In the U.S.—

In Canada—

Another commonly used name is leuprorelin.

• Antiendometriotic agent
• Antineoplastic
• Gonadotropin-releasing hormone analog
• Gonadotropin inhibitor

Leuprolide (loo-PROE-lide) may be used for a number of different medical problems. These include treatment of:

• anemia caused by bleeding of uterine leiomyomas (tumors in the uterus);
• cancer of the prostate gland in men;
• central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age);
• pain due to endometriosis in women.

Leuprolide is similar to a hormone normally released from the hypothalamus gland.

When given regularly to men and boys, leuprolide decreases testosterone levels. Reducing the amount of testosterone in the body is one way of treating cancer of the prostate.

When given regularly to women and girls, leuprolide decreases estrogen levels. Reducing the amount of estrogen in the body is one way of treating endometriosis. By shrinking tumors in the uterus, leuprolide helps stop anemia by decreasing the vaginal bleeding from these tumors. Iron supplements should be used to help treat the anemia.

When given to boys and girls experiencing early puberty, leuprolide slows down the development of the genital areas in both sexes and breast development in girls. This medicine delays puberty in a child only as long as the child continues to receive it.

Suppressing estrogen can cause thinning of the bones or slowing of their growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect in girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when leuprolide helps their bones grow at the proper and expected rate for children.

Leuprolide is available only with your doctor's prescription, in the following dosage form:

Parenteral
• Injection (U.S. and Canada)
• Implant (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For leuprolide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to leuprolide, buserelin, gonadorelin, histrelin, nafarelin, or to benzyl alcohol, a preservative present in some of the leuprolide products.

Pregnancy—Tell your doctor if you intend to have children.

• For men: Leuprolide may cause sterility which probably is only temporary. Be sure that you have discussed this with your doctor before receiving this medicine.
• For women: There is a chance that leuprolide may cause birth defects if it is taken after you become pregnant. It could also cause a miscarriage if taken during pregnancy. Stop using this medicine and tell your doctor immediately if you think you have become pregnant while receiving this medicine.

Breast-feeding—It is not known whether leuprolide passes into breast milk. However, use of leuprolide is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

Children—Leuprolide will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using leuprolide around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of leuprolide in the elderly to use in other age groups, it is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor and pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Changes in vaginal bleeding from an unknown cause (for use for endometriosis or anemia due to tumors of the uterus)—Leuprolide may delay diagnosis or worsen condition. The reason for the bleeding should be determined before leuprolide is used

• Conditions that increase the chances of developing thinning bones or
• Osteoporosis (brittle bones), history of, or family history of—It is important that your doctor know if you already have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, alcohol abuse, and a family history of osteoporosis or easily broken bones. Some medicines, such as corticosteroids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones when used for a long time

• Nerve problems caused by bone lesions in spine (for use for cancer of the prostate) and
• Problems in passing urine (for use for cancer of the prostate)—Conditions may get worse for a short time after leuprolide treatment is started

Leuprolide comes with patient directions. Read these instructions carefully .

Use the syringes provided in the kit. Other syringes may not provide the correct dose. These disposable syringes and needles are already sterilized and are designed to be used one time only and then discarded. If you have any questions about the use of disposable syringes, check with your health care professional.

Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much may increase the chance of side effects, while using too little may not improve your condition.

For adult patients receiving leuprolide for anemia caused by tumors of the uterus or for endometriosis :

• Leuprolide sometimes causes unwanted effects such as hot flashes or decreased interest in sex. It may also cause a temporary increase in pain when you first begin to use it. However, it is very important that you continue to use the medicine, even after you begin to feel better. Do not stop using this medicine without first checking with your doctor.

For adult patients receiving leuprolide for cancer of the prostate:

• Leuprolide sometimes causes unwanted effects such as hot flashes or decreased sexual ability. It may also cause a temporary increase in pain or difficulty in urinating, as well as temporary numbness or tingling of hands or feet or weakness when you first begin to use it. However, it is very important that you continue to use the medicine, even after you begin to feel better. Do not stop using this medicine without first checking with your doctor.

Dosing—

The dose of leuprolide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of leuprolide. If your dose is different, do not change it unless your doctor tells you to do so:

• For short-acting (daily) injection dosage forms:
  • For cancer of the prostate:
    • Adults—1 milligram (mg) injected under the skin once a day.
  • For central precocious puberty:
    • Children—Dose is based on body weight and must be determined by your doctor. It is injected under the skin once a day. The dose should be changed over time as weight changes.

