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 (e.g., tumors).
It is not known if LUPRON DEPOT-PED is safe and effective in children under 2 years of age.
Important Safety Information for LUPRON DEPOT-PED
What is the most important information I should know about LUPRON DEPOT-PED?
Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems while taking LUPRON DEPOT-PED.
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 should not be taken if your child is:
Before your child receives LUPRON DEPOT-PED, tell your doctor about all of your child’s medical conditions, including if they:
Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will your child receive LUPRON DEPOT-PED?
What are the common side effects of LUPRON DEPOT-PED?
These are not all the possible side effects of LUPRON DEPOT-PED. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1‑800‑FDA‑1088.
This is the most important information to know about LUPRON
DEPOT-PED. For more information, talk to your doctor or healthcare
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