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|Leuprolide Suspension

Leuprolide Suspension

Leuprolide Suspension is used for:

Primarily managing endometriosis, including pain relief and decreasing the size of lesions. It is used with iron therapy to improve anemia before surgery in patients with fibroids of the uterus. Leuprolide Suspension may be used for treating 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 and preventing 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, planning to become pregnant, or 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.

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, plan 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 smoke, drink alcohol, or use tobacco regularly
• if you have osteoporosis (brittle bones) or a family history of osteoporosis
• if you have depression, mental disorders, memory problems, or high cholesterol (lipids)

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

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 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.
• Leuprolide Suspension comes with an additional patient leaflet. Read it carefully and reread it each time you get Leuprolide Suspension refilled.
• Keep this product, as well as syringes and needles, out of the reach of children. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for proper 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 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. A nonhormonal form of birth control (eg, condom, diaphragm) should be used during treatment with Leuprolide Suspension.
• A small decrease in bone density may occur during treatment with Leuprolide Suspension. Your risk of bone loss may be increased if you use Leuprolide Suspension for long periods of time (more than 6 months) or with other medicines that cause bone loss. If you are uncertain if your other medicines may increase risk of bone loss, contact your doctor or pharmacist.
• LAB TESTS are recommended before using Leuprolide Suspension. A pregnancy test should be negative before starting treatment. A bone density test is recommended before being treated a second time with 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. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Leuprolide Suspension may cause harm to an unborn baby, do not use Leuprolide Suspension if you are pregnant. If you suspect that you could be pregnant, contact your doctor immediately. It is unknown if Leuprolide Suspension is excreted 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:

Abnormal hair growth; abnormal skin sensations; acne; breast pain and tenderness; changes in breast size; changes in weight; decreased sex drive; depression; dizziness; headache; hot flashes/sweats; joint disorder; mood changes; muscle pain; nausea/vomiting; nervousness; pain; skin reactions; swelling; vaginal dryness; weakness.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); continued vaginal bleeding; delusions; depression; dizziness; joint pain; memory loss; suicidal thoughts; swelling of the ankles or hands; weight gain or loss.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or 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/findyour.htm), or emergency room immediately.

Store Leuprolide Suspension at room temperature 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.