• For long-acting (1-month) injection dosage forms:
  • For anemia caused by tumors of the uterus:
    • Adults—3.75 milligrams (mg) injected into a muscle once a month for up to three months.
  • For cancer of the prostate:
    • Adults—7.5 milligrams (mg) injected into a muscle or under the skin (depending on the specific product used) once a month.
  • For central precocious puberty:
    • Children—Dose is based on body weight and must be determined by the doctor. It is injected into a muscle once a month. The dose should be changed over time as weight changes.
  • For endometriosis:
    • Adults—3.75 milligrams (mg) injected into a muscle once a month for up to six months.

• For long-acting (3-month) injection dosage forms:
  • For anemia caused by tumors of the uterus:
    • Adults—11.25 milligrams (mg) injected into a muscle as a single injection to last for three months.
  • For cancer of the prostate:
    • Adults—22.5 milligrams (mg) injected into a muscle or under the skin (depending on the specific product used) once every three months.
  • For endometriosis:
    • Adults—11.25 milligrams (mg) injected into a muscle once every three months for up to six months.

• For long-acting (4-month) injection dosage form:
  • For cancer of the prostate:
    • Adults—30 milligrams (mg) injected into a muscle or under the skin (depending on the specific product used) once every four months.

• For long-acting (12-month)implant dosage form:
  • For cancer of the prostate:
    • Adults—one implant every 12 months.

Missed dose—

If you are using this medicine every day and you miss a dose, give it as soon as possible. However, if you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you are using this medicine once a month or every 3 to 12 months and you miss a dose, receive it as soon as possible, and go back to your regular dosing schedule.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Dispose of used syringes properly in the container provided. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

For patients receiving leuprolide for endometriosis or for anemia caused by tumors of the uterus :

• During the time you are receiving leuprolide, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstruation does not begin within 60 to 90 days after you stop receiving this medicine, check with your doctor.
• During the time you are receiving leuprolide, you should use birth control methods that do not contain hormones. If you have any questions about this, check with your health care professional.
• If you suspect you may have become pregnant, stop using this medicine and check with your doctor. There is a chance that continued use of leuprolide during pregnancy could cause birth defects or a miscarriage.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following side effects occur:

• For adults
  • Less common
    • Fast or irregular heartbeat 
    
    
  • Rare
    • Bone, muscle, or joint pain;  fainting ;  fast or irregular breathing;  numbness or tingling of hands or feet;  puffiness or swelling of the eyelids or around the eyes;  shortness of breath;  skin rash, hives, and/or itching;  sudden, severe decrease in blood pressure and collapse;  tightness in chest or wheezing;  troubled breathing 
    
    

• For males only (adults)
  • Rare
    • Pains in chest;  pain in groin or legs (especially in calves of legs) 
    
    

Check with your doctor as soon as possible if any of the following side effects occur:

• For females only (adults)
  • Rare
    • Anxiety;  deepening of voice;  increased hair growth;  mental depression ;  mood changes;  nervousness  
    
    

• For children
  • Rare
    • Body pain;  burning, itching, redness, or swelling at place of injection;  skin rash 
    
    

• For females only (children)—expected in first few weeks
  • Rare
    • Vaginal bleeding (continuing);  white vaginal discharge (continuing) 
    
    

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• For adults
  • More common
    • Sudden sweating and feelings of warmth (also called hot flashes)  
    
    
  • Less common
    • Blurred vision;  bleeding, bruising, burning, itching, pain, redness, or swelling at place of injection;  decreased interest in sexual intercourse;  dizziness;  headache;  nausea or vomiting;  swelling of feet or lower legs;  swelling or increased tenderness of breasts;  trouble in sleeping;  weight gain 
    
    

• For females only (adults)
  • More common
    • Light, irregular vaginal bleeding;  stopping of menstrual periods 
    
    
  • Less common
    • Burning, dryness, or itching of vagina;  pelvic pain 
    
    

• For males only (adults)
  • Less common
    • Bone pain;  constipation;  decreased size of testicles;  inability to have or keep an erection 
    
    

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, leuprolide is used in certain patients with the following medical condition:

• Cancer of the breast

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.