ABOUT LUPRON DEPOT-PED
LUPRON DEPOT-PED helps control Central Precocious Puberty (CPP)
LUPRON DEPOT-PED is:
- A gonadotropin-releasing hormone agonist, or GnRHa. It works by helping the pituitary gland ignore signals from the brain, which pauses the release of sex hormones that cause puberty while children are on treatment
- An intramuscular injection administered at the doctor’s office
In a study of 1-month dosing, LUPRON DEPOT-PED provided control by pausing early puberty within 4 weeks†
96.4% of children achieved suppression of a reproductive hormone.‡ Suppression means either pausing puberty with no changes or reversing the signs of puberty.
†55 children (49 females and 6 males) with CPP were treated with LUPRON DEPOT-PED for an average of 3.9 years, who were then followed after treatment for an average of 3.5 years.
‡Mean peak luteinizing hormone.
While on treatment, your child’s physical signs of early puberty should be paused. Genital and breast development should stop or reverse. Your child’s growth should slow down to a rate that is normal for their age.
- During 5 years of treatment, 66.7%-90.6% of females had suppression of breast development
- During 5 years of treatment, 60%-100% of males had suppression of genitalia development
In nearly 9 out of 10 children taking LUPRON DEPOT-PED 1-month dosing, reproductive hormones returned to puberty levels within 6 months of stopping treatment.
LUPRON DEPOT-PED was studied as a 6-month, 3-month, and 1-month dosing schedule. All dosing schedules provided sustained suppression of early puberty.
Talk to your child's doctor about what dose and schedule is best for you.
LUPRON DEPOT-PED can help control your child’s CPP
Talk to your child’s pediatric endocrinologist about when it's appropriate for your child to start and stop treatment.
The pediatric endocrinologist can help decide what treatment plan may work best for your child’s specific needs.
LONG-TERM EFFICACY AND SAFETY DATA
LUPRON DEPOT-PED is the ONLY CPP treatment that has a long‑term, 18-year efficacy and safety study
The study included a posttreatment follow-up period to assess reproductive function in females
Patients were treated with LUPRON DEPOT-PED 1-month and followed into adulthood (age 21)
After treatment, the reproductive development of 20 patients aged 18-26 was evaluated:
80% (16 of 20) reported normal menstrual cycles§
12 pregnancies in 7 patients (including multiple pregnancies in 4 patients)
4 of 4 women who tried to become pregnant did
§According to the Office on Women's Health, this is similar to women in the United States, with up to 86% having regular bleeding during their childbearing years.
On average, children on LUPRON DEPOT-PED grew taller than the height predicted for them when they were first diagnosed with CPP.
DOSING OPTIONS
Every child has unique needs, including the amount of medicine needed to treat their CPP
ONLY LUPRON DEPOT-PED offers flexible dosing for 6-, 3-, and 1-month options using the thinnest needle for CPP injections
Your child's doctor can create a treatment plan specifically for your child. This will ensure they get the right amount of medicine throughout their treatment.
| DOSING |
|---|
| 3-month dosing |
| 11.25 mg and 30 mg |
| 4 injections each year |
| 1-month dosing |
| 7.5 mg, 11.25 mg, and 15 mg |
| 12 injections each year |
| 6-month dosing |
|
| 3-month dosing |
|
| 1-month dosing |
|
Only LUPRON DEPOT-PED has 6 dosing options
How the dosing options work
- Your child’s doctor decides on the appropriate starting dose for your child
- The doctor checks hormone levels at the appropriate time based on the dosing schedule
- If the hormone levels are reduced, the doctor may change how often your child gets an injection
- If the hormone levels are not reduced, the doctor may change how much medicine is given and/or how often your child gets an injection
Your child’s pediatric endocrinologist will monitor your child’s progress. If hormone and clinical suppression are not achieved with the starting dose, they may need to adjust the dose. The dose may also need to be adjusted as your child’s body weight changes.
WHY LUPRON DEPOT-PED?
The #1 prescribed treatment for CPPII
- Over 30 years of clinical experience, with a proven efficacy and safety profile¶
- 18+ year long-term efficacy and safety study, including a posttreatment follow-up period to assess reproductive function in females for LUPRON DEPOT-PED 1-month
- 1 brand with 6 dosing options (6-month, 3-month, and 1-month) to allow the flexibility to individualize treatment
- The thinnest needle for CPP injections
IIData sourced as of September 2025.
¶FDA approved in 1993.
COMMON SIDE EFFECTS
Your healthcare team will assess your child for any side effects of treatment with LUPRON DEPOT-PED
Possible side effects of LUPRON DEPOT-PED
It’s important to notify your child’s pediatrician or pediatric endocrinologist right away if your child experiences any side effects from therapy.
In clinical studies, the most common side effects of LUPRON DEPOT-PED included:
6-month dosing:
- Injection site reactions# such as pain and swelling
- Headache
- Mood changes
- Upper stomach pain
- Diarrhea
- Bleeding
- Nausea and vomiting
- Fever
- Itching
- Pain in extremities
- Rash
- Back pain
- Ligament sprain
- Weight gain
- Fracture
- Breast tenderness
- Difficulty sleeping
- Chest pain
- Excessive sweating
3-month dosing:
- Injection site reactions# such as pain and swelling
- Weight gain
- Headache
- Mood changes
1-month dosing:
- 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, vaginal discharge
Ask your child’s doctor about possible side effects with LUPRON DEPOT-PED
#After the injection, some pain and/or irritation may occur. However, if these symptoms get worse or persist, or if any new or unusual symptoms develop, call your child's doctor.
See additional Important Safety Information you should know about LUPRON DEPOT-PED.
You can also view the full Prescribing Information and talk with your child's doctor for more information.
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