Fensolvi (6 Month), Lupron -ped (6-month)

Leuprolide Injection (CPP)

(loo PROE lide)

Lupron Depot-Ped

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

If your child is allergic to this drug; any part of this drug; 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 this drug to a child younger than 2 years of age. If your child is pregnant: Do not give this drug 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 this drug. This drug 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 this drug 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.

Tell all of your child's health care providers that your child is taking this drug. This includes your child's doctors, nurses, pharmacists, and dentists. Have blood work checked as you have been told by the doctor. Talk with the doctor. This drug may affect certain lab tests. Tell all of your child's health care providers and lab workers that your child takes this drug. This drug 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 drug 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 this drug to make sure she is not pregnant. If your child is pregnant: This drug may cause harm to the unborn baby if your child takes it during pregnancy. If your child is pregnant or gets pregnant while taking this drug, call the doctor 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. A very bad pituitary gland problem (pituitary apoplexy) has rarely happened with this drug. 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.

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. Signs of a common cold. Nose or throat irritation. Cough. Stomach pain. Constipation. 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.

Give this drug as ordered by your child's doctor. Read all information given to you. Follow all instructions closely. It is given as a shot.

Call your child's doctor to find out what to do.

If you need to store this drug at home, talk with your child's doctor, nurse, or pharmacist about how to store it.

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 this drug, 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 this medicine 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 this medicine. 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.