Leuprolide

Generic name: Leuprolide

Usage of Leuprolide

Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer.

Leuprolide injection (Lupron Depot-PED, Fensolvi) is used in children 2 years of age or older to treat central precocious puberty (CPP; a condition causing girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics).

Leuprolide injection (Lupron Depot) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms).

Leuprolide injection (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus).

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.

Leuprolide side effects

Get emergency medical help if you have signs of an allergic reaction to leuprolide (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have a seizure, unusual changes in mood or behavior (crying spells, irritability, restlessness, anger, aggression), severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

Leuprolide may cause serious side effects. Call your doctor at once if you have:

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;

pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;

muscle weakness or loss of muscle use, loss of bladder or bowel control;

problems with your pituitary gland - sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;

high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor;

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, severe headache, slurred speech, problems with vision or balance.

Common leuprolide side effects may include:

pituitary gland problems;

acne, itching, rash, white scales (seborrhea);

cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;

fractures, ligament sprain;

fever, tiredness, not feeling well;

stomach pain, nausea, vomiting, diarrhea, constipation;

wheezing, chest tightness, trouble breathing;

breast tenderness, hot flashes, sweating;

dizziness, sleep problems, mood changes;

headache, general pain;

vaginal swelling, itching, or discharge;

weight changes;

decreased testicle size;

irregular menstrual periods, decreased interest in sex; or

redness, pain, swelling, or oozing where the medicine was injected.

Leuprolide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using leuprolide.

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.

Before taking Leuprolide

You should not use this medicine if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.

To make sure leuprolide is safe for you, 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).

Leuprolide usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Use barrier birth control to prevent pregnancy: condom, diaphragm, cervical cap, or contraceptive sponge.

Call your doctor if your periods continue while you are being treated with leuprolide.

Leuprolide may cause birth defects. Do not use leuprolide if you are pregnant. Tell your doctor if you become pregnant.

Ask a doctor if it is safe to breastfeed while using this medicine.

How to use Leuprolide

Usual Adult Dose for Endometriosis:

3.75 mg IM once a month for up to 6 months OR 11.25 mg depot every 3 months Comments: -In women receiving this drug for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms. Uses: Management of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata

Usual Adult Dose for Prostate Cancer:

Eligard: administered by suBCutaneous injection and provides continuous release of leuprolide acetate over a one, three, four, or six-month period:

One 7.5 mg injection every month; or

One 22.5 mg injection every 3 months; or

One 30 mg injection every 4 months; or

One 45 mg injection every 6 months,

Viadur: one implant inserted for 12 months. Each implant contains 65 mg leuprolide. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of leuprolide for 12 months of hormonal therapy.

Usual Pediatric Dose for Precocious Puberty:

IM Injection: 2 years and older: One month depot injection: 25 kg or less: 7.5 mg IM once a month. Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month. Greater than 37.5 kg: 15 mg IM once a month Three month depot injection: 11.25 mg or 30 mg IM every 3 months Comments: -Doses should be titrated to the individual. -Hormone levels should be tested after 1 to 2 months of therapy and with each dose change to ensure adequate pituitary gonadotropin suppression. -Once a dose that results in adequate hormonal suppression has been determined, it can often be maintained for the duration of therapy in most children; however, hormonal suppression should be verified as weight can increase significantly while on therapy. -Therapy should be discontinued at the appropriate age of onset of puberty at the discretion of the physician. Subcutaneous injection: 2 years and older: Fensolvi (long acting formulation): 45 mg subcutaneously every 6 months NOTE: The short-acting formulation has been replaced with long-acting formulations. Comments: -The dosage should be adjusted for weight changes. -Discontinuation of therapy be considered before age 11 for females and before age 12 for males. Use: Treatment of children with central precocious puberty (CPP); CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years in girls and 9 years in boys) associated with pubertal pituitary gonadotropin activation; it may show a significantly advanced bone age that can result in diminished adult height

Warnings

Call your doctor at once if you have a seizure, unusual changes in mood or behavior, severe headaches, ringing in your ears, dizziness, nausea, vision problems, or pain behind your eyes.

Do not use leuprolide if you are pregnant. Use effective birth control. Do not use if you have abnormal vaginal bleeding that has not been checked by a doctor.

What other drugs will affect Leuprolide

Leuprolide can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

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