Lupron Depot-PED

Lupron Depot-PED is used for:

Treating children with premature development of secondary sexual characteristics (precocious puberty), such as breast development before the age of 8 in girls or genital development 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 (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This reverses the premature development of secondary sexual characteristics, prevents premature bone aging, and allows for normal physical and psychological growth and development.

Do NOT use Lupron Depot-PED if:

• you are allergic to any ingredient in Lupron Depot-PED, to GnRH, or to another GnRH agonist (eg, histrelin)
• you are pregnant, able to become pregnant, may become pregnant, or are breast-feeding

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 pregnant, planning to become pregnant, or 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 urinary problems (eg, a blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord

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

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.

• An extra patient leaflet is available with Lupron Depot-PED. Talk to your pharmacist if you have questions about this information.
• Lupron Depot-PED is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Lupron Depot-PED at home, a health care provider will teach you how to use it. Be sure you understand how to use Lupron Depot-PED. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Do not use Lupron Depot-PED if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use Lupron Depot-PED on a regular schedule to get the most benefit from it.
• Continue to use Lupron Depot-PED even if you feel well. Do not miss any doses.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
• If the child misses a dose of Lupron Depot-PED, contact the child's doctor.

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

Important safety information:

• Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot-PED. You may notice an increase in symptoms or onset of new symptoms during this time. Tell your doctor if any new symptoms occur, or if you have worsened symptoms that last longer than a few weeks after you start to use Lupron Depot-PED.
• 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.
• A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot-PED. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
• It is important to use Lupron Depot-PED exactly as directed by your doctor. You must follow the prescribed treatment schedule for the medicine to be successful.
• Lupron Depot-PED may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctors and lab personnel know you are using Lupron Depot-PED.
• Lab tests, including hormone levels (eg, testosterone or estrogen, gonadotropin) and bone growth checks, may be performed while you use Lupron Depot-PED. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• PREGNANCY and BREAST-FEEDING: Lupron Depot-PED may cause birth defects or fetal or newborn death if you use it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Lupron Depot-PED is found in breast milk. Do not breast-feed while using 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; mild headache; oily skin.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); fainting; injection-site irritation (eg, burning, itching, pain, stinging, swelling); mood or mental changes (eg, anxiety, depression, nervousness); numbness or tingling of the arms or legs; seizures; severe drowsiness; severe or persistent dizziness, lightheadedness, or headache; shortness of breath; signs of infection (eg, fever, chills, sore throat); slow, fast, or irregular heartbeat; trouble urinating (eg, loss of bladder control); unusual swelling of the hands, ankles, or feet; unusual weight gain; vaginal itching, irritation, odor, bleeding, or discharge; vision changes or blurred vision.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Lupron Depot-PED side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

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. Store away from heat, moisture, and light. Do not store in the bathroom. 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.
• Check with your pharmacist about how to dispose of unused medicine.

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.