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Brand Names: Eligard, Lupron, Lupron Depot, Lupron Depot-Gyn, Lupron Depot-Ped

Generic Name: leuprolide (Pronunciation: LOO proe lide)

• What is leuprolide (Eligard)?
• What are the possible side effects of leuprolide (Eligard)?
• What is the most important information I should know about leuprolide (Eligard)?
• What should I discuss with my healthcare provider before using leuprolide (Eligard)?
• How should I use leuprolide (Eligard)?
• What happens if I miss a dose (Eligard)?
• What happens if I overdose (Eligard)?
• What should I avoid while using leuprolide (Eligard)?
• What other drugs will affect leuprolide (Eligard)?
• Where can I get more information?

What is leuprolide (Eligard)?

Leuprolide is a man-made form of a hormone that regulates many processes in the body. Leuprolide overstimulates the body's own production of certain hormones, which causes that production to shut down temporarily. Leuprolide reduces the amount of testosterone in men or estrogen in women.

Leuprolide is used in men to treat the symptoms of prostate cancer. Leuprolide treats only the symptoms of prostate cancer and does not treat the cancer itself. Use any other medications your doctor has prescribed to best treat your condition.

Leuprolide is used in women to treat symptoms of endometriosis (overgrowth of uterine lining outside of the uterus) or uterine fibroids.

Leuprolide is also used to treat precocious (early-onset) puberty in both male and female children.

Leuprolide may also be used for other purposes not listed in this medication guide.

What are the possible side effects of leuprolide (Eligard)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• bone pain;
• swelling, rapid weight gain;
• pain, burning, stinging, bruising, or redness where the medication was injected;
• feeling like you might pass out;
• painful or difficult urination;
• urinating more often than usual; or
• sudden headache with vision problems, vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing.

Rare but serious side effects may include:

• pain or unusual sensations in your back;
• numbness, weakness, or tingly feeling in your legs or feet;
• muscle weakness or loss of use; and
• loss of bowel or bladder control.

Less serious side effects may include:

• acne, increased growth of facial hair;
• breakthrough bleeding in a female child during the first 2 months of leuprolide treatment;
• dizziness, weakness, tired feeling;
• hot flashes, night sweats, chills, clammy skin;
• nausea, diarrhea, constipation, stomach pain;
• skin redness, itching, or scaling;
• joint or muscle pain;
• vaginal itching or discharge
• breast swelling or tenderness;
• testicle pain;
• impotence, loss of interest in sex;
• depression, sleep problems (insomnia), memory problems; or
• redness, burning, itching, or swelling where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about leuprolide (Eligard)?

This medication can cause birth defects. Do not use if you are pregnant. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not use this medication if you are allergic to leuprolide or similar medications such as buserelin (Suprefact, Suprecor), goserelin (Zoladex), histrelin (Supprelin), nafarelin (Synarel), or if you have abnormal vaginal bleeding that has not been diagnosed by a doctor; or if you are breast-feeding a baby.

Before using leuprolide, tell your doctor if you have epilepsy, asthma, migraines, heart or kidney disease, a history of depression, bone cancer affecting your spine, blood in your urine, or if you are unable to urinate.

Tell your doctor if you have a personal or family history of osteoporosis, or if you have any risk factors for bone loss such as smoking, alcohol use, or taking steroid or seizure medications long term. Long-term use of this medication may decrease bone density, possibly leading to osteoporosis.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medication to make sure you have received the correct brand and strength prescribed by your doctor.