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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.

Frequently Asked Questions

About CPP

What is central precocious puberty (CPP)?
How do I know if my child has CPP?
What are the signs of CPP?
What causes CPP?
How is CPP diagnosed?

Treating CPP

What is a pediatric endocrinologist?
What should I ask the pediatrician or pediatric endocrinologist?
What is bone age and why is it important?
What could happen if my child is not treated for CPP?
What are the treatment options for CPP?
How do I talk with my child about CPP?

About LUPRON DEPOT-PED

What is LUPRON DEPOT-PED used for?
What is the generic name for LUPRON DEPOT-PED?
Who should not take LUPRON DEPOT-PED?
How does LUPRON DEPOT-PED work to treat CPP?
What does the term “depot” mean in LUPRON DEPOT-PED?
How is LUPRON DEPOT-PED administered?
How often does my child need to go to the doctor during LUPRON DEPOT-PED therapy?
Does LUPRON DEPOT-PED have any side effects?
How long will my child need to continue treatment with LUPRON DEPOT-PED?
How can I save on LUPRON DEPOT-PED?

About CPP

What is central precocious puberty (CPP)?1

Central precocious puberty (often shortened to “CPP” or “precocious puberty”) is a condition where puberty starts too soon in children—usually in girls under 8 years old and boys under 9 years old. (See What Is CPP?)

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How do I know if my child has CPP?1

A good first step is to become familiar with the normal changes in children to help you better understand your own child’s development. (See Signs and Symptoms of CPP)

If you start seeing early signs of pubertyPuberty: the period when a person begins to develop secondary sex characteristics and becomes capable of sexual reproduction in your child and you think he or she might have CPP, you should talk with your child’s physician. He or she may refer you to a pediatric endocrinologist (a doctor who specializes in hormonal problems in children). Only a physician can determine whether your child has CPP or is just in the early stages of normal puberty.

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What are the signs of CPP?1-3

The signs of CPP are similar to what children experience during normal puberty—it’s the timing that’s different. Some common signs that may occur with CPP include pubic hair growth and a sudden growth spurt.

Common signs of CPP in girls also include development of breast “buds,” menstrual periods, and/or underarm hair growth. Boys with CPP may also show signs of testicle or penis enlargement. (See Signs and Symptoms of CPP)

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What causes CPP?1

In most cases, there is no known 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 necessarily passed on from parents to children. Puberty just happens to be starting early for your child. Your child’s physician will conduct a thorough examination to determine whether there’s an underlying medical problem that might be causing signs of early puberty in your child. (See What Causes CPP?)

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How is CPP diagnosed?1

Your pediatrician (or pediatric endocrinologist if you have been referred to one) will ask a number of questions to get a medical history of your family and your child. He or she will conduct a physical exam. He or she will then run a series of tests, look at the results, and then make a diagnosis. (See How is CPP Diagnosed?)

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Treating CPP

What is a pediatric endocrinologist?

If your child’s physician thinks your child may have CPP, you may be referred to a pediatric endocrinologist, a doctor who specializes in the treatment of hormone-related conditions in children.

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What should I ask the pediatrician or pediatric endocrinologist?

Whether you suspect your child might be showing symptoms of CPP, or your child has already been diagnosed and you are considering treatment with LUPRON
DEPOT-PED
, you are sure to have questions for your doctor. See Talking With Your Child’s Physician for questions you can print out and bring with you to help start the conversation.

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What is bone age and why is it important?1,4

Bone ageBone age: the stage of development of the skeleton as compared with x-ray views of bone structures of other individuals who are the same age is a measurement of how mature a child’s bones are. It’s important to know bone age because it can help a doctor know if a child has CPP.

To determine bone age, an x-ray is taken of a child’s hand and wrist. Children have growth plates in bones such as the fingers and wrists. As a child grows, these growth plates eventually disappear. To help determine if a child has CPP, a doctor will look to see how much of a difference there is between a child’s real age and how mature the child’s bones are. (See How Is CPP Diagnosed?)

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What could happen if my child is not treated for CPP?

