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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.

How is Central Precocious
Puberty (CPP) Diagnosed?

Medical history and physical exam1

In order to diagnose your child for CPP, your child’s physician will first ask you a number of questions to get a medical history of your family and your child. Questions may include things like:

  1. What signs of puberty have you noticed?
  2. When did you first start noticing them?
  3. How fast have they been progressing?
  4. Does your family have a history of early puberty?

To rule out other medical problems that could be causing signs of early puberty, the physician will also ask whether your child has had any other pains or problems. He or she will then conduct a detailed physical examination.

Tests to help diagnose CPP1,2

If the physician thinks CPP might be causing your child’s early puberty, he or she may refer you to a pediatric endocrinologistPediatric endocrinologist: a doctor who specializes in the treatment of hormone-related conditions in children to conduct a number of tests and make an official diagnosis. Pediatric endocrinologists specialize in the treatment of hormone-related conditions in children.

Your child’s physician or pediatric endocrinologist may perform a series of tests:

  • An x-ray of the hand and wrist. An x-ray of your child’s hands and wrists can help determine your child’s bone ageBone age: the stage of development of the skeleton as compared with x-ray views of bone structures of other individuals who are the same age (a measure of how mature his or her bones are). Because the bones of prepubertal children have growth plates in their wrists and fingers that disappear as a child ages, a bone age test can help the physician compare your child’s actual age (where he or she should be on a standard growth chart) with his or her bone age. The physician can then determine whether the bones are growing too quickly.
  • A blood test. This measures the level of hormones in your child’s bloodstream.
  • A GnRH stimulation test. This test confirms that your child’s symptoms are caused by CPP.
  • A pelvic and adrenal ultrasound. This will show the current state of development of your child’s ovaries, adrenal glands, and testicles.
  • A magnetic resonance imaging (MRI) or computed tomography (CT) scan. These scans are used to rule out other causes of early puberty.

After the physician looks at the results of these tests, he or she will make a proper diagnosis. If your child is diagnosed with CPP, the physician may prescribe a treatment like LUPRON DEPOT-PED. (See Treatment Options for CPP)

References: 1. Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.com/health/precocious-puberty/DS00883. Accessed March 18, 2014. 2. Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008;358(22):2366-2377.

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.