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|Viadur Implant

Viadur Implant

Viadur Implant is used for:

Treating symptoms of advanced prostate cancer. It may also be used for other conditions as determined by your doctor.

Viadur Implant is a gonadotropin-releasing hormone agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. It prevents the growth of certain tumors that need these hormones to grow.

Do NOT use Viadur Implant if:

• you are allergic to any ingredient in Viadur Implant
• you are pregnant, may become pregnant, or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Viadur Implant:

Some medical conditions may interact with Viadur Implant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you plan to become pregnant
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines or other substances
• if you have bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord
• if you have vaginal bleeding

Some MEDICINES MAY INTERACT with Viadur Implant. However, no specific interactions with Viadur Implant are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Viadur Implant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Viadur Implant:

Use Viadur Implant as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Viadur Implant comes with an additional patient leaflet. Read it carefully and reread it each time you get Viadur Implant refilled.
• Viadur Implant is an implant device that will be inserted at your doctor"s office, hospital, or clinic.
• If you miss a dose of Viadur Implant, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Viadur Implant.

Important safety information:

• Worsening of symptoms may occur during the first few weeks of treatment. Notify your doctor if any new or worsened symptoms occur.
• LAB TESTS, including blood testosterone levels, prostate-specific antigen (PSA), and bone density tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Viadur Implant may interfere with certain lab tests, including certain pituitary gland function tests. Be sure all of your doctors and lab personnel know you are using Viadur Implant.
• Viadur Implant is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Use of Viadur Implant during pregnancy has resulted in fetal and newborn death. If you think you may be pregnant, contact your doctor immediately. It is unknown if Viadur Implant is excreted in breast milk. Do not breast-feed while taking Viadur Implant.

Possible side effects of Viadur Implant:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Breast tenderness; burning, redness, itching, pain, or swelling around the implant; constipation; decreased sex drive; difficulty sleeping; headache; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; dizziness or lightheadedness; increase in bone pain; muscle weakness; paralysis; severe drowsiness; severe headache; shortness of breath; trouble urinating or inability to urinate; unusual or one-sided numbness or weakness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Viadur Implant at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Because the product does not contain a preservative, once mixed, the suspension should be discarded if not used immediately. Keep Viadur Implant out of the reach of children and away from pets.

General information:

• If you have any questions about Viadur Implant, please talk with your doctor, pharmacist, or other health care provider.
• Viadur Implant is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Viadur Implant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.