Avorna Special Precautions

General: Lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with AVORNA. Patients with a large residual urinary volume and/or severely diminished urinary flow may not be good candidates for 5α-reductase inhibitor therapy and should be carefully monitored for obstructive uropathy.
Blood donation: Men being 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.
Prostate cancer: Men taking AVORNA should be regularly evaluated for prostate cancer risk including PSA testing.
Prostate-specific antigen (PSA): Serum prostate-specific antigen (PSA) concentration is an important component of the screening process to detect prostate cancer.
Dutasteride causes a decrease in mean serum PSA levels by approximately 50% after 6 months of treatment.
Patients receiving AVORNA should have a new PSA baseline established after 6 months of treatment with AVORNA. It is recommended to monitor PSA values regularly thereafter. Any confirmed increase from lowest PSA level while on AVORNA may signal the presence of prostate cancer or non-compliance to therapy with AVORNA and should be carefully evaluated, even if those values are still within the normal range for men not taking a 5-ARI. In the interpretation of a PSA value for a patient taking AVORNA, previous PSA values should be sought for comparison.
Treatment with AVORNA does not interfere with the use of PSA as a tool to assist in the diagnosis of prostate cancer after a new baseline has been established.
Total serum PSA levels return to baseline within 6 months of discontinuing treatment.
The ratio of free to total PSA remains constant even under the influence of AVORNA. If clinicians elect to use percent-free PSA as an aid in the detection of prostate cancer in men undergoing AVORNA therapy, no adjustment to its value is necessary.
Digital rectal examination, as well as other evaluations for prostate cancer, should be performed on patients prior to initiating therapy with AVORNA and periodically thereafter.
Cardiovascular adverse events: 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 dutasteride and an alpha blocker, primarily tamsulosin, than not taking the combination. No causal relationship between dutasteride (alone or in combination with an alpha blocker) and cardiac failure has been established.
Breast cancer: There have been rare reports of male breast cancer reported in men taking dutasteride. However, epidemiological studies showed no increase in the risk of developing male breast cancer with the use of 5-ARIs. Prescribers should instruct their patients to promptly report any changes in their breast tissue such as lumps or nipple discharge.
Leaking capsules: Dutasteride is absorbed through the skin, therefore women, children and adolescents must avoid contact with leaking capsules. If contact is made with leaking capsules the contact area should be washed immediately with soap and water.
Hepatic impairment: The effect of hepatic impairment on dutasteride pharmacokinetics has not been studied. Because dutasteride is extensively metabolised and has a half-life of 3 to 5 weeks, caution should be used in the administration of dutasteride to patients with liver disease.
Increased Risk of High-Grade Prostate Cancer: In men aged 50 to 75 years with a prior negative biopsy for prostate cancer and a baseline PSA between 2.5 ng/mL and 10.0 ng/mL taking AVODART in the 4-year Reduction by Dutasteride of Prostate Cancer Events (REDUCE) trial, there was an increased incidence of Gleason score 8-10 prostate cancer compared with men taking placebo (AVODART 1.0% versus placebo 0.5%). In a 7-year placebo controlled clinical trial with another 5-alpha reductase inhibitor (finasteride 5 mg, PROSCAR), similar results for Gleason score 8-10 prostate cancer were observed (finasteride 1.8% versus placebo 1.1%).
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.
Effects on Ability to Drive and Use Machines: Based on the pharmacokinetics and pharmacodynamic properties of dutasteride, treatment with dutasteride would not be expected to interfere with the ability to drive or operate machinery.