Uses of Leuprolide Injection:

• It is used to treat prostate cancer.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Leuprolide Injection?

• If you are allergic to leuprolide injection (prostate); any part of leuprolide injection (prostate); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you are a woman. This medicine is not approved for use in women. This medicine may cause harm to an unborn baby if it is taken during pregnancy. If you are a woman using leuprolide injection (prostate), talk with your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take leuprolide injection (prostate) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Leuprolide Injection?

• Tell all of your health care providers that you take leuprolide injection (prostate). This includes your doctors, nurses, pharmacists, and dentists.
• This medicine may raise some hormone levels in your body during the first few weeks of taking it. Disease signs may get worse before getting better. Tell your doctor if you have any new signs or if your disease signs are worse for longer than a few weeks after starting leuprolide injection (prostate).
• This medicine lowers some hormone levels in your body. This may cause some effects like change in breast size, breast soreness or tenderness, testicle changes in men, change in sex ability in men, hot flashes, or sweating. Talk with your doctor.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• High blood sugar has happened with leuprolide injection (prostate). This includes diabetes that is new or worse.
• Check your blood sugar as you have been told by your doctor.
• If you smoke, talk with your doctor.
• A very bad pituitary gland problem (pituitary apoplexy) has rarely happened with leuprolide injection (prostate). Most of the time, this has happened within 2 weeks after the first dose. Call your doctor right away if you have a sudden headache, throwing up, passing out, mood changes, eye weakness, not able to move your eyes, or change in eyesight.
• This medicine may cause weak bones. This may happen more often if used for a long time. This may raise the chance of broken bones. Call your doctor right away if you have bone pain.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• A higher chance of stroke or severe and sometimes deadly heart problems have been noted with the use of drugs like leuprolide injection (prostate) in men. The chance is low, but get medical help right away if you have chest pain or pressure, weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on 1 side of the face, or change in eyesight.
• Some products are not approved for use in people who are 65 or older or in children. Talk with your doctor.
• The chance of very bad and sometimes deadly problems may be raised in people who have growths on or near the spine or spinal cord or bladder blockage. Talk with your doctor.
• Lowering male hormones in the body may raise the chance of a type of heartbeat that is not normal called prolonged QT interval. Talk with the doctor.
• This medicine may affect being able to father a child. Talk with the doctor.

How is this medicine (Leuprolide Injection) best taken?

Use leuprolide injection (prostate) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot.
• Some products need to be given into the fatty part of the skin. Some products need to be given into a muscle. Talk with the doctor or pharmacist if you are not sure how to use leuprolide injection (prostate).
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Wash your hands before and after use.
• Wear gloves while mixing and giving leuprolide injection (prostate).
• Move the site where you give the shot with each shot.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Keep using leuprolide injection (prostate) as you have been told by your doctor or other health care provider, even if you feel well.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take leuprolide injection (prostate).

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of dehydration like dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast breathing; or confusion.
• Bone pain that is new or worse.
• Not able to pass urine or change in how much urine is passed.
• Very bad back pain.
• Seizures.
• Blood in the urine.
• A burning, numbness, or tingling feeling that is not normal.
• Very bad dizziness or passing out.
• Fast, slow, or abnormal heartbeat.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Not able to move.
• Behavior and mood changes have happened with the use of drugs like this one in children. This includes acting aggressive, crying, depression, emotional ups and downs, restlessness, and feeling angry and irritable. Call your doctor right away if you have any new or worse behavior or mood changes.

What are some other side effects of Leuprolide Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Feeling dizzy, tired, or weak.
• Not hungry.
• Constipation.
• Upset stomach or throwing up.
• Trouble sleeping.
• Irritation where the shot is given.
• Muscle or joint pain.
• Flu-like signs.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Leuprolide Injection?

• Most of the time, leuprolide injection (prostate) will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about leuprolide injection (prostate), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

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