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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 DEPOT-PED.
LUPRON DEPOT-PED is not for children under 2 years of age.
View the full Prescribing Information for LUPRON DEPOT-PED.
Reference: LUPRON DEPOT-PED [package insert].
Talk to your child's doctor about your child's medical history and all other medicines that your child takes.
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.
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.
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.
Your child's initial response to LUPRON DEPOT-PED should be monitored, as well as their continued
response during treatment, as clinically needed.
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.
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 phone number (1-888-4PPA-NOW) for assistance.
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
LUPRON DEPOT-PED must be administered under the supervision of a physician.
Learning more about what to expect with LUPRON DEPOT-PED treatment is an important part of
preparing you and your child for CPP therapy. Be sure to put together a list of all the
questions you and your child have (both before starting therapy and while therapy is ongoing).
This list of questions can be a good
starting point. Remember, LUPRON DEPOT-PED must be administered under the supervision of a physician.
Know how your child should respond and what signs to look out for.
Keep track of pubertal development to help monitor how your child is responding to treatment.
Keeping up with therapy and monitoring progress are keys to effective treatment.
Learn how to answer your child’s questions about CPP and its treatment.
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.
Important Safety Information
Glossary of Terms
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