Leuprolide Injection

Leuprolide injection is used to treat

• certain types of prostate cancer
• 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)
• endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy, irregular bleeding)
• anemia (a lower-than-normal number of red blood cells) caused by uterine fibroids (growths in the uterus that are not cancer).

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.

Leuprolide injection comes as a long-acting suspension (liquid) that is injected intramuscularly (into a muscle) or subcutaneously (just under the skin) by a doctor or nurse in a medical office or clinic. It is given once a month or once every 3, 4, or 6 months.  Your doctor will tell you how often you will receive long-acting leuprolide injection. Leuprolide injection also comes as a solution (that is injected subcutaneously once a day. Your doctor will select the best product for your condition and tell you how long your treatment will last. 

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.

If you are injecting leuprolide injection solution, you may receive your first in your doctor's office. After that, your doctor may allow you or a caregiver to give the injections at home. Before you use leuprolide injection solution yourself the first time, read the manufacturer's information for the patient that comes with the medication. Ask your doctor or pharmacist to show you or your caregiver how to inject it.

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

Leuprolide injection may also be used to treat certain types of breast cancer. 

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

Before receiving leuprolide injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• 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) or long QT syndrome (a rare heart problem that may cause irregular heartbeat, fainting, or sudden death); or if you have a history of drinking alcohol or using tobacco products for a long period of time. Also tell your doctor if you have or have ever had mental problems such as depression, seizures, brain tumors, cancer that has spread to the spine (backbone), diabetes, a blockage that causes difficulty urinating, cerebrovascular disease (clogging or weakening of the blood vessels in the brain or leading to the brain), heart disease, stroke, high cholesterol, 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 breastfeeding. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You may have to take a pregnancy test before starting treatment. You may need to use effectivee nonhormonal birth control to prevent pregnancy during your treatment. Talk to your doctor about the types of birth control that are right for you. Continue to use birth control even though you should not have regular menstrual periods during your treatment. If you become pregnant while receiving leuprolide injection, call your doctor immediately. Leuprolide injection may harm the fetus.
• you should know that leuprolide injection may impair fertility in men

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

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

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, bleeding, dryness, or itching
• 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, redness, or hardening at place where injection was given
• change in weight
• muscle or joint pain
• runny nose, cough, sore throat, or flu-like symptoms
• stomach pain
• constipation
• headache
• acne
• weakness
• dizziness
• nausea
• increase in frequency of urination or having to urinate at night
• night sweats
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• itching; rash; hives; difficulty breathing or swallowing; hoarseness; fast heartbeat; dizziness; fainting; swelling of the face, eyes, mouth, throat, tongue, or lips
• dry, itchy, blistering, or peeling skin; rash; acne; redness or swelling of your face, hands or soles of your feet; mouth sores or blisters; muscle or joint pain; swollen glands; fever; or flu-like symptoms
• chest pain; shortness of breath; rapid or irregular heartbeat; or pain in the arms, back, neck, or jaw
• slow or difficult speech; dizziness or fainting; weakness, numbness, or inability to move an arm or leg; sudden severe headache
• bone pain
• painful, frequent, or difficult urination or blood in the urine
• extreme thirst, weakness, dry mouth, nausea, vomiting, breath that smells fruity, decreased consciousness
• headache; blurred vision, double vision, or loss of vision; ringing in the ears; dizziness; or nausea
• crying, irritability, impatience, anger, or aggressive behavior
• new or worsening depression
• seizures

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 for precocious puberty, new or worsening symptoms of sexual development may occur during the first few weeks of treatment. In girls receiving leuprolide injection 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

If you are using leuprolide injection solution, your healthcare provider will tell you how to store your medication. Store your medication only as directed. Make sure you understand how to store your medication properly

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to leuprolide injection.  

Ask your pharmacist any questions you have about leuprolide injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

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