Leuprolide Depot SuspensionGeneric Name:
Leuprolide (loo-PRO-lide)Brand Name:
Leuprolide Depot Suspension is used for:
Treating symptoms of advanced prostate cancer. It may also be used for other conditions as determined by your doctor.
Leuprolide Depot Suspension is a gonadotropin-releasing hormone agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. It prevents the growth of certain tumors that need these hormones to grow.
Do NOT use Leuprolide Depot Suspension if:
- you are allergic to any ingredient in Leuprolide Depot Suspension
- 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.
Before using Leuprolide Depot Suspension:
Some medical conditions may interact with Leuprolide 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 or other substances
- if you have 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 have vaginal bleeding
Some MEDICINES MAY INTERACT with Leuprolide Depot Suspension. However, no specific interactions with Leuprolide Depot Suspension are known at this time.
Ask your health care provider if Leuprolide 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 Leuprolide Depot Suspension:
Use Leuprolide Depot Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Leuprolide Depot Suspension. Talk to your pharmacist if you have questions about this information.
- Leuprolide Depot Suspension is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Leuprolide Depot Suspension at home, a health care provider will teach you how to use it. Be sure you understand how to use Leuprolide Depot Suspension. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- 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.
- Do not miss any doses of Leuprolide Depot Suspension. If you miss a dose of Leuprolide Depot Suspension, contact your doctor immediately.
Ask your health care provider any questions you may have about how to use Leuprolide Depot Suspension.
Important safety information:
- Certain hormone levels may increase during the first few weeks of treatment with Leuprolide 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 your start to use Leuprolide Depot Suspension.
- Leuprolide Depot Suspension lowers the amount of certain hormones in the 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 Depot 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 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.
- Leuprolide Depot 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 Depot Suspension.
- Lab tests, including blood testosterone levels, , prostate-specific antigen (PSA), and bone density tests, may be performed while you use Leuprolide 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.
- Leuprolide Depot Suspension is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Leuprolide Depot Suspension is not approved for use in women. Leuprolide Depot 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 Depot Suspension is found in breast milk. Do not breast-feed while using Leuprolide Depot Suspension.
Possible side effects of Leuprolide 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:
Dizziness; general body pain; headache; hot flashes; increased sweating; injection-site irritation (eg, mild burning, itching, pain, stinging, swelling); mild joint pain; muscle pain; tiredness; trouble sleeping; weakness.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; blood in urine; chest pain; decreased hearing; fainting; mood or mental changes (eg, anxiety, delusions, depression, 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 bruising or bleeding; 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 Depot Suspension:
Store Leuprolide 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. Because the product does not contain a preservative, once mixed, the suspension should be discarded if not used immediately. Keep Leuprolide Depot Suspension out of the reach of children and away from pets.
- If you have any questions about Leuprolide Depot Suspension, please talk with your doctor, pharmacist, or other health care provider.
- Leuprolide 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.
This information is a summary only. It does not contain all information about Leuprolide Depot 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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