Leuprolide Injection

WHY is this medicine prescribed?

Leuprolide injection is used to treat

• symptoms associated with advanced prostate cancer (Eligard, Lupron Depot, Camcevi).
• central precocious puberty (CPP; a condition causing girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) in children 2 years of age or older (Fensolvi, Lupron Depot-PED)
• 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) (Lupron Depot).
• anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus) (Lupron Depot).

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.

Are there OTHER USES for this medicine?

Leuprolide injection may also be used to stop ovulation in certain women with hormone-positive breast cancer that have not yet undergone menopause (stops having menstrual periods). This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Leuprolide injection comes as a long-acting suspension 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 or every 1, 3, 4, or 6 months depending on the product chosen for you (Lupron Depot-PED, Lupron Depot, leuprolide acetate for suspension). Leuprolide injection also comes as a long-acting suspension 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 depending on the product chosen for you (Camcevi, Eligard, Fensolvi). 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, Fensolvi) will likely be stopped by your child's doctor before 11 years of age in girls and 12 years of age in boys.

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.

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 (Triptodur, 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 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); 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, seizures, brain tumors, 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), cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain), heart disease, stroke, hyperlipidemia (elevated 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. 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.

• you should know that leuprolide injection may impair infertility (ability to make babies) in men

• you should know that some patients who receive leuprolide injection may have increasing difficulty controlling emotions, worsening mood or anxiety, or development of any new psychiatric illness. Report any new or worsening symptoms to your doctor, nurse, or pharmacist.

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, 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
• fever
• 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, 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
• 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 may worsen or cause certain metabolic disorders such as diabetes or hyperglycemia (elevated blood glucose), hyperlipidemia, or cirrhosis or non-alcoholic liver disease. Your doctor will monitor your cholesterol, glucose and liver functions carefully during treatment. Talk to your doctor about any concerns you may have before or during treatment.

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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

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.

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) may also 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.