s should not be handled by women who are pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus [see Warnings and Precautions (5.6)].
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Patient Information)
17.1 Orthostatic Hypotension
Physicians should inform patients about the possible occurrence of symptoms related to orthostatic hypotension, such as dizziness and vertigo, and the potential risk of syncope when taking JALYN. Patients starting treatment with JALYN should be cautioned to avoid situations where injury could result should syncope occur (e.g., driving, operating machinery, performing hazardous tasks). Patients should sit or lie down at the first signs of orthostatic hypotension [see Warnings and Precautions (5.1)].
17.2 PSA Monitoring
Physicians should inform patients that JALYN reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with JALYN may signal the presence of prostate cancer and should be eva luated by a healthcare provider [see Warnings and Precautions (5.3)].
17.3 Risk of High-grade Prostate Cancer
Physicians should inform patients that there was an increase in high-grade prostate cancer in men treated with 5 alpha-reductase inhibitors (which are indicated for BPH treatment), including dutasteride, which is a component of JALYN, compared with those treated with placebo in studies looking at the use of these drugs to reduce the risk of prostate cancer [see Indications and Usage (1.2), Warnings and Precautions (5.4), Adverse Reactions (6.1)].
17.4 Exposure of Women—Risk to Male Fetus
Physicians should inform patients that JALYN Capsules should not be handled by a woman who is pregnant or who could become pregnant because of the potential for absorption of dutasteride and the subsequent potential risk to a developing male fetus. Dutasteride is absorbed through the skin and could result in unintended fetal exposure. If a pregnant woman or woman of childbearing potential comes in contact with leaking JALYN Capsules, the contact area should be washed immediately with soap and water [see Warnings and Precautions (5.6), Use in Specific Populations (8.1)].
17.5 Instructions for Use
JALYN Capsules should be swallowed whole and not chewed, crushed, or opened. JALYN Capsules may become deformed and/or discolored if kept at high temperatures. If this occurs, capsules should not be used.
17.6 Priapism
Physicians should inform patients about the possibility of priapism as a result of treatment with JALYN or other alpha adrenergic antagonist-containing medications. Patients should be informed that this reaction is extremely rare, but can lead to permanent erectile dysfunction if not brought to immediate medical attention [see Warnings and Precautions (5.7)].
17.7 Blood Donation
Physicians should inform men treated with JALYN that they should not donate blood until at least 6months following their last dose to prevent pregnant women from receiving dutasteride through blood transfusion [see Warnings and Precautions (5.8)]. Serum levels of dutasteride are detectable for 4 to 6months after treatment ends [see Clinical Pharmacology (12.3)].
17.8 Intraoperative Floppy Iris Syndrome (IFIS)
Physicians should advise patients con |
