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.

Potential Complications of
Central Precocious Puberty (CPP)

Short-term and long-term consequences if CPP is left untreated

If CPP is left untreated, a child can continue to have pubertal changes as a result.¹ That’s why it’s so important to talk with your child’s physician as soon as you become concerned about the early signs of puberty you’re seeing.

Shorter adult height

At first, early puberty may cause a child to grow much taller than other kids their age. This accelerated growth is because in kids with CPP, bones mature earlier than they should due to 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 that cause puberty.²

But as bones mature, the growth plates in the bones start to close. And once growth plates fully close, bones can’t get any longer. When bones start to mature too early, growth can stop at an unusually early age. This can lead to a short adult height.²

CPP treatments like LUPRON DEPOT-PED can help delay puberty and stabilize growth until a more appropriate time in a child’s life.¹

References: 1. Kaplowitz PB. Precocious puberty [eMedicine from WebMd Web site]. Available at: http://www.emedicine.medscape.com/article/924002-print. Accessed March 29, 2011. 2. Carel JC, Lahlou N, Roger M, Chaussain JL. Precocious puberty and statural growth. Human Reproduction Update. 2004;10:135-147.

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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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