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    Leuprolide ACETATE Vial

    GENERIC NAME(S): Leuprolide

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    Uses

    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.

    Leuprolide is also used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

    How to use Leuprolide ACETATE Vial

    Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using leuprolide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

    This medication is given by injection under the skin as directed by your doctor, usually once a day.

    In children, the dosage is based on weight and response to treatment. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details.

    If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Learn how to store and discard medical supplies safely.

    Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

    Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

    During the first few weeks of treatment, your hormone levels will actually go up before they go down. This is a normal response to this medication. Your symptoms may get worse 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 right away if you have any bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, or inability to move.

    If you are using this medication to stop early puberty, you may notice worsening symptoms (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell the doctor promptly if new or worsened symptoms develop after starting treatment.

    Side Effects

    Mild burning/pain/bruising at the injection site, hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, vaginal bleeding, swelling of the ankles/feet, increased urination at night, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

    Infrequently in men, 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.

    In girls, when this medication is used regularly, it is expected that the menstrual period will stop or decrease to light bleeding/spotting during the first 2 months. Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide.

    Remember that the 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.

    Tell your doctor right away if any of these serious side effects occur: new/worsening bone pain (in adults), easily broken bones (in adults), increased thirst/urination (in adults), mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression).

    In adults, this medication may rarely cause heart problems and stroke. Get medical help right away if any of these very serioussymptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), fast/irregular heartbeat, severe dizziness, fainting.

    Get medical help right away if any of these very serious side effects occur: seizures.

    Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after the first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

    A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.

    In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

    Precautions

    Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or of any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), 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, high cholesterol, mental/mood problems (such as depression), seizures.

    In adults, 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 (for example, corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin).

    In adults, leuprolide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

    The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using leuprolide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

    Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using leuprolide safely.

    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.

    Before having surgery, tell your doctor or dentist about all the products being used (including prescription drugs, nonprescription drugs, and herbal products).

    Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

    This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

    It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

    Interactions

    Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

    This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

    Overdose

    If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

    Notes

    Do not share this medication with others.

    Lab and/or medical tests (such as hormone levels, PSA blood test for men, height measurements for children) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

    Missed Dose

    For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If a dose is missed, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

    Storage

    Different brands of this medication have differentstorage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Protect from light and freezing. Keep all medications 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.Information last revised May 2017. Copyright(c) 2017 First Databank, Inc.

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    leuprolide 1 mg/0.2 mL subcutaneous kit
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    leuprolide 1 mg/0.2 mL subcutaneous kit
    leuprolide 1 mg/0.2 mL subcutaneous kit

    Identification

    color
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    This medicine is a kit
    leuprolide 1 mg/0.2 mL subcutaneous solution
    leuprolide 1 mg/0.2 mL subcutaneous solution

    Identification

    color
    clear
    shape
    No data.
    imprint
    No data.
    This medicine is a clear, vial
    leuprolide 1 mg/0.2 mL subcutaneous kit
    leuprolide 1 mg/0.2 mL subcutaneous kit

    Identification

    color
    colorless
    shape
    No data.
    imprint
    No data.
    This medicine is a colorless, clear, kit
    leuprolide 1 mg/0.2 mL subcutaneous kit
    leuprolide 1 mg/0.2 mL subcutaneous kit

    Identification

    color
    colorless
    shape
    No data.
    imprint
    No data.
    This medicine is a colorless, clear, kit

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    Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

    CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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