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]. North Chicago, IL: Abbott Laboratories.

202-653313
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]. North Chicago, IL: Abbott Laboratories.

202-653313
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]. North Chicago, IL: Abbott Laboratories.

202-653313
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]. North Chicago, IL: Abbott Laboratories.

202-653313
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 (1-888-4PPANOW) for assistance.

View the full Prescribing Information for LUPRON DEPOT-PED.

Reference: LUPRON DEPOT-PED [package insert]. North Chicago, IL: Abbott Laboratories.

202-653313

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 CPP that would require different treatment (e.g., tumors).

LUPRON DEPOT-PED must be administered under the supervision of a physician.

What causes Central Precocious Puberty (CPP)?

The cause of CPP is unknown

In most cases, there is no special reason for your child’s early development. It is not caused by anything you do or have done in the past, and it’s not passed on from parents to children. PubertyPuberty: the period when a person begins to develop secondary sex characteristics and becomes capable of sexual reproduction just happens to be starting early for your child.¹

CPP is less common in boys. When they show signs of precocious puberty, boys are more likely to have a different medical problem that’s causing their early puberty.¹ Your child’s physician will conduct a thorough examination, including an MRI or CT scan, to determine if your child’s early development is due to CPP or if there might be an underlying medical problem.²

How puberty begins

Puberty normally begins in girls between the ages of 8 and 12 and in boys between the ages of 9 and 13. The signs are the same as those you see for CPP, but they’re triggered earlier than normal.¹ Here’s how normal puberty happens:

When a child’s body is ready to begin puberty, 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 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 called gonadotropin-releasing hormone (GnRH)Gonadotropin-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..^1,3
This hormone causes the pituitary gland (a small gland at the base of the brain) 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 folliclestimulating 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.^1,3
LH and FSH stimulate the ovaries to produce estrogen in girls and the testicles to produce testosterone in boys—which lead to the changes you see during puberty.^1,3

In children with CPP, the hypothalamus releases GnRH earlier than normal, triggering the release of puberty-causing hormones.¹ Medicines like LUPRON DEPOT-PED work to suppress the natural GnRH hormone. This interrupts the release of the hormones that cause puberty until a more appropriate time for puberty to occur.^2,4

Due to an initial increase in the release of puberty-causing hormones, an increase in the signs of puberty may occur during the first weeks of treatment. This is a common initial effect of the drug. Your child's doctor should be notified if signs/symptoms of puberty continue beyond the second month of treatment with LUPRON DEPOT-PED.

References: 1. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381. 2. Kaplowitz PB. Precocious puberty [eMedicine from WebMd Web site]. Available at: http://www.emedicine.medscape.com/article/924002-print. Accessed March 29, 2011. 3. Blondell RD, et al. Disorders of Puberty. Am Fam Physician. 1999;60:209-224. 4. LUPRON DEPOT-PED [package insert]. North Chicago, IL: Abbott Laboratories.

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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.

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What causes Central Precocious Puberty (CPP)?

The cause of CPP is unknown

How puberty begins