Eligard Suspension

Eligard Suspension is used for:

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

Eligard Suspension 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 Suspension if:

• you are allergic to any ingredient in Eligard Suspension
• 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 Suspension:

Some medical conditions may interact with Eligard Suspension. 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 Suspension. However, no specific interactions with Eligard Suspension 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 Suspension 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 Suspension:

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

• Eligard Suspension comes with an additional patient leaflet. Read it carefully and reread it each time you get Eligard Suspension refilled.
• Eligard Suspension is usually administered every 4 months (16 weeks) as an injection at your doctor's office, hospital, or clinic. If you are using Eligard Suspension 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. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper disposal.
• If you miss a dose of Eligard Suspension, contact your doctor immediately.

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

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 Suspension 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 Suspension.
• Eligard Suspension is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Use of Eligard Suspension 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 Suspension is excreted in breast milk. Do not breast-feed while taking Eligard Suspension.

Possible side effects of Eligard Suspension:

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; 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 about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects 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), or emergency room immediately.

Store Eligard Suspension in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Once mixed, Eligard Suspension must be used within 30 minutes. Discard Eligard Suspension if it is not used within 30 minutes. Keep Eligard Suspension out of the reach of children and away from pets.

General information:

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

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