HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use JALYN safely and effectively. See full prescribing information for JALYN.
JALYN (dutasteride and tamsulosin hydrochloride) Capsules
Initial U.S. Approval: 2010
RECENT MAJOR CHANGES
Indications and Usage, Limitations of Use (1.2) June 2011
Warnings and Precautions, Increased Risk of High-grade
Prostate Cancer (5.4) June 2011
INDICATIONS AND USAGE
JALYN is a combination of dutasteride, a 5 alpha-reductase inhibitor, and tamsulosin, an alpha adrenergic antagonist, indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate. (1.1)
Limitations of Use: Dutasteride-containing products, including JALYN, are not approved for the prevention of prostate cancer. (1.2)
DOSAGE AND ADMINISTRATION
Take one capsule daily approximately 30minutes after the same meal each day. (2)
Swallow capsule whole. (2)
DOSAGE FORMS AND STRENGTHS
0.5mg dutasteride and 0.4mg tamsulosin hydrochloride. (3)
CONTRAINDICATIONS
Pregnancy and women of childbearing potential. (4, 5.6, 8.1)
Pediatric patients. (4)
Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema) to dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any component of JALYN. (4)
WARNINGS AND PRECAUTIONS
Orthostatic hypotension and/or syncope can occur. Advise patients of symptoms related to postural hypotension and to avoid situations where injury could result if syncope occurs. (5.1)
Do not use JALYN with other alpha adrenergic antagonists, as this may increase the risk of hypotension. (5.2)
JALYN reduces serum prostate-specific antigen (PSA) concentration by approximately 50%. However, any confirmed increase in PSA while on JALYN may signal the presence of prostate cancer and should be eva luated, even if those values are still within the normal range for untreated men. (5.3)
Do not use JALYN with strong inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole). Use caution in combination with moderate CYP3A4 inhibitors (e.g., erythromycin) or strong (e.g., paroxetine) or moderate CYP2D6 inhibitors, or known poor metabolizers of CYP2D6. Concomitant use with known inhibitors can cause a marked increase in drug exposure. (5.2, 7.1, 12.3)
Exercise caution with concomitant use of PDE-5 inhibitors, as this may increase the risk of hypotension. (5.2)
Drugs that contain dutasteride, including JALYN, may increase the risk of high-grade prostate cancer. (5.4, 6.1)
Assess patients to rule out other urological diseases, including prostate cancer, prior to prescribing JALYN. (5.5)
Women who are pregnant or could become pregnant should not handle JALYN Capsules due to potential risk to a male fetus. (5.6, 8.1)
Advise patients about the possibility and seriousness of priapism. (5.7)
Patients should not donate blood until 6months after their last dose of JALYN. (5.8)
Intraoperative Floppy Iris Syndrome has been observed during cataract surgery after alpha adrenergic antagonist exposure. Advise patients considering cataract surgery to tell their ophthalmologist that they take or have taken JALYN Capsules. (5.9)
Exercise caution with concomitant use of warfarin. (5.2, 7.4. 12.3)
ADVERSE REACTIONS
The most common adverse reactions, reported in ≥1% of patients, tre