leuprolide 45 mg (pediatric 6 month) intramuscular syringe kit

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Medication name

Generic name:
Leuprolide 6 month pediatric - intramuscular injection

Pronunciation
(LOO-proe-lide)

Brand name(s)
Lupron Depot-Ped

Uses

Leuprolide is used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for gender dysphoria.

How to use

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.

Side effects

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.

Precautions

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

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.

Overdose

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.

Notes

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.

Missed dose

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.

Storage

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.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised October 2023.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.