Leuprolide Injection (5 mg / mL)

For all patients taking leuprolide injection (5 mg/mL):

• If you have an allergy to leuprolide or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

Women:

• If you have unexplained vaginal bleeding.
• If you are pregnant or may be pregnant. Do not take leuprolide injection if you are pregnant.
• If you are breast-feeding. Do not breast-feed while you take this medicine.

Children:

• If your child is younger than 2 years of age. Do not give leuprolide injection to a child younger than 2 years of age.

This is not a list of all drugs or health problems that interact with this medicine.

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 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine 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 your doctor or pharmacist if you are not sure how to use leuprolide injection (5 mg/mL).
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Follow how to use as you have been told by the doctor or read the package insert.
• Wash your hands before and after use.
• Wear gloves while mixing and giving this medicine.
• 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.
• To gain the most benefit, do not miss doses.
• Keep using leuprolide injection as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

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:

For all patients taking leuprolide injection (5 mg/mL):

• 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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Seizures.
• Very bad irritation where the shot was given.
• A very bad pituitary gland problem (pituitary apoplexy) has rarely happened with leuprolide injection. 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.
• 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.

Adults:

• 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.
• Bone pain that is new or worse.
• Not able to pass urine or change in how much urine is passed.
• Very bad back pain.
• Blood in the urine.
• A burning, numbness, or tingling feeling that is not normal.
• Very bad dizziness or passing out.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Not able to move.
• Feeling very tired or weak.

Children:

• Vaginal itching or discharge.

If your child has menstrual periods:

• Period (menstrual) changes.

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.

• 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.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, 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.

This information should not be used to decide whether or not to take leuprolide injection or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to leuprolide injection. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017