Lupron Depot Pediatric (Leuprolide Acetate Injection) Drug Information: Medication Guide and Patient Information

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May 27, 2012

Lupron Pediatric

Endometriosis »

What is endometriosis?

Endometriosis is the abnormal growth of cells (endometrial cells) similar to those that form the inside of the uterus, but in a location outside of the uterus. Endometrial cells are cells that are shed each month during menstruation. The cells of endometriosis attach themselves to tissue outside the uterus and are called endometriosis implants. These implants are most commonly found on the ovaries, the Fallopian tubes, outer surfaces of the uterus or intestines, and on the surface lining of the pelvic cavity. They can also be found in the vagina, cervix, and bladder, although less commonly than other locations in the pelvis. Rarely, endometriosis implants can occur outside the pelvis, on the liver, in old surgery scars, and even in or around the lung or brain. Endometrial implants, while they can cause problems, are benign (not cancerous).

Who is affected by endometriosis?

Endometriosis affects w...

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Lupron Depot Pediatric

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PATIENT INFORMATION

Prior to starting therapy with LUPRON DEPOT-PED, patients should be informed that:

All formulations are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential risk to the fetus.
Continuous therapy is important and that adherence to a monthly drug administration schedule must be accepted if therapy is to be successful. If the monthly injection schedule is not followed, pubertal development may begin again.
During the first weeks of treatment, signs of puberty, e.g., vaginal bleeding, may occur. This is a common initial effect of the drug. If these symptoms continue beyond the second month of treatment, the physician should be notified.
The most common side effects related to treatment with 1-month or 3-month LUPRON DEPOT-PED in clinical studies are: pain, acne/seborrhea, injection site reactions including pain, swelling and abscess, rash including erythema multiforme, vaginitis/bleeding/discharge, increased weight, headache, and altered mood.
After injection, some pain and irritation is expected; however if more severe symptoms occur, the physician should be contacted. Any unusual signs or symptoms should be reported to the physician.