• 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]. North Chicago, IL: Abbott Laboratories.

    202-653313
  • 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]. North Chicago, IL: Abbott Laboratories.

    202-653313
  • 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]. North Chicago, IL: Abbott Laboratories.

    202-653313
  • 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]. North Chicago, IL: Abbott Laboratories.

    202-653313
  • 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 (1-888-4PPANOW) for assistance.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert]. North Chicago, IL: Abbott Laboratories.

    202-653313
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 CPP that would require different treatment (e.g., tumors).

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

When Could Signs of Early Puberty in Girls Be Central Precocious Puberty (CPP)?

Watch for these signs of CPP in girls

How can you tell whether your child is just developing early, or whether she has central precocious puberty (CPP)? The signs of "normal" pubertyPuberty: the period when a person begins to develop secondary sex characteristics and becomes capable of sexual reproduction are similar to the signs of CPP—it's the timing that's different.1 Becoming familiar with the normal changes in girls can help you better understand your own child's development.

Here are some common signs of puberty in girls. If your child is showing any of these signs earlier than she should (typically age 8 or younger),2 be sure to talk with your child's physician as it could be CPP.

  • Sudden growth spurt3

    One of the most noticeable changes is a sudden gain in height. Often, girls will have their first pubertal growth spurt earlier than boys. This usually occurs between 9½–14½ years of age. Use this growth chart to see how your child compares with other kids in her age range.

  • Development of breast "buds"3

    Breast development normally occurs in girls from age 8–13. This is when nipples and breasts rise slightly as milk and fat tissue form. The areolas may also start getting bigger and darker.

    Your physician may refer to a specific "Tanner stageTanner stage: a stage of puberty as set out on the Tanner growth chart, based on the growth of pubic hair in both sexes, the development of the genitalia in boys, and the development of the breasts in girls2" when discussing your child's breast development. Physicians use Tanner stages to chart a child's progression through the different stages of puberty based on what type of physical characteristics they're showing.2

  • Menstrual periods3,4

    Girls usually get their first period anywhere from age 10–16½. You may see an increased amount of clear vaginal discharge before you see any blood. The amount of blood can vary widely from girl to girl.

  • Pubic and underarm hair3,4

    Normally, girls start growing pubic hair between the ages of 8–14. At first this hair will be fine and straight. Eventually pubic hair will grow thicker and become curly. As with breast development, your physician might refer to a specific Tanner stage when discussing the development of pubic hair in your child.2

    Underarm hair normally appears about 2 years after the first appearance of pubic hair.

Pubic hair growth

Genital development

Stage 1

(Prepubertal)

 Stage 1

Stage 2

 Stage 2

Stage 3

 Stage 3

Stage 4

 Stage 4

Stage 5

(Mature Adult)

 Stage 5

Line Drawing of Tanner Stages for Girls: Pubic Hair and Breast Development. Adapted from: Brown RT. Adolescent growth and development. In: Holland-Hall C, Brown RT, eds. Adolescent Medicine Secrets. Philadelphia, PA: Hanley & Belfus, Inc.; 2002:21-28

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References: 1. Kaplowitz PB. Precocious puberty [eMedicine from WebMd Web site]. Available at: http://www.emedicine.medscape.com/article/924002-print. Accessed March 29, 2011. 2. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381. 3. Hayward C. Gender Differences in Puberty. Cambridge, England: University Press; 2003. 4. Blondell RD, et al. Disorders of Puberty. Am Fam Physician. 1999;60:209-224.
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If you cannot afford your medication, contact www.pparx.org or call the toll-free number 1-888-477-2669.

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