Use and Important Safety Information You Should Know About Lupron Depot‑PED^® (leuprolide acetate for depot suspension)

Use

LUPRON DEPOT‑PED^® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg and 15 mg 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. Doctors will also perform tests to rule out possible causes of CPP that would require different treatment (e.g., tumors).

Important Safety Information

Your child should not receive LUPRON DEPOT‑PED if he/she has experienced any type of allergic reaction to LUPRON DEPOT, or similar drugs.

Females who may be pregnant, are breast-feeding, or have undiagnosed vaginal bleeding should not receive LUPRON DEPOT‑PED.

After starting LUPRON DEPOT‑PED therapy, your child may experience increased signs and symptoms of CPP during the first few weeks of treatment.

You should notify the doctor if your child has menstrual bleeding that continues beyond the second month of treatment, has irritation at the injection site, develops mood swings or behavioral changes, or has any other unusual signs or symptoms.

It is important that you keep your child’s doctor appointments. If your child misses a shot or is a week late, your child’s pubertal development could begin again.

Response to LUPRON DEPOT‑PED should be monitored 1-2 months after the start of therapy to determine if your child’s current dose is at the right level. You should know that your doctor should also be measuring your child’s bone age every 6-12 months.

Studies have not been completed in children to determine the full reversibility of fertility suppression.

The most common side effects of LUPRON DEPOT‑PED include injection site reactions including abscess, general pain, acne, rash and vaginitis/vaginal bleeding or discharge.

LUPRON DEPOT‑PED must be administered under the supervision of a physician.

This is the most important information to know about LUPRON DEPOT‑PED. For more information, talk with your child’s health care provider.

Reference: LUPRON DEPOT‑PED [package insert]. North Chicago, IL: Abbott Laboratories.

Please see the full Prescribing Information for Lupron Depot‑PED.