This is an important question to ask your child's physician. Every child is unique—your child’s history, symptoms, and age will be different from those of other children who are diagnosed with CPP. Only a physician will be able to gauge the long-term consequences for your child if CPP is left untreated. (See Potential Complications of CPP)

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What are the treatment options for CPP?1,5

If your child has been diagnosed with CPP, effective treatment options are available. Your pediatric endocrinologist may prescribe medicine to help stop or even reverse the signs and symptoms of puberty until a more appropriate age for puberty to start up again.

The most common treatment for CPP is called a gonadotropin-releasing hormone (GnRH) agonistGonadotropin-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). Pediatric endocrinologists will most often prescribe a GnRH agonist in the form of an injection like LUPRON DEPOT-PED. (See Treatment Options for CPP)

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How do I talk with my child about CPP?

Knowing how to talk to your child about CPP and answer his or her questions can go a long way toward helping to make your child feel more comfortable with the condition and its treatment. Take a look at ideas on how you can talk to your child about CPP and about LUPRON DEPOT-PED therapy.

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About LUPRON DEPOT-PED

What is LUPRON DEPOT-PED used for?1,5

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 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).

Back to top

What is the generic name for LUPRON DEPOT-PED?5

LUPRON DEPOT-PED is also known as leuprolide acetate for depot suspension.

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Who should not take LUPRON DEPOT-PED?

Children who are allergic to LUPRON DEPOT-PED or similar drugs or females who are or may become pregnant should not receive LUPRON DEPOT-PED. LUPRON DEPOT-PED is not for children under 2 years of age.

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How does LUPRON DEPOT-PED work to treat CPP?1,5

LUPRON DEPOT-PED works by suppressing the level of hormones that cause puberty. Stopping the production of these hormones delays puberty until a more appropriate time in your child’s life. (See How LUPRON DEPOT-PED Works)

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What does the term “depot” mean in LUPRON DEPOT-PED?6

"Depot" is a pharmacy term. It refers to a type of medicine that is formulated to be given as an intramuscular injection, but is absorbed by the body over a certain period of time (e.g., weeks or months).

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How is LUPRON DEPOT-PED administered?5

LUPRON DEPOT-PED is injected into the muscle every 4 weeks or every 12 weeks depending on the formulation your pediatric endocrinologist determines is right for your child. The pediatric endocrinologist may switch the injection site between the upper arm, buttocks, or thigh.

With multiple dosing options available, LUPRON DEPOT-PED allows for a treatment plan specific to your child’s needs. Your pediatric endocrinologist will determine the right dose for your child.

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How often does my child need to go to the doctor during LUPRON DEPOT-PED therapy?5

Your child's doctor will determine how often he or she needs to see your child. The doctor may take several factors into consideration, including how your child is responding to medication, side effects, additional tests, and the injection schedule.

LUPRON DEPOT-PED is given as an injection every 4 weeks (for monthly dosing) or every 12 weeks (for 3-month dosing). It is important that you keep your child’s doctor appointments and follow the prescribed injection schedule to make sure your child has the right amount of LUPRON DEPOT-PED in his or her body at all times. Your child’s pubertal development could begin again if injections are missed.

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 LUPRON DEPOT-PED.

Back to top

Does LUPRON DEPOT-PED have any side effects?5

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.

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.

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.

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.

Click here to see additional Important Safety Information you should know about LUPRON DEPOT-PED. You can also view the full Prescribing Information and talk with your doctor for more information.

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How long will my child need to continue treatment with LUPRON DEPOT-PED?

You should discuss with your pediatric endocrinologist at what point your child will be ready to stop LUPRON DEPOT-PED therapy. Your pediatric endocrinologist will discontinue LUPRON DEPOT-PED therapy at an appropriate age for your child.

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How can I save on LUPRON DEPOT-PED?

Learn how the Instant Savings Program for LUPRON DEPOT-PED can help you save money.

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References: 1. Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.com/health/precocious-puberty/DS00883. Accessed March 18, 2014. 2. Physical development, ages 11 to 14 years—topic overview. WebMD Web site. http://children.webmd.com/tc/physical-development-ages-11-to-14-years-topic-overview. Accessed March 18, 2014. 3. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381. 4. Carel JC, Léger J. Clinical practice. Precocious puberty. N Engl J Med. 2008;358(22):2366-2377. 5. LUPRON DEPOT-PED [package insert]. 6. Dorland’s Illustrated Medical Dictionary. 32nd ed. Philadelphia, Pa: Elsevier; 2011

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.