Leuprolide Injection Kit

Leuprolide Injection Kit is used for:

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

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

Do NOT use Leuprolide Injection Kit if:

• you are allergic to any ingredient in Leuprolide Injection Kit, GnRH, or 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.

Before using Leuprolide Injection Kit:

Some medical conditions may interact with Leuprolide Injection 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 bone problems, urinary problems (eg, blockage of the bladder or ureters), spinal cord problems, or abnormal growths on or near the spine or spinal cord

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

Ask your health care provider if Leuprolide Injection 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 Injection Kit:

Use Leuprolide Injection Kit as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Leuprolide Injection Kit is usually given every month (4 weeks) as an injection at your doctor's office, hospital, or clinic. If you will be using Leuprolide Injection Kit at home, a health care provider will teach you how to use it. Be sure you understand how to use Leuprolide Injection 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 Injection Kit if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle.
• 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.
• If you miss a dose of Leuprolide Injection Kit, contact your doctor right away.

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

Important safety information:

• Certain hormone levels may increase during the first few weeks of treatment with Leuprolide Injection Kit. 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 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 Injection Kit.
• Leuprolide Injection Kit lowers the amount of certain hormones in your body. This may cause certain expected side effects to occur, such as breast enlargement, soreness, or tenderness; testicular changes, pain, or soreness; decreased sexual ability; hot flashes; or night sweats. Contact your doctor if you have questions or concerns or if you experience any of these side effects.
• Leuprolide Injection Kit may cause your bones to weaken or become more prone to fractures, especially if you use Leuprolide Injection Kit for long periods of time. Contact your doctor if you experience bone pain or if you have concerns regarding changes in bone density.
• Rarely, a serious pituitary gland problem (pituitary apoplexy) may occur after you use Leuprolide Injection Kit. This serious problem usually occurs shortly after you begin to use Leuprolide Injection Kit. Contact your doctor immediately if you experience a sudden headache, vomiting, fainting, eye weakness, inability to move your eyes, mental status changes, or vision changes.
• Lab tests, including blood testosterone levels, prostate-specific antigen (PSA) levels, and bone density, may be performed while you use Leuprolide Injection 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 Injection Kit may interfere with certain lab tests, including certain hormone tests and pituitary gland function tests. Be sure your doctor and lab personnel know you are using Leuprolide Injection Kit.
• Leuprolide Injection Kit should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Leuprolide Injection Kit is not approved for use in women. Leuprolide Injection Kit may cause birth defects or fetal 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 Injection Kit is found in breast milk. Do not breast-feed while using Leuprolide Injection Kit.

Possible side effects of Leuprolide Injection 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:

Dizziness; hot flashes; increased sweating; mild burning, bruising, itching, pain, redness, stinging, or swelling at the injection site; muscle pain; tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bone pain; burning, numbness, or tingling; fainting; mental or mood changes (eg, depression); seizures; severe dizziness or lightheadedness; sudden, severe headache; unusual tiredness or weakness; urination problems (eg, inability to urinate, loss of bladder control, painful urination); vision changes.

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.

See also: Leuprolide side effects (in more detail)

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.

Store Leuprolide Injection Kit in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Once mixed, Leuprolide Injection Kit must be used within 30 minutes. Discard Leuprolide Injection Kit if it is not used within 30 minutes. Keep Leuprolide Injection Kit out of the reach of children and away from pets.

General information:

• If you have any questions about Leuprolide Injection Kit, please talk with your doctor, pharmacist, or other health care provider.
• Leuprolide Injection 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 is a summary only. It does not contain all information about Leuprolide Injection Kit. 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.