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Lupron Depot 11.25 mg depot suspension

Generic Name: leuprolide (LOO-proe-lide)
Brand Name: Lupron Depot 11.25 mg

Lupron Depot 11.25 mg depot suspension is used for:

Treating endometriosis. It may be used alone or with other medicines (eg, norethindrone). It is used with iron therapy to improve anemia before surgery in patients with fibroids of the uterus. It may also be used for other conditions as determined by your doctor.

Lupron Depot 11.25 mg depot suspension is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones and preventing the growth of certain tumors that need these hormones to grow.

Do NOT use Lupron Depot 11.25 mg depot suspension if:

  • you are allergic to any ingredient in Lupron Depot 11.25 mg depot suspension, to GnRH, or to another GnRH analog (eg, histrelin)
  • you are pregnant, able to become pregnant, or are breast-feeding
  • you have unusual vaginal bleeding of an unknown cause

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

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Before using Lupron Depot 11.25 mg depot suspension:

Some medical conditions may interact with Lupron Depot 11.25 mg depot 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 drink alcohol, smoke, or use tobacco regularly
  • if you have a history of mood or mental problems (eg, depression, mental disorders, memory problems)
  • if you have bone problems (eg, osteoporosis, brittle bones) or a family history of bone problems
  • 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, heart problems, blood vessel problems (eg, in the brain), or a stroke
  • if you take corticosteroids (eg, prednisone), anticonvulsants (eg, carbamazepine), or other medicines that may reduce bone strength
  • 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 Lupron Depot 11.25 mg depot suspension. However, no specific interactions with Lupron Depot 11.25 mg depot suspension are known at this time.

Ask your health care provider if Lupron Depot 11.25 mg depot 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 Lupron Depot 11.25 mg depot suspension:

Use Lupron Depot 11.25 mg depot suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Lupron Depot 11.25 mg depot suspension is usually administered every 3 months (12 weeks) as an injection at your doctor's office, hospital, or clinic. It must be administered under the supervision of a doctor.
  • 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.
  • The suspension settles very quickly following reconstitution; therefore, it should be used immediately after mixing.
  • If you miss a dose of Lupron Depot 11.25 mg depot suspension, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Lupron Depot 11.25 mg depot suspension.

Important safety information:

  • Lupron Depot 11.25 mg depot suspension may cause dizziness. This effect may be worse if you use it with alcohol or certain medicines. Use Lupron Depot 11.25 mg depot suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Lupron Depot 11.25 mg depot suspension may cause birth defects, or fetal or newborn death if you take it while you are pregnant. You should have a negative pregnancy test before you start Lupron Depot 11.25 mg depot suspension. Talk with your doctor for more information.
  • Lupron Depot 11.25 mg depot suspension usually stops menstruation (periods). Missing doses of Lupron Depot 11.25 mg depot suspension may cause breakthrough bleeding. Notify your doctor if regular menstruation continues.
  • Ovulation usually stops while using Lupron Depot 11.25 mg depot suspension; however, this is not a reliable form of birth control because breakthrough ovulation may occur during treatment. Birth control pills may also not be effective. To prevent pregnancy, use a nonhormonal form of birth control (eg, condom, diaphragm) during treatment with Lupron Depot 11.25 mg depot suspension.
  • Certain hormone levels may increase during the first few weeks of treatment with Lupron Depot 11.25 mg depot suspension. 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 11.25 mg depot suspension.
  • Lupron Depot 11.25 mg depot 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.
  • 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.
  • Lupron Depot 11.25 mg depot 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 serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of Lupron Depot 11.25 mg depot 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 - Lupron Depot 11.25 mg depot suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including hemoglobin A1c, blood glucose, and bone density, may be performed while you use Lupron Depot 11.25 mg depot suspension. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Lupron Depot 11.25 mg depot 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 Lupron Depot 11.25 mg depot suspension.
  • Lupron Depot 11.25 mg depot suspension should not be used in ELDERLY patients older than 65 years old.
  • Lupron Depot 11.25 mg depot suspension should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Lupron Depot 11.25 mg depot 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 Lupron Depot 11.25 mg depot suspension is found in breast milk. Do not breast-feed while using Lupron Depot 11.25 mg depot suspension.

Possible side effects of Lupron Depot 11.25 mg depot 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:

Acne; changes in weight; dizziness; general body pain; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); nausea or vomiting; 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, or tingling; decreased hearing; fainting; memory problems; new or worsening bone pain; new or worsening mood or mental changes (eg, anxiety, delusions, depression, memory problems, nervousness); 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); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual vaginal itching, irritation, discharge, or odor; 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 Lupron Depot 11.25 mg depot suspension:

Store Lupron Depot 11.25 mg depot 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. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Lupron Depot 11.25 mg depot suspension out of the reach of children and away from pets.

General information:

  • If you have any questions about Lupron Depot 11.25 mg depot suspension, please talk with your doctor, pharmacist, or other health care provider.
  • Lupron Depot 11.25 mg depot 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 Lupron Depot 11.25 mg depot 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 Lupron Depot 11.25 mg depot suspension. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Lupron Depot 11.25 mg depot 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 Lupron Depot 11.25 mg depot suspension.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
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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