leuprolide

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

What is leuprolide?

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 (but does not treat the cancer itself). 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 purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using leuprolide?

To make sure leuprolide is safe for you, tell your doctor if you have:

• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term);
• diabetes, high blood pressure, recent weight gain, high cholesterol (especially in men);
• heart disease, congestive heart failure, a history of long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);
• epilepsy;
• asthma;
• migraines;
• kidney disease;
• a history of depression;
• bone cancer affecting your spine;
• blood in your urine; or
• if you are unable to urinate.

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use a barrier form of birth control (condom or diaphragm with spermicide). Hormonal contraception (birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment.

How should I use leuprolide?

Leuprolide is injected under the skin or into a muscle, once every month or once every 3 to 6 months. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Your symptoms may become temporarily worse as your hormones adjust when you first start using this medication. Keep using the medication as directed, and your condition should eventually improve.

While using leuprolide, you may need frequent blood tests. Leuprolide can have long lasting effects on your body and you may also need medical tests for a short time after you stop using this medicine.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using leuprolide?

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

What are the possible side effects of leuprolide?

• bone pain, loss of movement in any part of your body;
• swelling, rapid weight gain;
• pain, burning, stinging, bruising, or redness where the medication was injected;
• vomiting, confusion, slow heart rate, weak pulse, fainting, or slow breathing;
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination;
• increased thirst or urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin;
• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke --sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

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, loss of bowel or bladder control; or
• liver problems --nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

• stomach discomfort;
• hot flashes, sweating, acne, rash, itching;
• headache, joint pain, or general pain;
• cold or flu symptoms, weakness, feeling tired, trouble breathing;
• breakthrough bleeding in a female child during the first weeks of leuprolide treatment;
• swelling, bloating, weight gain, problems with urination;
• vaginal itching or discharge;
• decreased testicle size; or
• redness, burning, stinging, pain, swelling, or oozing 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 other drugs will affect leuprolide?

Leuprolide can cause a serious heart problem, especially if you use certain medicines at the same time, including antibiotics, antidepressants, heart rhythm medicine, antipsychotic medicines, and medicines to treat cancer, malaria, HIV or AIDS. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with leuprolide.

Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about leuprolide.