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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.

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 options to treat CPP.

Safety Considerations: 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 regularly2

Every child’s needs are unique. Since LUPRON DEPOT-PED is given on a routine basis (either monthly or every 3 months), 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.

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 treatment2

LUPRON DEPOT-PED is a treatment for CPP that offers multiple dosing options 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 Considerations: • Your child should not receive LUPRON DEPOT-PED if she/he is allergic to any of the ingredients or she is or may become pregnant. • Increased signs and symptoms of puberty during the first few weeks of treatment may occur. • Contact your child’s healthcare provider if signs of puberty continue after the second month of treatment or if new or unusual signs or symptoms occur.
• Mental (psychiatric) problems have been reported in patients taking GnRH agonists, like LUPRON DEPOT-PED. Events include emotional symptoms such as crying, irritability, restlessness (impatience), anger, and acting aggressive. • Inform your child’s doctor right away if your child has any new or worsening mood symptoms while taking LUPRON DEPOT-PED. • Seizures have been observed in patients taking GnRH agonists, like LUPRON DEPOT-PED, with or without a history of seizures, epilepsy, brain or brain vessel problems or tumors, and in patients taking medications that have been connected to seizures. • Call your child's doctor right away if your child has a seizure while taking LUPRON DEPOT-PED. • Your child’s pubertal development could begin again if the injection schedule is not followed.

*Based on IMS Health, DDD, and NDCHealth®, NDC Non-Retail.

References: 1. Data on file, AbbVie Inc. 2. LUPRON DEPOT-PED [package insert].

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.