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Eligard Injection Kit is used for:

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

Eligard Injection Kit 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 Eligard Injection Kit if:

• you are allergic to any ingredient in Eligard Injection Kit
• 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 Eligard Injection Kit:

Some medical conditions may interact with Eligard Injection Kit. 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 Eligard Injection Kit. However, no specific interactions with Eligard Injection Kit are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eligard Injection Kit 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 Eligard Injection Kit:

Use Eligard Injection Kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Eligard Injection Kit comes with an additional patient leaflet. Read it carefully and reread it each time you get Eligard Injection Kit refilled.
• Eligard Injection Kit is usually administered every month (4 weeks) as an injection at your doctor's office, hospital, or clinic. If you are using Eligard Injection Kit at home, carefully follow the injection procedures taught to you by your health care provider.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of this medicine, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Eligard Injection Kit.

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.
• Eligard Injection Kit 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 Eligard Injection Kit.
• Eligard Injection Kit is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Use of this medicine during pregnancy has resulted in fetal and newborn death. If you think you may be pregnant, contact your doctor immediately. It is unknown if Eligard Injection Kit is excreted in breast milk. Do not breast-feed while taking Eligard Injection Kit.

Possible side effects of Eligard Injection Kit:

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; constipation; decreased sex drive; difficulty sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain, redness, or swelling at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; chest pain; dizziness or lightheadedness; fast or irregular heartbeat; 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 Eligard Injection Kit in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Once mixed, Eligard Injection Kit must be used within 30 minutes. Discard Eligard Injection Kit if it is not used within 30 minutes. Keep Eligard Injection Kit out of the reach of children and away from pets.

General information:

• If you have any questions about Eligard Injection Kit, please talk with your doctor, pharmacist, or other health care provider.
• Eligard Injection Kit 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 Eligard Injection Kit. 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.