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