated for patients with renal impairment.
Hepatic Impairment The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized and has a half-life of 3 to 5 weeks, caution should be used in the administration of dutasteride to patients with liver disease.
Missed Dose If a dose is missed the capsule can be taken at the next scheduled dose. Extra capsules taken for missed doses are not necessary. Page 16 of
Adverse Drug Reaction Overview Most adverse reactions were mild or moderate and generally resolved while on treatment in both the AVODART® and placebo groups. The most common adverse events leading to withdrawal in both treatment groups were associated with the reproductive system.
From the clinical trials described below in which AVODART® was administered alone or in combination with tamsulosin: The most common adverse reactions reported in subjects receiving AVODART® were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), and ejaculation disorders.
The most common adverse reactions reported in subjects receiving combination therapy (AVODART® plus tamsulosin) were impotence, decreased libido, breast disorders (including breast enlargement and tenderness), ejaculation disorders, and dizziness.
The percentages of subjects with ejaculation disorders, decrease libido and impotence were higher in the combination therapy group compared with either monotherapy groups. Study withdrawal due to adverse reactions occurred in 4% of subjects receiving AVODART®, 6% of subjects receiving combination therapy (AVODART® plus tamsulosin), 4% of subjects receiving tamsulosin and 3% of subjects receiving placebo.
The most common adverse reaction in all treatment arms leading to study withdrawal was impotence. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 5 mg daily doses of AVODART® in 3 identical 2 year, placebo-controlled, double blind, Phase 3 treatment studies, each with 2 year open-label extensions.
Serious Warnings and Precautions AVODART® is for use for men only.
Exposure of Women-Risk to Male Fetus:
Dutasteride is absorbed through the skin. Therefore, women who are pregnant or may be pregnant should not handle AVODART® capsules.
General Increased Risk of High-grade Prostate Cancer:
Prior to treatment with AVODART®, patients should be assessed thoroughly to rule out other urological diseases including prostate cancer. AVODART® may be associated with an increase in high grade prostate cancer. 0 ng/mL, taking AVODART® for 4 years, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (see ADVERSE REACTIONS).
At this time it is unknown how therapy with AVODART® might influence the progression of prostate cancer or affect high grade prostate cancer. No causal relationship between AVODART® and high grade prostate cancer has been established.
1%). 5 alpha-reductase inhibitors may increase the risk of development of high-grade prostate cancer. Whether the effect of 5 alpha-reductase inhibitors to reduce prostate volume, or study related factors, impacted the results of these studies has not been established.
See INDICATION AND CLINICAL USE and ADVERSE REACTIONS. Breast changes including breast enlargement, tenderness and cancer have been reported. Prescribers should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge (see ADVERSE REACTIONS).
Patients with a large residual urinary volume and/or severely diminished urinary flow may not be proper candidates for 5 alpha-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy. No study has been conducted to determine if AVODART® can be used for the control of BPH in asymptomatic patients.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Dutasteride in Canada.
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During the double blind treatment period, 2,167 male subjects were exposed to AVODART®, including 1,772 exposed for 1 year and 1,510 exposed for 2 years. When including the open label extensions, 1,009 male subjects were exposed to AVODART® for 3 years and 812 were exposed for 4 years.
The population was aged 47 to 94 years (mean age, 66 years) and greater than 90% Caucasian. Over the 2-year double-blind treatment period, 376 subjects (9% of each treatment group) were withdrawn from the studies due to adverse experiences, most commonly associated with the reproductive system, with similar findings during the 2- Page 9 of 46 year open-label extensions.
Table 1 summarizes clinical adverse reactions that were reported by the investigator as drug-related in at least 1% of subjects receiving AVODART® and at a higher incidence than subjects receiving placebo. 9% * A drug-related adverse event is one considered by the investigator to have a reasonable possibility of being caused by the study medication.
In assessing causality, investigators were asked to select from 1 of 2 options: reasonably related to study medication or unrelated to study medication. † Includes breast tenderness and breast enlargement. ** All subjects switched to open-label dutasteride for months 25 to 48.
