Leuprolide Suspension

Generic Name: Leuprolide (LOO-proe-lide)Brand Name: Lupron Depot 3.75 mg

Leuprolide 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.

Leuprolide Suspension is a gonadotropin-releasing hormone 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
  • you are pregnant, able to become pregnant, or are breast-feeding
  • you have unusual vaginal bleeding of an unknown cause
  • you have a history of blood clots or clotting problems, vein inflammation caused by a blood clot, a stroke or other bleeding in the brain, or moderate to severe liver or kidney problems

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

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 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), or high cholesterol (lipids)
  • if you have bone problems (eg, osteoporosis, brittle bones) or a family history of bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spinal cord
  • if you take corticosteroids (eg, prednisone), anticonvulsants (eg, carbamazepine), or other medicines that may reduce bone strength

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

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 administered once a month as an injection at your doctor's office, hospital, or clinic. It must be administered under the supervision of a doctor.
  • An extra patient leaflet is available with Leuprolide Suspension. Talk to your pharmacist if you have questions about this information.
  • 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.
  • The suspension settles very quickly following reconstitution; therefore, it should be used immediately after mixing.
  • Do not miss any doses of Leuprolide Suspension. Missing doses will decrease the effectiveness of Leuprolide Suspension.

Ask your health care provider any questions you may have about how to use Leuprolide Suspension.

Important safety information:

  • Leuprolide Suspension may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Leuprolide Suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Leuprolide Suspension may cause birth defects or fetal or newborn death if you take it while you are pregnant. You should have a negative a pregnancy test before you start Leuprolide Suspension. Talk with your doctor for more information.
  • Leuprolide Suspension usually stops menstruation (periods). Missing doses of Leuprolide Suspension may cause breakthrough bleeding. Notify your doctor if regular menstruation continues.
  • Ovulation usually stops while using Leuprolide Suspension, but 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, a nonhormonal form of birth control (eg, condom, diaphragm) should be used during treatment with Leuprolide Suspension.
  • Certain hormone levels may increase during the first few weeks of treatment with Leuprolide 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 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), 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 Leuprolide Suspension. Most cases developed within 2 weeks after the first dose. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, mental or mood changes, eye weakness, inability to move your eyes, or vision changes.
  • Lab tests, including liver function and bone density tests, 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 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 Suspension.
  • Leuprolide Suspension should not be used in ELDERLY patients older than 65 years of age.
  • Leuprolide Suspension is not recommended for use in CHILDREN younger than 18 years of age; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Leuprolide Suspension may cause birth defects/fetal and 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:

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 urine; chest pain; confusion; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, memory problems, nervousness); numbness or tingling of the arms or legs; seizures; severe dizziness or lightheadedness; severe drowsiness; severe headache; shortness of breath; slow, fast, or irregular heartbeat; symptoms of infection (eg, chills, fever); trouble urinating (eg, loss of bladder control, unable to urinate, painful urination); unusual or one-sided weakness; 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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

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

Proper storage of Leuprolide Suspension:

Store Leuprolide Suspension between 68 and 77 degrees F (20 and 25 degrees C). Brief excursions at temperatures between 59 and 86 degrees F (15 and 30 degrees C) are permitted. 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.

This information is a summary only. It does not contain all information about Leuprolide Suspension. 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.

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