Lupron Depot-Ped

Read the Medication Guide provided by the pharmacist before your child starts using leuprolide and each time you get a refill. If you have any questions, ask the doctor or pharmacist.

This medication is given by injection into a muscle by a health care professional. It is given as directed by the doctor, usually once every 6 months (every 24 weeks). This product slowly releases the medication into the blood over a 6-month period.

In children, the dosage is based on weight and response to treatment. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details.

If you are using this medication at home, learn all preparation and usage instructions from the health care professional and the product package. Learn how to store and discard medical supplies safely.

Wash your hands and properly mix the medication. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Inject each dose within 2 hours of mixing. If more than 2 hours have passed since mixing, throw out the product and prepare another syringe/dose.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when your child should receive the next dose.

During the first few weeks of treatment, hormone levels will actually go up before they go down. This is a normal response to this medication. You may notice worsening symptoms of early puberty (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell the doctor promptly if new or worsened symptoms develop after starting treatment.

Headache, fever, stomach pain, diarrhea, increased sweating, weight gain, trouble sleeping, breast tenderness, or mild pain/bruising/swelling at the injection site may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

When this medication is used regularly, it is expected that the menstrual period will stop or decrease to light bleeding/spotting during the first 2 months. Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide.

Remember that this medication has been prescribed because the doctor has judged that the benefit is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if your child has any serious side effects, including: mental/mood changes (such as non-stop crying, irritability, mood swings, aggression).

Get medical help right away if your child has any very serious side effects, including: seizures.

Children using leuprolide may be at risk for increased pressure around the brain (intracranial hypertension). Get medical help right away if your child has any of these very serious side effects: nausea/vomiting that doesn't stop, headache that is severe or doesn't go away, eye pain, vision changes (such as blurred/double vision, decreased vision), ringing in the ears.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using leuprolide, tell the doctor or pharmacist if your child is allergic to it; or to similar drugs (such as histrelin, triptorelin); or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist your child's medical history, especially of: mental/mood problems (such as depression), seizures.

Before having surgery, tell the doctor or dentist about all the products being used (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products used (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all the doctors know your child uses this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Do not share this medication with others.

Lab and/or medical tests (such as hormone levels, height measurements, bone tests) should be done while using this medication. Keep all medical and lab appointments. Consult the doctor for more details.

It is important to get each dose of this medication as scheduled. If a dose is missed, ask the doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Store at room temperature away from light and moisture. After mixing, use the medication right away. Throw away the mixed medication if not used within 2 hours. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.