Lupron Depot-Ped

Leuprolide is used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (e.g., growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down the rate of early bone growth so that the chances for reaching normal adult height are increased. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

It is very important that you do not miss any doses. However, if you do miss a dose, contact the doctor promptly to establish a new schedule.

This medication is given as an injection into a muscle (intramuscularly), usually once a month by a health care professional or as directed by the doctor. This product slowly releases the medication into your blood over a 1-month period. In children, the dosage is based on weight and response to therapy. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details. If you are directed to inject this medication yourself, learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If any of the information is unclear, consult the doctor or pharmacist. Change the location of the injection site each time to avoid problem areas under the skin. Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose. Inform the doctor if your condition persists or worsens. You should start to see an improvement in symptoms usually in 1-2 months.

The doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with the doctor or pharmacist first. Before using this medication, tell the doctor or pharmacist of all prescription and nonprescription/herbal products you may use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (USA) or 1-800-668-1507 (Canada).

Do not share this medication with others. Laboratory and/or medical tests (e.g., hormone levels, bone tests) should be performed periodically to monitor your progress. Consult the doctor for more details.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Before using leuprolide, tell the doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell the doctor or pharmacist your medical history, especially of: bone problems (thinning bones). This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. Leuprolide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. Non-hormonal birth control methods (e.g., condoms, diaphragm with spermicide) are recommended during treatment with leuprolide. It is not known if leuprolide passes into breast milk. Because the effects of leuprolide on a nursing infant are unknown, breast-feeding is not recommended. Consult your doctor before breast-feeding.

Store at room temperature at 77 degrees F (25 degrees C) away from moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Once mixed, use the medication immediately. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Mild burning/pain/bruising at the injection site, hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, vaginal bleeding, swelling of the ankles/feet, or dizziness may occur. If any of these effects persist or worsen, tell the doctor or pharmacist promptly. When this medication is used regularly, it is expected that the menstrual period will stop (or decrease to light bleeding/spotting during the first 2 months). Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide. During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to this drug. This may result in a temporary increase in your symptoms for a few weeks. Remember that the doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell the doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression, thoughts of suicide, mood swings, aggression in children), bone pain (in adults). Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Seek immediate medical attention if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact the doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. Other leuprolide products may also be used to treat prostate cancer in men and disorders of the uterus (e.g., endometriosis, fibroids) in women.