Lupron Depot Depot Suspension

Generic Name: Leuprolide 30 mg (4-month formulation) Intramuscular Depot Suspension (loo-PRO-lide)
Brand Name: Lupron Depot

Lupron Depot Depot Suspension is used for:

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

Lupron Depot Depot 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 Lupron Depot Depot Suspension if:

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

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

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

• Lupron Depot Depot Suspension comes with an additional patient leaflet. Read it carefully and reread it each time you get Lupron Depot Depot Suspension refilled.
• Lupron Depot Depot Suspension is usually administered every 4 months (16 weeks) as an injection at your doctor's office, hospital, or clinic. If you are using Lupron Depot 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.
• If you miss a dose of Lupron Depot Depot Suspension, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Lupron Depot 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, 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.
• Lupron Depot Depot 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 Lupron Depot Depot Suspension.
• Lupron Depot Depot Suspension is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Use of Lupron Depot 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 Depot Suspension is excreted in breast milk. Do not breast-feed while taking Lupron Depot Depot Suspension.

Possible side effects of Lupron Depot 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 sleeping; hot flashes/sweating; impotence; infection (fever, chills, sore throat); nausea or vomiting; pain, redness, or swelling at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

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.

Proper storage of Lupron Depot Depot Suspension:

Store Lupron Depot 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. 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 Lupron Depot Depot Suspension out of the reach of children and away from pets.

General information:

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