Dosing - AVODART® dutasteride

The capsules should be swallowed whole and not chewed or opened, as contact with the capsule contents may result in irritation of the oropharyngeal mucosa. AVODART® may be administered with or without food.

Monotherapy

The recommended dose of AVODART® is 1 capsule (0.5 mg) taken once daily.

Combination with Alpha-adrenergic Antagonist

The recommended dose of AVODART® is 1 capsule (0.5 mg) taken once daily and tamsulosin 0.4 mg taken once daily.

IMPORTANT SAFETY INFORMATION AND INDICATIONS

AVODART® is for adult men only. Women, children, and teenagers should not take AVODART®. Women should not touch AVODART® due to risk of a specific birth defect. If a woman comes in contact with leaking AVODART® capsules, she should wash the contact area immediately with soap and water.

Do not take AVODART® if you are allergic to dutasteride, finasteride, or any of the ingredients in AVODART®.

Before you take AVODART®, tell your doctor if you have liver disease.

Some types of medicines should be used with caution when taken with AVODART®, such as ritonavir.

You should not donate blood while taking AVODART® or for 6 months after you have stopped AVODART®. This is important to prevent pregnant women from receiving AVODART® through blood transfusions.

AVODART® may cause rare and serious allergic reactions, including swelling of your face, tongue, or throat, and serious skin reactions, such as skin peeling. Get medical help right away if you have these serious allergic reactions.

AVODART® may cause serious side effects including a higher chance of a more serious form of prostate cancer.

SIDE EFFECTS

The most commonly reported side effects in clinical trials were:

trouble getting or keeping an erection (impotence)
a decrease in sex drive (libido)
ejaculation problems
AVODART® has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of AVODART® on male fertility is not known

These are not all of the side effects reported. See full prescribing information.

Before Starting AVODART®:

Your healthcare provider may check you for other prostate problems, including prostate cancer, before you start and while you take AVODART®. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. AVODART® will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with AVODART® (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.

Only your healthcare provider can tell if your symptoms are due to BPH or a more serious condition like prostate cancer. See your doctor for regular exams.

While some men have fewer problems and symptoms after 3 months of treatment with AVODART®, a treatment period of at least 6 months is usually necessary to see if AVODART® will work for you.

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

These highlights do not include all the information needed to use AVODART® safely and effectively. See full prescribing information for AVODART®

Please read the accompanying Medication Guide for AVODART®, including the information about birth defects if taken during pregnancy, and discuss it with your doctor. The physician Prescribing Information also is available.

Monotherapy

Combination with Alpha-adrenergic Antagonist

Select Safety Information for AVODART®

IMPORTANT SAFETY INFORMATION AND INDICATIONS

SIDE EFFECTS

Before Starting AVODART®: