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2016705-1878614

  • Do Not Take If
    • Your child should not receive any formulation of LUPRON DEPOT-PED if he/she has experienced any type of allergic reaction to LUPRON
      DEPOT-PED or similar drugs.

    • Females who are or may become pregnant should not receive any formulation of LUPRON DEPOT-PED.

    • LUPRON DEPOT-PED is not for children under 2 years of age.

    • View the full Prescribing Information for LUPRON DEPOT-PED.

    • Reference: LUPRON DEPOT-PED [package insert].

  • Before Starting
    • Talk to your child's doctor about your child's medical history and all other medicines that your child takes.

    • Convulsions have been observed in patients taking leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain disorders (related to blood vessels, nerves, or tumors), and in patients who are taking medications that have been associated with convulsions. Convulsions have also been reported in patients without any of these conditions.

    • View the full Prescribing Information for LUPRON DEPOT-PED.

    • Reference: LUPRON DEPOT-PED [package insert].

  • What to Expect
    • During the first weeks of treatment, signs of puberty, such as vaginal bleeding, may occur. This is a common initial effect of the drug. Notify your child's doctor if signs/symptoms of puberty continue beyond the second month of treatment.

    • After the injection, some pain and irritation is expected; however, if more severe symptoms occur or if any new, unusual, or worsened symptoms develop, contact your child's doctor.

    • Your child's initial response to LUPRON DEPOT-PED should be monitored, as well as their continued response during treatment, as clinically needed.

      • If your child receives a 1-month injection, response is assessed 1-2 months after the initial injection.
      • If your child receives a 3-month injection, response is assessed 2-3 months after the initial injection and at month 6.
      • Height and bone age should be checked every 6-12 months in children using either formulation of LUPRON DEPOT-PED.
    • It is important that you keep your child's doctor appointments and follow the prescribed injection schedule. Your child's pubertal development could begin again if injections are missed.

    • View the full Prescribing Information for LUPRON DEPOT-PED.

    • Reference: LUPRON DEPOT-PED [package insert].

  • Side Effects
    • The most common side effects with LUPRON DEPOT-PED and similar drugs are pain; acne; injection site reactions, including pain, swelling, and abscess; rash, including a painful rash with fever, blisters/sores, and facial swelling; vaginitis/vaginal bleeding/vaginal discharge; increased weight; altered mood; general pain; headache; fluctuating emotions; and hot flushes/sweating.

    • View the full Prescribing Information for LUPRON DEPOT-PED.

    • Reference: LUPRON DEPOT-PED [package insert].

  • Helpful Resources
    • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    • If you cannot afford your medication, contact www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

    • View the full Prescribing Information for LUPRON DEPOT-PED.

    • Reference: LUPRON DEPOT-PED [package insert].

Print Safety Facts

LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg for 1-month and 11.25 mg and 30 mg for 3-month administration are prescribed for the treatment of children with central precocious puberty (CPP).

Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Your doctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors).

LUPRON DEPOT-PED must be administered under the supervision of a physician.

Talking with Your Child’s Physician

How to start the conversation about central precocious puberty (CPP)

Whether you suspect your child might be showing symptoms of CPP, or your child has already been diagnosed and you are considering treatment with LUPRON DEPOT-PED, you are sure to have questions for your child’s physician. Here are some questions you can print out and bring with you to start the conversation.

After you’ve had a chance to research the signs and symptoms of CPP and the available treatment options, be sure to add your other questions to this list. Remember, only a doctor can determine whether your child has CPP.

Download and Save a PDF
of these questions to share
with your child’s pediatrician

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Questions about CPP

  • What is CPP, and what are the signs and symptoms?
  • Do you see signs of CPP in my child?
  • What are the long-term problems associated with CPP?
  • How will you diagnose CPP?

Diagnosing CPP

  • What tests will you use to diagnose my child?
  • Does my child need all these tests?

Treating CPP

  • What are the treatment options available?
  • What are the risks and benefits of each type of treatment?
  • How long will my child need treatment?
  • Will you need to monitor my child during treatment? How often?
  • How long will it take for my child to return to normal development?
  • What happens if we don’t treat this condition?

Choosing LUPRON DEPOT-PED to treat CPP

  • Why are you recommending (or not recommending) treatment with
    LUPRON DEPOT-PED?
  • How does treatment with LUPRON DEPOT-PED work?
  • Will the injections hurt?
  • Will there be any side effects?
  • What happens if we miss an injection?

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact www.pparx.org or call the toll-free number 1-888-477-2669.