Uses

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

This drug may also be used for prostate cancer.

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using leuprolide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a muscle by a health care professional. It is given as directed by your doctor, usually once every month. This product slowly releases the medication into your blood over a 1-month period.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Learn how to store and discard medical supplies safely.

Wash your hands and properly mix the medication. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Inject each dose within 2 hours of mixing. If more than 2 hours have passed since mixing, throw out the product and prepare another syringe/dose.

The length of treatment is based on your medical condition, response to treatment, and lab tests.

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.

During the first few weeks of treatment, your hormone levels will actually go up before they go down. This is a normal response to this medication. Your symptoms may get worse for a few weeks.

Tell your doctor if your condition does not get better or if it gets worse. It may take at least 3 months for your symptoms to get better.

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, swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

When this medication is used regularly, your menstrual period should stop (or bleeding should get lighter). Menstrual periods usually return within 3 months after treatment is stopped. Tell your doctor promptly if regular periods continue during treatment with leuprolide.

Remember that this medication has been prescribed because your doctor 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 (such as depression, thoughts of suicide, mood swings, aggression)
• new/worsening bone pain
• easily broken bones

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

• seizures

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 or at www.fda.gov/medwatch.

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 to similar drugs (such as histrelin, triptorelin); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• high blood fat levels (such as high cholesterol/triglycerides)
• mental/mood problems (such as depression)
• vaginal bleeding of unknown cause
• seizures

Leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time. 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 (for example, corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as hormone levels, bone tests, cholesterol/triglyceride blood levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to get each dose of this medication as scheduled. If a dose is missed, ask the doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Once mixed, use the medication right away. Keep all medications 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.