leuprolide

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

Your symptoms may become temporarily worse when you first start using leuprolide. Tell your doctor if this continues for longer than 2 months.

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 at least 2 years old.

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

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

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

Tell your doctor if you have ever had:

• depression, mental illness or psychosis;
• seizures or epilepsy;
• a blood vessel disorder;
• a brain tumor or spinal cord injury;
• heart disease, congestive heart failure, long QT syndrome;
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood); or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Do not give this medicine to any child without medical advice.

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy. Leuprolide can make hormonal birth control less effective (birth control pills, injections, implants, skin patches, vaginal rings).

How should I use leuprolide?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Leuprolide is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider can teach you how to properly use the medication by yourself.

Read and carefully follow any Instructions for Use provided with your medicine. Do not use leuprolide if you don't understand all instructions for proper use. Ask your doctor or pharmacist if you have questions.

Your symptoms may become temporarily worse as your hormones adjust to leuprolide. A child using this medicine may have increased signs of puberty (such as vaginal bleeding) during the first weeks of treatment.

Keep using the medicine as directed, and tell your doctor if your condition is still worse after 2 months of using this medicine.

You may need frequent medical tests while using leuprolide. Bone growth may need to be checked in a child treated with Fensolvi.

Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it 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?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of leuprolide?

• problems with your pituitary gland --sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• bone pain, loss of movement in any part of your body;
• swelling, rapid weight gain;
• a seizure;
• unusual changes in mood or behavior (crying spells, anger, feeling irritable);
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination; or
• high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

• 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;
• 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.

Common side effects may include:

• pituitary gland problems;
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, constipation;
• wheezing, chest tightness, trouble breathing;
• hot flashes, sweating;
• dizziness, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• decreased interest in sex; or
• redness, 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?

Other drugs may affect leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about leuprolide.