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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 LUPRON DEPOT-PED Works

LUPRON DEPOT-PED suppresses puberty-causing hormones1-3

LUPRON DEPOT-PED belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) agonistsGonadotropin-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. This drug is similar to GnRHGonadotropin-releasing hormone (GnRH): a hormone made by the hypothalamus (part of the brain) that causes the pituitary gland (a small gland at the base of the brain) to release two other hormones: luteinizing hormone (LH) and follicle-stimulating hormone (FSH), a hormoneHormone: 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 made naturally by your body.

When a child’s body is ready to begin pubertyPuberty: the period when a person begins to develop secondary sex characteristics and becomes capable of sexual reproduction, a part of the brain called 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 releases GnRH. GnRH causes the pituitary glandPituitary gland: a small gland located at the base of the brain that helps control the release of hormones to release two other hormones: luteinizing hormone (LH)Luteinizing hormone (LH): a hormone released by the pituitary gland that stimulates the ovaries to produce estrogen and the testicles to produce testosterone—which lead to the changes you see during puberty and follicle-stimulating hormone (FSH)Follicle-stimulating hormone (FSH): a hormone released by the pituitary gland that stimulates the ovaries to produce estrogen and the testicles to produce testosterone—which lead to the changes you see during puberty. LH and FSH stimulate the ovaries to produce estrogenEstrogen: female sex hormone responsible for the development of secondary sex characteristics and involved in the reproductive cycle in women or the testicles to produce testosteroneTestosterone: male sex hormone (a small amount is produced by females as well) that is responsible for producing masculine secondary sex characteristics such as growth of body hair and the development of the male reproductive system.—which leads to the changes you see during puberty. In children with central precocious puberty (CPP), this process happens earlier than normal.

LUPRON DEPOT-PED works by suppressing the natural GnRH hormone. This interrupts the release of the hormones that cause puberty, until it is a more appropriate time for puberty to occur.

Safety Considerations: During the first weeks of treatment, an increase in the signs of puberty may occur. This is a common initial effect of the drug. LUPRON DEPOT-PED can also cause unintended side effects including general pain; acne; injection site reactions including pain, swelling, and abscess; rash including a rash with fever and blister-like bumps; vaginitis/vaginal bleeding/vaginal discharge; increased weight; headache; and changes in mood. Talk with your doctor about all the benefits and risks when deciding if LUPRON DEPOT-PED is right for your child.

When LUPRON DEPOT-PED therapy stops, puberty starts back up1

Your pediatric endocrinologist will monitor your child’s progress during therapy. When the pediatric endocrinologist decides that it’s a more appropriate time for puberty to continue, he or she will discontinue treatment, and the puberty-causing hormones will no longer be suppressed. Normal puberty development will then start back up.

References: 1. LUPRON DEPOT-PED [package insert]. 2. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381.
3. Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.com/health/precocious-puberty/DS00883. Accessed March 18, 2014.

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.