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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.

How LUPRON DEPOT-PED Works

LUPRON DEPOT-PED suppresses puberty-causing hormones1-3

LUPRON DEPOT-PED belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) agonistsGonadotropin-releasing hormone (GnRH) agonist: The most common treatment for CPP. GnRH agonists work by making sure the pituitary gland stops sending hormones to stimulate the ovaries and testes to produce sex hormones. This drug is similar to GnRHGonadotropin-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), a hormoneHormone: 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 made naturally by your body.

When a child’s body is ready to begin pubertyPuberty: the period when a person begins to develop secondary sex characteristics and becomes capable of sexual reproduction, a part of the brain called the hypothalamusHypothalamus: a part of the brain that regulates a number of basic body functions, like temperature, sleep, food intake, and the development of secondary sex characteristics releases GnRH. GnRH causes the pituitary glandPituitary gland: a small gland located at the base of the brain that helps control the release of hormones to release two other hormones: luteinizing hormone (LH)Luteinizing hormone (LH): a hormone released by the pituitary gland that stimulates the ovaries to produce estrogen and the testicles to produce testosterone—which lead to the changes you see during puberty and follicle-stimulating hormone (FSH)Follicle-stimulating hormone (FSH): a hormone released by the pituitary gland that stimulates the ovaries to produce estrogen and the testicles to produce testosterone—which lead to the changes you see during puberty. LH and FSH stimulate the ovaries to produce estrogenEstrogen: female sex hormone responsible for the development of secondary sex characteristics and involved in the reproductive cycle in women or the testicles to produce testosteroneTestosterone: male sex hormone (a small amount is produced by females as well) that is responsible for producing masculine secondary sex characteristics such as growth of body hair and the development of the male reproductive system.—which leads to the changes you see during puberty. In children with central precocious puberty (CPP), this process happens earlier than normal.

LUPRON DEPOT-PED works by suppressing the natural GnRH hormone. This interrupts the release of the hormones that cause puberty, until it is a more appropriate time for puberty to occur.

Safety Considerations: During the first weeks of treatment, an increase in the signs of puberty may occur. This is a common initial effect of the drug. LUPRON DEPOT-PED can also cause unintended side effects including 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. Talk with your doctor about all the benefits and risks when deciding if LUPRON DEPOT-PED is right for your child.

When LUPRON DEPOT-PED therapy stops, puberty starts back up1

Your pediatric endocrinologist will monitor your child’s progress during therapy. When the pediatric endocrinologist decides that it’s a more appropriate time for puberty to continue, he or she will discontinue treatment, and the puberty-causing hormones will no longer be suppressed. Normal puberty development will then start back up.

References: 1. LUPRON DEPOT-PED [package insert]. 2. Muir A. Precocious puberty. Pediatr Rev. 2006;27:373-381.
3. Precocious puberty. Mayo Clinic Web site. http://www.mayoclinic.com/health/precocious-puberty/DS00883. Accessed March 18, 2014.

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.