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  • 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.

What is Central Precocious Puberty (CPP)?

When is early puberty actually CPP?1-4

PubertyPuberty: the period when a person begins to develop secondary sex characteristics and becomes capable of sexual reproduction normally begins in girls between the ages of 8 and 13 and in boys between the ages of 9 and 14. The signs of "normal" puberty are similar to the signs of CPP — it's the timing that's different.

Central precocious puberty (sometimes called "CPP" or "precocious puberty") is a condition where puberty starts too soon in children—usually in girls under 8 years old and in boys under 9 years old. Overall, CPP only occurs in 1 out of every 5,000 to 10,000 children and is more common in girls.

Though there are a few types of precocious puberty, CPP is the most common. It occurs when the brain releases certain hormonesHormone: a chemical substance produced in an organ of the body (like the adrenal glands or the pituitary gland) and carried to another organ or tissue in the body, where it has a specific effect too early. These hormones are the ones that are responsible for puberty. The condition is called "central" precocious puberty because the brain is part of the central nervous system.

Your child's physician will ask you some questions, perform a physical examination, and run some tests to determine whether your child is simply experiencing early onset puberty or whether he or she has CPP.

Keep in mind that children grow at different rates5

Children who are the same age will grow and develop at their own pace. Even large differences may be completely normal. Since girls usually go through puberty at a slightly younger age than boys, they are often taller than boys their own age during the early phases of puberty. Of course, girls and boys also develop other distinct differences throughout their puberty years.

Be sure to talk with your child's physician if you have any questions about your child's growth and development.

Have children been starting puberty at younger ages?1,3

You may have read that girls these days have been showing signs of puberty at younger ages. But the average age that girls have been getting their first periods has stayed around 12½ years old for over 50 years. The average age for the first sign of breast development has been getting younger, though. (Learn more about Puberty in Girls.)

Just because a child shows signs of puberty earlier than children in the past doesn't mean that he or she has CPP. Your child's physician will take many factors into consideration to determine the true cause of early onset puberty and whether treatment is necessary.

References: 1. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381. 2. Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008;358(22):2366-2377. 3. Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.com/health/precocious-puberty/DS00883. Accessed March 18, 2014. 4. Saenger P. Novel treatments seem promising for central precocious puberty. http://www.endocrinetoday.com/view.aspx?rid=26832. Accessed March 18, 2014. 5. Marshall WA, Tanner JM. Variations in pattern of pubertal changes in girls. Arch Dis Child. 1969;44:291-303.

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.