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Leuprolide suspension

Pronunciation

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

Leuprolide suspension is used for:

Treating symptoms of advanced prostate cancer. It may also be used for certain conditions as determined by your doctor.

Leuprolide suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This prevents the growth of certain tumors that need these hormones to grow.

Do NOT use leuprolide suspension if:

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

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

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Before using leuprolide suspension:

Some medical conditions may interact with leuprolide suspension. 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 a history of diabetes or high blood sugar, urinary problems (eg, a blockage of the bladder or ureters), spinal cord problems, abnormal growths on or near the spinal cord, nervous system problems (eg, tumors), seizures, a certain type of irregular heartbeat (congenital long QT syndrome) or other heart problems (eg, congestive heart failure), blood vessel problems (eg, in the brain), or a stroke
  • if you have bone problems (eg, weak bones, osteoporosis), or if a family member has had bone problems
  • if you have blood electrolyte problems (eg, low blood magnesium or potassium levels)
  • if you are taking medicines that can weaken the bones, such as anticonvulsants (eg, phenytoin) or corticosteroids (eg, prednisone)
  • if you take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) or seizures. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of these problems

Some MEDICINES MAY INTERACT with leuprolide suspension. Tell your health care provider if you are taking any other medicines, especially any of the following: Antiarrhythmic medicines (eg, amiodarone, quinidine, sotalol) because they may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) Bupropion or selective serotonin reuptake inhibitors (SSRIs) (eg, sertraline) because they may increase the risk of seizures

This may not be a complete list of all interactions that may occur. Ask your health care provider if leuprolide suspension 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 suspension:

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

  • Leuprolide suspension 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 suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use leuprolide suspension. 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 suspension if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • 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.
  • Do not miss any doses of leuprolide suspension. If you miss a dose of leuprolide suspension, contact your doctor right away.

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

Important safety information:

  • Certain hormone levels may increase during the first few weeks of treatment with leuprolide suspension. This may cause you to experience worsening symptoms or onset of new symptoms (eg, bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or a blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using leuprolide suspension.
  • Leuprolide suspension lowers the amount of certain hormones in your body. This may result in certain effects, such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Discuss any questions or concerns with your doctor.
  • Leuprolide suspension may cause your bones to weaken (decreased bone density) or become more prone to fractures, especially if you use it for a long time. Contact your doctor if you notice bone pain or if you have questions or concerns.
  • A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor.
  • A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of leuprolide suspension. 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.
  • High blood sugar and an increased risk of the development of diabetes has been reported in men who use GnRH agonists. Patients who already have diabetes may develop trouble controlling their blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients - Leuprolide suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Leuprolide suspension may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using leuprolide suspension.
  • Lab tests, including blood testosterone levels, prostate-specific antigen (PSA), hemoglobin A1c, blood glucose, and bone density, may be performed while you use leuprolide suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Leuprolide suspension should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use leuprolide suspension if you are pregnant. It may cause birth defects, or fetal or newborn death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if leuprolide suspension is found in breast milk. Do not breast-feed while using leuprolide suspension.

Possible side effects of leuprolide suspension:

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:

Dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); tiredness; trouble sleeping; weakness.

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); black, tarry stools; blood in the urine; burning, numbness, tingling, or weakness; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, nervousness); new or worsening bone pain; paralysis; seizures; severe dizziness or light-headedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; swelling of the hands, ankles, or feet; symptoms of heart attack (eg, chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes); symptoms of high blood sugar (eg, drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination); symptoms of infection (eg, chills, fever); symptoms of stroke (eg, confusion, one-sided weakness, slurred speech, vision changes); unusual bruising or bleeding; urination problems (eg, trouble urinating, inability to urinate, painful urination); vision changes or blurred vision; vomit that looks like coffee grounds.

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 suspension:

Store leuprolide suspension at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Because the product does not contain a preservative, once mixed, discard the suspension if not used right away. Store away from heat, moisture, and light. Do not store in the bathroom. Keep leuprolide suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about leuprolide suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Leuprolide suspension 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 suspension 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 suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to leuprolide suspension. 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 suspension.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
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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