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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.

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.