Important Information for patients using Viadur for the treatment of symptoms of advanced prostate cancer.

Please read this information before you start using Viadur. Each time another Viadur is inserted, check the patient information leaflet for any new information. Remember, this information does not take the place of your doctor's instructions. Ask your doctor or pharmacist if you have questions or want more information about Viadur.

Viadur is a drug-delivery system that contains the drug leuprolide and is placed under the skin. It looks like a small, thin metal tube. After it is placed under the skin, Viadur delivers leuprolide to your body continuously for 12 months.

Leuprolide, the active medication in Viadur, works by reducing the testosterone produced by the testicles. This lowers the amount of testosterone in the body. Testosterone appears to be needed by prostate cancer cells. Usually prostate cancer shrinks or stops growing when the body's supply of testosterone is lowered.

By lowering the amount of testosterone in the body, Viadur may help relieve the pain, urinary problems, and other symptoms of prostate cancer. However, Viadur is not a cure for prostate cancer. Once Viadur is removed by your doctor, your body will start producing testosterone again.

How is Viadur given?

Viadur will be placed under the skin of your upper, inner arm. The doctor will numb your arm, make a small incision, and then place Viadur under the skin. The incision will be closed with special surgical tape and covered with a bandage. You should keep the bandage in place for a few days until the incision heals.

After 12 months, Viadur must be removed and may be replaced with a new Viadur by your doctor.

After Viadur is inserted, keep the site clean and dry for 24 hours. Do not bathe or swim for 24 hours. Avoid heavy lifting and physical activity for 48 hours. Avoid bumping the site for a few days. After the cut has healed, you should be able to go back to your normal activities.

• If you notice unusual bleeding, redness or pain at the insertion site, contact your doctor.
• In the first few weeks of treatment, if you experience increased pain throughout your body, weakness, or numbness, contact your doctor.
• X-rays and MRI do not affect Viadur.
• Viadur is seen on X-rays. Slight image distortion around Viadur may occur during MRI procedures.
• Viadur must be removed and may be replaced after 12 months.

Do not use Viadur if you are allergic to the drug leuprolide.

Do not use Viadur if you are a woman. Viadur is not approved for use by women of any age. Furthermore, use of Viadurin a woman who is or may become pregnant may cause harm to the baby. You may lose your baby through a miscarriage if the drug is used while you are pregnant.

Viadur was not studied in children and should not be used in children.

The most common side effects related to Viadur were hot flashes, lack of energy, depression, sweating, headache, bruising, and breast enlargement.

Prostate cancer-related symptoms may become worse during the first few weeks of treatment.

Like other similar treatment options, Viadur may cause impotence.

There may be some pain and discomfort during and after Viadur insertion and removal. Bruising may occur. Reactions, such as itching and redness, are usually mild and heal without treatment within two weeks. If they do not heal, contact your doctor.

There is a chance that your bones may become thinner if you use this type of drug for long periods of time. Ask your doctor if this is a risk for you.

This list is not a complete list of all the possible side effects. If you need more information, or are worried about these or other side effects, talk to your doctor or pharmacist.

Your doctor may measure blood levels of testosterone and prostate-specific antigen (PSA) during your treatment with Viadur.

Tell your doctor or pharmacist about any medicines that you are taking, including Viadur, prescription, non-prescription, and herbal remedies. Do not start taking a new medicine before checking with your doctor or pharmacist.

For more information on Viadur, talk to your doctor or pharmacist.