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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.

Treatment Options for
Central Precocious Puberty (CPP)

Which CPP treatment is best for your child?1

Your pediatric endocrinologist is the best authority on determining how and when to treat CPP. The medicine he or she prescribes can help slow or even stop the signs and symptoms of puberty until a more appropriate age for puberty to start up again.

However, you should also learn as much as possible about the different types of treatments for CPP, because it can help you and your child prepare for the treatment process. After reviewing all of the options, you should discuss them with your pediatric endocrinologist. Once your child begins treatment, he or she will need to be monitored to make sure the medication is working. Part of successful treatment is keeping your child's appointments for medication and monitoring.

Treating CPP with GnRH agonists1-3

The most common treatment for CPP is called a gonadotropin-releasing hormone (GnRH) agonistGonadotropin-releasing hormone (GnRH) agonist: The most common treatment for CPP. GnRH agonists work by making sure the pituitary gland stops sending hormones to stimulate the ovaries and testes to produce sex hormones. GnRH agonists work by making sure the pituitary glandPituitary gland: a small gland located at the base of the brain that helps control the release of hormones ignores signals from the hypothalamusHypothalamus: a part of the brain that regulates a number of basic body functions, like temperature, sleep, food intake, and the development of secondary sex characteristics. The pituitary gland stops sending 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 to stimulate the ovaries and testes to produce sex hormones. (For a discussion of how hormones trigger puberty, see how puberty begins.)

GnRH agonists are used to delay the puberty process. Once your pediatric endocrinologist decides that your child is a more appropriate age, he or she will stop GnRH agonist therapy, and the puberty process will start back up again.

Types of GnRH agonists1,2-6

LUPRON DEPOT-PED is the GnRH agonist most often prescribed in the US.* It’s given in the form of an injection on a routine basis, allowing your pediatric endocrinologist to monitor your child at regular intervals and adjust dosing when needed. LUPRON DEPOT-PED is available in both 3-month and
1-month dosing options
.

When considering treatments, it’s important to discuss with your pediatric endocrinologist which type of treatment will work best for you and your child, as well as any possible side effects that can happen with CPP therapy.

During the first weeks of treatment with a GnRH agonist like LUPRON DEPOT-PED, an increase in the signs of puberty (like vaginal bleeding) may occur. This is a common initial effect of the drug—your child will experience an increase in puberty-causing hormones before they start decreasing. Call your pediatric endocrinologist if these symptoms continue beyond the second month of treatment.

Monitoring your child’s progress4

In addition to monitoring your child during the first month, you may want to track how your child is progressing throughout therapy. Using a Progress Tracker like this one for LUPRON DEPOT-PED can help you keep track of your child’s pubertal development.

Your pediatric endocrinologist will probably want to monitor your child to see how he or she is responding to treatment. Monitoring is especially important during the first 6–8 weeks of treatment to make sure the medicine is working the way it’s supposed to and your child is receiving and responding to the lowest effective dose. Your pediatric endocrinologist will also probably want to monitor your child’s growth rate and bone age every 3–6 months or so after treatment starts.

*Based on IMS Health, DDD, and NDCHealth®, NDC Non-Retail.

References: 1. Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.com/health/precocious-puberty/DS00883. Accessed March 18, 2014. 2. Saenger P. Novel treatments seem promising for central precocious puberty. http://www.endocrinetoday.com/view.aspx?rid=26832. Accessed March 18, 2014. 3. Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008;358(22):2366-2377. 4. LUPRON DEPOT-PED [package insert]. 5. Supprelin® LA (histrelin acetate) prescribing information. Endo Pharmaceuticals. 6. Synarel® (nafarelin acetate) prescribing information. Pfizer Inc.

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.