Uses of Leuprolide Injection:

• It is used to delay puberty in children who are maturing too early.

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

• If your child is allergic to leuprolide injection (CPP); any part of leuprolide injection (CPP); or any other drugs, foods, or substances. Tell the doctor about the allergy and what signs your child had.
• If your child is younger than 2 years of age. Do not give leuprolide injection (CPP) to a child younger than 2 years of age.

If your child is pregnant:

• Do not give leuprolide injection (CPP) to your child if she is pregnant.

If your child is breast-feeding a baby:

• Be sure your child does not breast-feed a baby while taking leuprolide injection (CPP).

This medicine may interact with other drugs or health problems.

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

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

• Tell all of your child's health care providers that your child is taking leuprolide injection (CPP). This includes your child's doctors, nurses, pharmacists, and dentists.
• Have your child's blood work checked often. Talk with your child's doctor.
• This medicine may affect certain lab tests. Tell all of your child's health care providers and lab workers that your child takes leuprolide injection (CPP).
• This medicine may raise some hormone levels in your child's body during the first few weeks of taking it. Puberty signs like vaginal bleeding or spotting may happen or get worse before getting better. Tell the doctor if your child has any new signs or if your child still has puberty signs after 2 months of care.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• If your child is of childbearing age, a pregnancy test will need to be done before starting leuprolide injection (CPP) to make sure she is not pregnant.

If your child is pregnant:

• This medicine may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking leuprolide injection (CPP), call the doctor right away.

How is this medicine (Leuprolide Injection) best taken?

Give leuprolide injection (CPP) as ordered by your child's doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into the muscle.

What do I do if I miss a dose?

• Call your child's 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 child's doctor or get medical help right away if your child has 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.
• Seizures.
• Swelling or numbness in the arms or legs.
• Vaginal bleeding that is not normal.
• Vaginal itching or discharge.
• Very bad bone pain.
• Chest pain.
• Very bad belly pain.
• A very bad pituitary gland problem (pituitary apoplexy) has rarely happened with leuprolide injection (CPP). Most of the time, this has happened within 2 weeks after the first dose. Call the doctor right away if your child has a sudden headache, throwing up, passing out, mood changes, eye weakness, not able to move 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 child's doctor right away if your child has 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 child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

• Irritation where the shot is given.
• Headache.
• Hot flashes.
• Sweating a lot.
• Pimples (acne).
• Weight gain.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's 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?

• If you need to store leuprolide injection (CPP) at home, talk with your child's doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your child's symptoms or health problems do not get better or if they become worse, call your child's doctor.
• Do not share your child's drug with others and do not give anyone else's drug to your child.
• 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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about leuprolide injection (CPP), 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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