Lupron Depot Suspension

Lupron Depot Suspension is used for:

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Treating symptoms of advanced prostate cancer and certain conditions as determined by your doctor.

Lupron Depot Suspension is a gonadotropin-releasing hormone agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries and preventing the growth of certain tumors which need these hormones to grow.

Do NOT use Lupron Depot Suspension if:

• you are allergic to any ingredient in Lupron Depot 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 Lupron Depot Suspension:

Some medical conditions may interact with Lupron Depot 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 genital, urinary, or bone problems
• if you have vaginal bleeding

Some MEDICINES MAY INTERACT with Lupron Depot Suspension. However, no specific interactions with Lupron Depot 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 Lupron Depot 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 Lupron Depot Suspension:

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

• Lupron Depot Suspension comes with an additional patient leaflet. Read it carefully and reread it each time you get Lupron Depot Suspension refilled.
• Lupron Depot Suspension is usually administered every 3 months (84 days) as an injection at your doctor's office, hospital, or clinic. If you are using Lupron Depot 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.
• Do not miss any doses of Lupron Depot Suspension. Missing doses will decrease the effectiveness of Lupron Depot Suspension.

Ask your health care provider any questions you may have about how to use Lupron Depot 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 may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Lupron Depot Suspension is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
• Use of Lupron Depot 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 Lupron Depot Suspension is excreted in breast milk. Do not breast-feed while taking Lupron Depot Suspension.

Possible side effects of Lupron Depot 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 breathing; difficulty sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain; swelling; urination problems.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in urine; difficulty breathing; dizziness or lightheadedness; emphysema; increase in bone pain; severe drowsiness; severe headache; swelling of the lungs; unusual or one-sided 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 Lupron Depot Suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Because the product does not contain a preservative, once mixed, the suspension should be discarded if not used immediately. Keep Lupron Depot Suspension out of the reach of children and away from pets.

General information:

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