Uses of Histrelin Implant:

• It is used to delay puberty in children who are maturing too early.
• If your child has been given histrelin implant (CPP) for some other reason, talk with the doctor about the benefits and risks. Talk with the doctor if you have questions or concerns about giving histrelin implant (CPP) to your child.

What do I need to tell my doctor BEFORE I take Histrelin Implant?

For all patients taking histrelin implant (CPP):

• If your child is allergic to histrelin implant (CPP); any part of histrelin implant (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 histrelin implant (CPP) to a child younger than 2 years of age.

If your child is or may be pregnant:

• If your child is pregnant or may be pregnant. Do not give histrelin implant (CPP) to your child if she is pregnant.

If your child is breast-feeding a baby:

• Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.

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 histrelin implant (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 Histrelin Implant?

For all patients taking histrelin implant (CPP):

• Tell all of your child's health care providers that your child is taking histrelin implant (CPP). This includes your child's doctors, nurses, pharmacists, and dentists.
• Rarely, the implant may come out from where it was put in. Call the doctor if this happens.
• Follow up with the doctor as you have been told.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your child's health care providers and lab workers that your child takes histrelin implant (CPP).
• 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 or may be 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 histrelin implant (CPP), call the doctor right away.

How is this medicine (Histrelin Implant) best taken?

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

• This medicine is placed under the skin in the upper arm. This is minor surgery. Your doctor will do this.
• Keep the arm where histrelin implant (CPP) is placed dry for 24 hours after it is placed. Avoid bathing and swimming for 24 hours.
• Do not remove any surgical strips. These will fall off on their own in a few days.
• Have your child avoid heavy play or exercise using the arm for 7 days after placement.

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.
• 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 Histrelin Implant?

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 implant was placed.
• If your child is taking histrelin implant (CPP) to delay puberty, you may see short-term body odor or signs of puberty like vaginal bleeding, enlarged breasts, or more pubic hair during the first month of care. If these last or are very bad, call the doctor.

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 Histrelin Implant?

• If you need to store histrelin implant (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. If you have any questions about histrelin implant (CPP), please talk with your child's doctor, nurse, pharmacist, or other health care provider.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about histrelin implant (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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