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2016705-1912566

  • Do Not Take If

    LUPRON DEPOT-PED should not be taken if your child is:

    • Allergic to GnRH, GnRH agonist medicines, or any ingredients in LUPRON DEPOT-PED.

    • Pregnant or becomes pregnant. LUPRON DEPOT-PED can cause birth defects or loss of the baby. If your child becomes pregnant, call your doctor.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert].

  • Before Starting

    Before your child receives LUPRON DEPOT-PED, tell your doctor about all of your child’s medical conditions, including if they:

    • Have a history of mental (psychiatric) problems

    • Have a history of seizures

    • Have a history of epilepsy

    • Have a history of brain or brain vessel (cerebrovascular) problems or tumors

    • Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

    • Are breastfeeding or plan to breastfeed. It is not known if LUPRON DEPOT-PED passes into the breast milk.

    Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert].

  • What to Expect

    What is the most important information I should know about LUPRON DEPOT-PED?

    • During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones.
      During this time, you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED.

    • Some people taking gonadotropin-releasing hormone (GnRH) agonists like LUPRON DEPOT-PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:

      • Crying
      • Irritability
      • Restlessness (impatience)
      • Anger
      • Acting aggressive

    Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRON DEPOT-PED.

    • Some people taking GnRH agonists like LUPRON DEPOT-PED have had seizures. The risk of seizures may be higher in people who:

      • Have a history of seizures
      • Have a history of epilepsy
      • Have a history of brain or brain vessel (cerebrovascular) problems or tumors
      • Are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

    Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking LUPRON DEPOT-PED.

    • LUPRON DEPOT-PED is injected into your child’s muscle by a doctor or trained nurse.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert].

  • Side Effects
    • The most common side effects of LUPRON DEPOT-PED received 1 time each month include:

      • Injection site reactions such as pain, swelling, and abscess
      • Weight gain
      • Pain throughout body
      • Headache
      • Acne or red, itchy rash and white scales (seborrhea)
      • Serious skin rash (erythema multiforme)
      • Mood changes
      • Swelling of vagina (vaginitis), vaginal bleeding, and vaginal discharge
    • The most common side effects of LUPRON DEPOT-PED received every 3 months include:

      • Injection site pain
      • Weight gain
      • Headache
      • Mood changes
      • Injection site swelling

    These are not all the possible side effects of LUPRON DEPOT-PED. Call your doctor for medical advice about side effects.

    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.

    This is the most important information to know about LUPRON DEPOT-PED. For more information, talk to your doctor or healthcare provider.

    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).

It is not known if LUPRON DEPOT-PED is safe and effective in children under 2 years of age.

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.