Brand Name(s):

    
  • Eligard®
  • Lupron®
  • Lupron Depot®
  • Lupron Depot-PED®
  • Other Name(s):

        
  • Leuprorelin Acetate
  • WHY is this medicine prescribed?

    Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer. Leuprolide injection (Lupron Depot-PED) is used to treat central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) in girls usually younger than 8 years of age and in boys usually younger than 9 years of age. Leuprolide injection (Lupron Depot) is used alone or with other medication to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Leuprolide injection (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus). Leuprolide injection is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.

    HOW should this medicine be used?

    Leuprolide injection comes as a long-acting suspension (Lupron) that is injected intramuscularly (into a muscle) by a doctor or nurse in a medical office or clinic and is usually given once a month (Lupron Depot, Lupron Depot-PED) or every 3, 4, or 6 months (Lupron Depot-3 month, Lupron Depot-PED-3 month, Lupron Depot-4 month, Lupron Depot-6 Month). Leuprolide injection also comes as a long-acting suspension (Eligard) that is injected subcutaneously (just under the skin) by a doctor or nurse in a medical office or clinic and is usually given every 1, 3, 4, or 6 months. Your doctor will tell you how long your treatment with leuprolide injection will last. When used in children with precocious puberty, leuprolide injection (Lupron Depot-PED, Lupron Depot-PED-3 month) will likely be stopped by your child's doctor before 11 years of age in girls and 12 years of age in boys.

    If you receive leuprolide long-acting suspension (Eligard) as a subcutaneous injection, you may notice a small bump at the place where the injection was given when you first receive the medication. This bump should eventually go away.

    Leuprolide may cause an increase in certain hormones in the first few weeks after injection. Your doctor will monitor you carefully for any new or worsening symptoms during this time.

    Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before receiving leuprolide injection,

        
  • tell your doctor and pharmacist if you are allergic to leuprolide, goserelin (Zoladex), histrelin (Supprelin LA, Vantas), nafarelin (Synarel), triptorelin (Trelstar), any other medications, or any of the ingredients in leuprolide injection. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: certain medications for irregular heartbeat such as amiodarone (Cordarone), disopyramide (Norpace), procainamide (Procanbid), quinidine, and sotalol (Betapace, Betapace AF, Sorine); medications for seizures; or oral steroids such as dexamethasone (Decadron, Dexpak), methylprednisolone (Medrol), and prednisone (Sterapred). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have unusual vaginal bleeding. Your doctor may tell you not to use leuprolide injection.
  • tell your doctor if you or anyone in your family has or has ever had osteoporosis (condition where bones are thin and more likely to break); if you have a history of drinking alcohol or using tobacco products for a long period of time; or if you have or have ever had depression, cancer that has spread to the spine (backbone), diabetes, urinary obstruction (blockage that causes difficulty urinating), blood in your urine, a prolonged QT interval (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death), heart disease, or a low level of potassium, calcium, or magnesium in your blood.
  • you should know that leuprolide is not to be used in women who are pregnant, can become pregnant, or are breast-feeding. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. Your doctor may perform a pregnancy test to be sure that you are not pregnant when you begin receiving leuprolide injection. You will need to use a reliable nonhormonal method of birth control to prevent pregnancy while you are receiving leuprolide injection. Talk to your doctor about the types of birth control that are right for you, and continue to use birth control even though you should not have regular menstrual periods during your treatment. If you think you have become pregnant while receiving leuprolide injection, call your doctor immediately. Leuprolide injection can harm the fetus.
  • plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Leuprolide injection may make your skin sensitive to sunlight.
  • What SPECIAL DIETARY instructions should I follow?

    Unless your doctor tells you otherwise, continue your normal diet.

    What should I do IF I FORGET to take a dose?

    If you miss an appointment to receive an injection of leuprolide, you should call your healthcare provider right away to reschedule your appointment.

    What SIDE EFFECTS can this medicine cause?

    Leuprolide injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

        
  • tiredness
  • hot flashes (a sudden wave of mild or intense body heat), sweating, or clamminess
  • breast tenderness, pain, or change in breast size in both men and women
  • vaginal discharge, dryness, or itching in women
  • spotting (light vaginal bleeding) or menstruation (periods)
  • decrease in size of testicles
  • decrease in sexual ability or desire
  • swelling of the hands, feet, ankles, or lower legs
  • pain, burning, or tingling in the hands or feet
  • pain, burning, bruising, or hardening at place where injection was given
  • change in weight
  • muscle or joint pain
  • flu-like symptoms
  • acne
  • depression
  • unable to control emotions and frequent mood changes
  • nervousness
  • general feeling of discomfort or uneasiness
  • difficulty with memory
  • Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

        
  • redness or swelling at place where injection was given
  • itching, rash, or hives
  • difficulty breathing or swallowing
  • pain in the arms, back, chest, neck, or jaw
  • slow or difficult speech
  • dizziness or fainting
  • weakness, numbness, or inability to move an arm or leg
  • bone pain
  • painful, frequent, or difficult urination
  • blood in urine
  • extreme thirst
  • weakness
  • dry mouth
  • nausea
  • vomiting
  • breath that smells fruity
  • decreased consciousness
  • sudden headache
  • blurred vision
  • vision changes
  • difficulty moving eyes
  • drooping eyelids
  • confusion
  • Leuprolide injection may cause a decrease in the density of your bones which can increase the chance of broken bones. Talk to your doctor about the risks of using this medication and to find out what you can do to decrease these risks.

    In children receiving leuprolide injection (Lupron Depot-PED) for precocious puberty, new or worsening symptoms of sexual development may occur during the first few weeks of treatment. In girls receiving leuprolide injection (Lupron Depot-PED) for precocious puberty, the onset of menstruation or spotting (light vaginal bleeding) may occur during the first two months of treatment. If bleeding continues beyond the second month, call your doctor.

    Leuprolide injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at Web Site] or by phone [1-800-332-1088].

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests and take certain measurements to check your body's response to leuprolide injection. Your blood sugar and glycosylated hemoglobin (HbA1c) should be checked regularly.

    Ask your pharmacist any questions you have about leuprolide injection.

    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: September 15, 2011.