Use and Important Safety Information1
Use for LUPRON DEPOT-PED®
(leuprolide acetate for depot suspension)
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
Important Safety Information for LUPRON DEPOT-PED
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
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.
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.
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.
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.
LUPRON DEPOT-PED is not for children under 2 years of age.
LUPRON DEPOT-PED must be administered under the supervision of a physician.
For more information, talk with your child’s healthcare provider.
Please see the full Prescribing Information for LUPRON DEPOT-PED.