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Leuprolide kit

Pronunciation

Generic Name: leuprolide (LOO-proe-lide)
Brand Name: Lupron Depot-PED

Leuprolide kit is used for:

Treating children with premature development of secondary sexual characteristics (precocious puberty), such as breast development before the age of 8 years old in girls or genital development before the age of 9 years old in boys. It may also be used for other conditions as determined by your doctor.

Leuprolide kit 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 leuprolide kit if:

  • you are allergic to any ingredient in leuprolide kit, to GnRH, or to another GnRH agonist (eg, histrelin)
  • you are pregnant, may become pregnant, or are breast-feeding

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

Slideshow: 2014 Update: First Time Brand-to-Generic Switches

Before using leuprolide kit:

Some medical conditions may interact with leuprolide kit. 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
  • if you have a history of seizures, nervous system problems (eg, tumors), or brain blood vessel problems
  • if you take bupropion, a selective serotonin reuptake inhibitor (SSRI) (eg, sertraline), or any other medicine that may increase the risk of seizures. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of seizures

Some MEDICINES MAY INTERACT with leuprolide kit. However, no specific interactions with leuprolide kit are known at this time.

Ask your health care provider if leuprolide kit 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 leuprolide kit:

Use leuprolide kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Leuprolide kit is usually given every 3 months (12 weeks) as an injection at your doctor's office, hospital, or clinic. If you will be using leuprolide kit at home, a health care provider will teach you how to use it. Be sure you understand how to use leuprolide kit. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Do not use leuprolide kit if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Do NOT use partial syringes or a combination of syringes to make up your dose.
  • Use leuprolide kit on a regular schedule to get the most benefit from it.
  • Continue to use leuprolide kit 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 away from 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 leuprolide kit, contact the child's doctor.

Ask your health care provider any questions you may have about how to use leuprolide kit.

Important safety information:

  • Certain hormone levels may increase during the first few weeks of treatment with leuprolide kit. 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 leuprolide kit.
  • During the first few weeks of taking leuprolide kit, 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 leuprolide kit. 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 leuprolide kit exactly as directed by your doctor. You must follow the prescribed treatment schedule for the medicine to be successful.
  • Leuprolide kit 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 leuprolide kit.
  • Lab tests, including hormone levels (eg, testosterone or estrogen, gonadotropin), height and weight measurements, and bone growth checks, may be performed while you use leuprolide kit. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Leuprolide kit should not be used in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use leuprolide kit if you are pregnant. It 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 leuprolide kit is found in breast milk. Do not breast-feed while using leuprolide kit.

Possible side effects of leuprolide kit:

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; hot flushes; mild headache; mild pain at the injection site; oily skin; sweating.

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

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, oozing, 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, light-headedness, 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.

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.

Proper storage of leuprolide kit:

Store leuprolide kit 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 leuprolide kit out of the reach of children and away from pets.

General information:

  • If you have any questions about leuprolide kit, please talk with your doctor, pharmacist, or other health care provider.
  • Leuprolide kit 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 should not be used to decide whether or not to take leuprolide kit or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about leuprolide kit. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to leuprolide kit. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using leuprolide kit.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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