Lupron Depot

Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination.Talk to your doctor about the risks and benefits of treatment.

It is very important that you do not miss any doses. However, if you do miss a dose, contact your doctor promptly to establish a new schedule.

This medication is given as an injection into a muscle (intramuscularly), usually once every 4 months by a health care professional or as directed by your doctor. This product slowly releases the medication into your blood over a 4-month period. If you are directed to inject this medication yourself, learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If any of the information is unclear, consult your doctor or pharmacist. Change the location of the injection site each time to avoid problem areas under the skin. Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., blood testosterone level, PSA blood test, blood glucose) should be performed periodically to monitor your progress. Consult your doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart disease (such as heart attack), stroke, family history of sudden cardiac death. Leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use of certain medications (e.g., corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Leuprolide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. Non-hormonal birth control methods are recommended during treatment with leuprolide. It is not known if leuprolide passes into breast milk. Because the effects of leuprolide on a nursing infant are unknown, breast-feeding is not recommended. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Once mixed, use the medication immediately. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Hot flashes (flushing), increased sweating, night sweats, tiredness, swelling of the ankles/feet, increased urination at night, mental/mood changes (e.g., depression, mood swings), dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Infrequently, shrinking of the testicles, breast tenderness/swelling, and reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. During the first few weeks of treatment, your level of testosterone will actually increase before it decreases. This is a normal response by your body to this drug. This may sometimes result in new or worsening symptoms for a few weeks. If you have prostate cancer that has spread to the spine or caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor immediately if you experience any of the following serious side effects: bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, inability to move. Tell your doctor immediately if any of these unlikely but serious side effects occur: new/worsening bone pain, easily broken bones. Get medical help right away if any of these rare but serious side effects occur: chest discomfort/pain, irregular heartbeat, weakness on one side of the body, slurred speech. Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Other leuprolide products may also be used to treat disorders of the uterus (e.g., endometriosis, fibroids). In females, leuprolide reduces the amount of estrogen that the body makes. Leuprolide may also be used to stop early puberty in children.