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.

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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.

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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.

Treating with LUPRON DEPOT-PED

LUPRON DEPOT-PED is the #1 prescribed treatment for CPP¹

Since 1993 doctors have prescribed LUPRON DEPOT-PED more than any other CPP treatment.* It was the first depot injection available to treat CPP and is the first and only depot injection product to offer multiple dosing options¹ to treat CPP.

Safety Fact: LUPRON DEPOT-PED should not be used in girls who are or may become pregnant. If she becomes pregnant while taking the drug, your doctor should explain the potential of risk to the fetus. LUPRON DEPOT-PED should also not be used in children who are allergic to LUPRON DEPOT-PED or any of its ingredients.

Routine dosing: customizing the length of therapy and monitoring regularly

Every child’s needs are unique. Since LUPRON DEPOT-PED is given on a routine basis (either monthly or every 3 months)², your pediatric endocrinologistPediatric endocrinologist: a doctor who specializes in the treatment of hormone-related conditions in children can customize a treatment plan based on a specific number of months. And regular visits allow the pediatric endocrinologist to monitor your child’s progress and adjust the dosage if needed.

Your pediatric endocrinologist will most likely want to monitor your child’s response to treatment 1–2 months (for monthly dosing) or 2–3 months (for 3-month dosing) after starting therapy to assess the hormonal response. The doctor will also most likely want to measure your child’s bone age every 6–12 months.²

Your pediatric endocrinologist will discontinue LUPRON DEPOT-PED treatment when your child is at an appropriate age to resume puberty.

LUPRON DEPOT-PED offers a range of dosing options for customized treatment

LUPRON DEPOT-PED is the only treatment for CPP that offers multiple dosing options² to help your child’s physician customize treatment for your child. With a number of dosing options to choose from, your doctor can make sure your child gets the right dosage. And with ongoing monitoring, your doctor has the flexibility to choose a different dose if needed.

Your child’s pediatric endocrinologist will individualize the LUPRON DEPOT-PED dose for your child. If hormone and clinical suppression are not achieved with the starting dose, the doctor may need to adjust the dosage level. The dose may also need to be adjusted as your child’s body weight changes.

Together, the ability to:

monitor your child on a regular basis
treat your child in terms of months and
choose from a number of dosing options

helps your doctor create a customized treatment plan that’s right for your child’s individual needs—the right amount of medicine for the right number of months.

Safety Fact: After injection, some pain and irritation is expected; however if more severe symptoms occur, the physician should be contacted. The most common side effects with LUPRON DEPOT-PED include: 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.

*Based on IMS Health, DDD™, and NDCHealth®, NDC Non-Retail™, September 2007, for the US market.

References: 1. Data on file. 2. 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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