†† These sexual adverse events are associated with dutasteride treatment (including monotherapy and combination with tamsulosin). These adverse events may persist after treatment discontinuation. The role of dutasteride in this persistence is unknown.
In BPH monotherapy clinical trials, providing 3,374 patient-years of exposure to AVODART®, there were 2 cases of breast cancer reported in AVODART®-treated patients, one after 10 weeks and one after 11 months of treatment and 1 case in a patient who received placebo.
In subsequent clinical trials in BPH and prostate cancer risk reduction providing 17,489 patient-years exposure to AVODART® and 5,027 patient years exposure to AVODART® and tamsulosin combination, there were no additional cases in any of the treatment groups.
The relationship between long term use of dutasteride and male breast cancer is unknown. The relationship between long-term use of Dutasteride and Leydig cell tumours of the testis, Hepatocellular adenomas, and the Gleason score (grade of malignancy) of prostate cancer in patients taking long term alpha-reductase inhibitors is currently unknown.
4 mg/day, n =1,610), AVODART® alone (n =1,623) or tamsulosin alone (n=1,611). Over the 4 years of treatment, 1,623 subjects received monotherapy with AVODART®; 1,611 subjects received monotherapy with Page 10 of 46 tamsulosin; and 1,610 subjects received combination therapy.
The population was aged 49 to 88 years (mean age 66 years) and 88% Caucasian. Table 2 summarizes adverse reactions reported in at least 1% of […]
The long-term (> 4 years) beneficial and adverse effects of AVODART® have not been established. , Inc. Used under license. Page 5 of 46 Cardiovascular In two 4-year clinical studies, the incidence of cardiac failure (a composite term of reported events, primarily cardiac failure and congestive cardiac failure) was higher among subjects taking the combination of AVODART® and an alpha-blocker, primarily tamsulosin, than it was among subjects not taking the combination.
07] compared with tamsulosin monotherapy. In these 2 studies, the incidence of cardiac failure was low ( 1%) and variable between the studies. No imbalance was observed in the incidence of cardiovascular adverse events overall in either study.
While no causal relationship between AVODART® (alone or in combination with an alpha- blocker) and cardiac failure has been established, patients with underlying risk factors for cardiovascular disease, including past or current cardiovascular conditions, advanced age, elevated resting heart rate, should be monitored for signs and symptoms of cardiac failure (see ADVERSE REACTIONS).
5 mg/day (n = 26) resulted in no clinically significant change compared with placebo (n = 23) in sex hormone binding globulin, estradiol, luteinizing hormone, follicle-stimulating hormone, thyroxine (free T4), and dehydroepiandrosterone.
05). 4% for TSH at 52 weeks. After stopping dutasteride for 24 weeks, the mean levels of testosterone and TSH had returned to baseline in the group of subjects with available data at the visit. 5 mg/day for 4 years, the median decrease in serum DHT was 94% at 1 year, 93% at 2 years, and 95% at both 3 and 4 years.
The median increase in serum testosterone was 19% at both 1 and 2 years, 26% at 3 years, and 22% at 4 years, but the mean and median levels remained within the physiologic range. In patients with BPH treated with dutasteride in a large Phase III trial, there was a median percent increase in luteinizing hormone of 12% at 6 months and 19% at both 12 and 24 months.
Hematologic Men treated with dutasteride should not donate blood until at least 6 months have passed following their last dose. The purpose of this deferred period is to prevent administration of dutasteride to a pregnant female transfusion recipient.
Hepatic The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolized and has a half-life of 3 to 5 weeks, caution should be used in the administration of dutasteride to patients with liver disease.
5 mg/day on semen characteristics were evaluated in normal volunteers aged 18 to 52 (n=27 dutasteride, n=23 placebo) throughout 52 weeks of treatment and 24 weeks of post treatment follow-up. At 52 weeks, the mean percent reduction from baseline in total sperm count, semen volume, and sperm motility were 23%, 26%, and 18%, respectively, in the dutasteride group when adjusted for changes from baseline in the placebo group.
Sperm concentration and sperm morphology […]