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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.

Specific Dosing for Your Child’s Needs

3-month and 1-month dosing options available1

LUPRON DEPOT-PED is available in 3-month dosing options (once every 3 months) and 1-month dosing options (once per month). With 3-month dosing, your child will get 4 injections per year instead of the 12 required with monthly dosing. If your child receives a LUPRON DEPOT-PED injection every 3 months, injections may be scheduled to coincide with his or her regular doctor visits and allow for more flexibility to fit your schedule.

Dosing Options
  • Two depot formulation options (LUPRON DEPOT-PED 11.25 mg and 30 mg for 3-month administration) are available and are given as an injection every 3 months (12 weeks).
  • Three depot formulation options (LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg for 1-month administration) are available and are given as an injection every 4 weeks.
  • Your pediatric endocrinologist may monitor your child’s response to treatment 2–3 months (for 3-month dosing) or 1–2 months (for monthly dosing) after starting therapy and may want to measure bone age every 6–12 months.
  • Upon discontinuation of treatment, suppression of the hormones stops.

Individualized dosing with LUPRON DEPOT-PED1

Every child has unique needs—including the amount of medicine needed to suppress the onset of puberty. The multiple dosing options offered by LUPRON DEPOT-PED can help your child’s physician customize treatment for your child. With a number of dosing options to choose from, your doctor can make sure your child gets the right dosage. And with ongoing monitoring, your doctor has the flexibility to choose a different dose if needed.

Your child’s pediatric endocrinologist will individualize the LUPRON DEPOT-PED dose for your child. If hormone and clinical suppression are not achieved with the starting dose, the doctor may need to adjust the dosage level. The dose may also need to be adjusted as your child’s body weight changes.

Safety Considerations: Before starting treatment talk to your child's pediatric endocrinologist about your child's medical history and all other medicines that your child takes. 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.

Reference: 1. LUPRON DEPOT-PED [package insert].

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.