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Lupron Depot (3 Month) intramuscular

LEUPROLIDE 3 MONTH (11.25 MG) - INJECTION

GENERIC NAME(S): LEUPROLIDE ACETATE

Uses

Leuprolide is used to treat disorders of the uterus (e.g., endometriosis, fibroids) in women. It helps to reduce symptoms such as pelvic pain, painful/heavy menstrual periods, and abdominal bloating. It also shrinks the abnormal uterine tissue that causes these symptoms. For the treatment of fibroids, leuprolide is usually given with iron to help improve anemia that is caused by too much vaginal bleeding. Uterine tissue needs the female hormone estrogen to grow and spread. Leuprolide works by decreasing the amount of estrogen that is made in the female body.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

Other leuprolide products may also be used to treat prostate cancer in men.

Leuprolide may also be used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (e.g., growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down the rate of early bone growth so that the chances for reaching normal adult height are increased. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

How to use Lupron Depot (3 Month) intramuscular

This medication is given as an injection into a muscle (intramuscularly), usually once every 3 months by a health care professional or as directed by your doctor. This product slowly releases the medication into your blood over a 3-month period.

The length of treatment is based on your medical condition, response to therapy, and the condition of your bones since leuprolide may weaken bones. Consult your doctor for details. See also the Precautions section.

If you are directed to inject this medication yourself, learn all preparation and usage instructions in the product package. Learn how to store and discard needles and medical supplies safely. If any of the information is unclear, consult your doctor or pharmacist.

Change the location of the injection site each time to avoid problem areas under the skin.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.

Inform your doctor if your condition persists or worsens. In women, improvement in symptoms is usually seen in 3-6 months.

Side Effects

Hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, abnormal vaginal bleeding (in girls), swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

When this medication is used regularly, it is expected that the menstrual period will stop (or decrease to light bleeding/spotting). Menstrual periods usually return within 3 months after treatment is stopped. Tell your doctor promptly if regular periods continue during treatment with leuprolide.

During the first few weeks of treatment, your hormone levels will actually increase before they decrease. This is a normal response by your body to this drug. This may result in a temporary worsening of your symptoms for a few weeks.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (e.g., new or worsening depression, thoughts of suicide, mood swings, memory problems, aggression in children), bone pain (in adults), easily broken bones (in adults).

Get medical help right away if you have any very serious side effects, including: seizures.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after your first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (e.g., severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: vaginal bleeding of unknown cause.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fat levels (e.g., high cholesterol, high triglycerides), depression.

In adults, leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time because it reduces estrogen levels. Therefore, your doctor will carefully consider the length of treatment and monitor the health of your bones closely. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use of certain medications (e.g., corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Leuprolide must not be used during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately. Consult your doctor for more details and to discuss reliable forms of birth control. Non-hormonal birth control methods (e.g., condoms, diaphragm with spermicide) are recommended during treatment with leuprolide. See also the Missed Dose section.

It is not known if leuprolide passes into breast milk. Because the effects of leuprolide on a nursing infant are unknown, breast-feeding is not recommended. Consult your doctor before breast-feeding.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (e.g., hormone levels, bone tests, cholesterol/triglyceride blood levels) should be performed periodically to monitor your progress and check for side effects. Consult your doctor for more details.

Missed Dose

It is very important that you do not miss any doses. However, if you do miss a dose, contact your doctor promptly to establish a new schedule. If you miss a dose, breakthrough bleeding or ovulation may occur and you could get pregnant. Use reliable forms of non-hormonal birth control. See also Precautions.

Storage

Store at room temperature at 77 degrees F (25 degrees C) away from moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Once mixed, use the medication immediately. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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