Leuprolide Acetate Depot-PED, Injection

What are other names for this medicine?

Type of medicine: gonadotropin-releasing hormone analog

leuprolide acetate depot-PED, injection; Lupron Depot-PED

What is this medicine used for?

This medicine is given by injection (shots) to treat central precocious puberty (when a child start to mature too early in life).

What should my healthcare provider know before my child takes this medicine?

Before taking this medicine, tell your healthcare provider if your child have ever had:

• an allergic reaction to any medicine or hormone, or to benzyl alcohol
• a stroke
• abnormal vaginal bleeding
• blood clots or a bleeding disorder such as anemia
• cancer in the spine
• depression
• heart problems
• bone thinning
• problems with drug or alcohol abuse
• trouble urinating

Females of childbearing age: Do not use this medicine if you are pregnant because it may cause a miscarriage or may seriously harm the baby. Do not breast-feed while receiving this medicine.

How do I use it?

These shots are usually given by a healthcare provider every 4 weeks. The dosage is determined by the child's weight. Your healthcare provider will order some tests to see how well the medicine is working and may adjust the dosage. The medicine is in depot form, which means that it is released slowly during the 4 weeks. This medicine should be discontinued before age 11 years in females and 12 years in males.

What should I watch out for?

During the first 2 months of treatment, females may experience vaginal bleeding or spotting. If this continues beyond 2 months, contact your healthcare provider.

Your health care provider will monitor your child regularly to see how this medicine is working. Keep all appointments.

During the early stages of treatment with this medicine, there may be more symptoms of puberty. These symptoms should go away with time.

Contact your healthcare provider right away if there is any irritation at the spots where shots are given. Also report any unusual signs or symptoms.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (report these to your healthcare provider right away): Vaginal bleeding or spotting that continues beyond 2 months of treatment, irritation or rash at the spot where a shot has been given.

Other: General pain, acne, rash, body odor, fever, headache, stomach upset, feeling faint

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• medicines to treat diabetes such as acarbose (Precose), glipizide (Glucotrol), glyburide (DiaBeta, Micronase, Glynase), metformin (Glucophage), miglitol (Glyset), nateglinide (Starlix), repaglinide (Prandin), pioglitazone (Actos), and rosiglitazone (Avandia)

Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.

Keep all medicines out of the reach of children.

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