DrugindexOnline^{2nd edition}

Generic Name: Leuprolide Pediatric Injection Kit (loo-PRO-lide)
Brand Name: Lupron Depot-PED

Lupron Depot-PED is used for:

Treating premature development of secondary sexual characteristics, such as breast development in girls or genital development in boys, that occur before the age of 8 in girls and before the age of 9 in boys. It may also be used for other conditions as determined by your doctor.

Lupron Depot-PED is a gonadotropin-releasing hormone agonist. It works by inhibiting gonadotropin secretion, which inhibits ovarian and testicular steroid production.

Do NOT use Lupron Depot-PED if:

• you are allergic to any ingredient in Lupron Depot-PED
• you are pregnant

Contact your doctor or health care provider right away if any of these apply to you.

Before using Lupron Depot-PED :

Some medical conditions may interact with Lupron Depot-PED . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a blockage of the urinary tract or cancer that has spread into the spine

Some MEDICINES MAY INTERACT with Lupron Depot-PED . However, no specific interactions with Lupron Depot-PED are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lupron Depot-PED may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Lupron Depot-PED :

Use Lupron Depot-PED as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Lupron Depot-PED is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Lupron Depot-PED at home, carefully follow the injection procedures taught to you by your health care provider.
• To prepare for injection, screw the white plunger into the end stopper until the stopper begins to turn. Hold the syringe upright. Release the diluent by slowly pushing (6 to 8 seconds) the plunger until the first stopper is at the blue line in the middle of the barrel. Keep the syringe upright. Gently mix the microspheres thoroughly to form a uniform suspension. The suspension will appear milky. Hold the syringe upright. With the opposite hand, pull the needle cap upward without twisting. Keep the syringe upright. Advance the plunger to expel the air from the syringe. Inject the entire contents of the syringe intramuscularly at the time of reconstitution. The suspension settles very quickly following reconstitution; therefore, leuprolide pediatric injection should be mixed and used immediately. Withdraw the needle. Immediately activate the safety device by pushing the arrow forward with the thumb or finger until the device is fully extended and a click is heard or felt.
• If Lupron Depot-PED contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
• Lupron Depot-PED is given every 4 weeks.
• Use Lupron Depot-PED regularly to receive the most benefit from it.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• If your child misses a dose of Lupron Depot-PED , contact your child's doctor.

Ask your health care provider any questions you may have about how to use Lupron Depot-PED .

Important safety information:

• Lupron Depot-PED may cause increased sensitivity to the sun. Avoid exposure to the sun, sunlamps, or tanning booths until you know how you react to Lupron Depot-PED . Use a sunscreen or protective clothing if you must be outside for a prolonged period.
• During the first 2 months of taking Lupron Depot-PED , vaginal bleeding or spotting may occur. If bleeding continues after the second month, contact your health care provider.
• LAB TESTS, such as sex steroid and hormone level measurements, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: Lupron Depot-PED may cause harm to the fetus. Avoid becoming pregnant while taking Lupron Depot-PED . If you think you may be pregnant, discuss with your doctor the benefits and risks of using Lupron Depot-PED during pregnancy. It is unknown if Lupron Depot-PED is excreted in breast milk. Do not breast-feed while taking Lupron Depot-PED .

Possible side effects of Lupron Depot-PED :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; breast enlargement; excessively oily skin; pain; vaginal bleeding or spotting; vaginal discharge; vaginal inflammation.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; increased sexual maturity; irritation at the injection site; mood or mental changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Lupron Depot-PED :

Store Lupron Depot-PED at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Lupron Depot-PED out of the reach of children and away from pets.

General information:

• If you have any questions about Lupron Depot-PED , please talk with your doctor, pharmacist, or other health care provider.
• Lupron Depot-PED is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Lupron Depot-PED . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.