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2016705-1912566

  • Do Not Take If

    LUPRON DEPOT-PED should not be taken if your child is:

    • Allergic to GnRH, GnRH agonist medicines, or any ingredients in LUPRON DEPOT-PED.

    • Pregnant or becomes pregnant. LUPRON DEPOT-PED can cause birth defects or loss of the baby. If your child becomes pregnant, call your doctor.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert].

  • Before Starting

    Before your child receives LUPRON DEPOT-PED, tell your doctor about all of your child’s medical conditions, including if they:

    • Have a history of mental (psychiatric) problems

    • Have a history of seizures

    • Have a history of epilepsy

    • Have a history of brain or brain vessel (cerebrovascular) problems or tumors

    • Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

    • Are breastfeeding or plan to breastfeed. It is not known if LUPRON DEPOT-PED passes into the breast milk.

    Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert].

  • What to Expect

    What is the most important information I should know about LUPRON DEPOT-PED?

    • During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones.
      During this time, you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED.

    • Some people taking gonadotropin-releasing hormone (GnRH) agonists like LUPRON DEPOT-PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:

      • Crying
      • Irritability
      • Restlessness (impatience)
      • Anger
      • Acting aggressive

    Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRON DEPOT-PED.

    • Some people taking GnRH agonists like LUPRON DEPOT-PED have had seizures. The risk of seizures may be higher in people who:

      • Have a history of seizures
      • Have a history of epilepsy
      • Have a history of brain or brain vessel (cerebrovascular) problems or tumors
      • Are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

    Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking LUPRON DEPOT-PED.

    • LUPRON DEPOT-PED is injected into your child’s muscle by a doctor or trained nurse.

    View the full Prescribing Information for LUPRON DEPOT-PED.

    Reference: LUPRON DEPOT-PED [package insert].

  • Side Effects
    • The most common side effects of LUPRON DEPOT-PED received 1 time each month include:

      • Injection site reactions such as pain, swelling, and abscess
      • Weight gain
      • Pain throughout body
      • Headache
      • Acne or red, itchy rash and white scales (seborrhea)
      • Serious skin rash (erythema multiforme)
      • Mood changes
      • Swelling of vagina (vaginitis), vaginal bleeding, and vaginal discharge
    • The most common side effects of LUPRON DEPOT-PED received every 3 months include:

      • Injection site pain
      • Weight gain
      • Headache
      • Mood changes
      • Injection site swelling

    These are not all the possible side effects of LUPRON DEPOT-PED. Call your doctor for medical advice about side effects.

    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.

    This is the most important information to know about LUPRON DEPOT-PED. For more information, talk to your doctor or healthcare provider.

    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).

It is not known if LUPRON DEPOT-PED is safe and effective in children under 2 years of age.

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 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).

It is not known if LUPRON DEPOT-PED is safe and effective in children under 2 years of age.

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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.

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Does LUPRON DEPOT-PED have any side effects?5

  • During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED.
  • Some people taking gonadotropin-releasing hormone (GnRH) agonists like LUPRON DEPOT-PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as:
    • Crying
    • Irritability
    • Restlessness (impatience)
    • Anger
    • Acting aggressive

Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRON DEPOT-PED.

  • Some people taking GnRH agonists like LUPRON DEPOT-PED have had seizures. The risk of seizures may be higher in people who:
    • Have a history of seizures
    • Have a history of epilepsy
    • Have a history of brain or brain vessel (cerebrovascular) problems or tumors
    • Are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs)

Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking LUPRON DEPOT-PED.

  • The most common side effects of LUPRON DEPOT-PED received 1 time each month include:
    • Injection site reactions such as pain, swelling, and abscess
    • Weight gain
    • Pain throughout body
    • Headache
    • Acne or red, itchy rash and white scales (seborrhea)
    • Serious skin rash (erythema multiforme)
    • Mood changes
    • Swelling of vagina (vaginitis), vaginal bleeding, and vaginal discharge
  • The most common side effects of LUPRON DEPOT-PED received every 3 months include:
    • Injection site pain
    • Weight gain
    • Headache
    • Mood changes
    • Injection site swelling

These are not all the possible side effects of LUPRON DEPOT-PED. Call your doctor for medical advice about side effects.

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.