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.

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