LEUPROLIDE (Systemic)
Some commonly used brand names are:
In the U.S.?
- Eligard
- Lupron
- Lupron Depot
- Lupron Depot-Ped
- Lupron Depot-3 Month 11.25 mg
- Lupron Depot-3 Month 22.5 mg
- Lupron Depot-4 Month 30 mg
- Viadur
In Canada?
- Eligard
- Lupron
- Lupron Depot
- Lupron-3 Month SR Depot 22.5 mg
Another commonly used name is leuprorelin.
Category
- Antiendometriotic agent
- Antineoplastic
- Gonadotropin-releasing hormoneanalog
- Gonadotropin inhibitor
Description
Leuprolide (loo-PROE-lide) may be used for a numberof 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 pubertyin 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 hypothalamusgland.
When given regularly to men and boys, leuprolide decreases testosteronelevels. Reducing the amount of testosterone in the body is one way of treatingcancer of the prostate.
When given regularly to women and girls, leuprolide decreases estrogenlevels. Reducing the amount of estrogen in the body is one way of treatingendometriosis. By shrinking tumors in the uterus, leuprolide helps stop anemiaby decreasing the vaginal bleeding from these tumors. Iron supplements shouldbe used to help treat the anemia.
When given to boys and girls experiencing early puberty, leuprolide slowsdown the development of the genital areas in both sexes and breast developmentin girls. This medicine delays puberty in a child only as long as the childcontinues to receive it.
Suppressing estrogen can cause thinning of the bones or slowing of theirgrowth. This is a problem for adult women whose bones are no longer growinglike the bones of children. Slowing the growth of bones is a positive effectin 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 leuprolidehelps their bones grow at the proper and expected rate for children.
Leuprolide is available only with your doctor's prescription, in the followingdosage form:
Parenteral- Injection (U.S. and Canada)
- Implant (U.S.)
Before Using This Medicine
In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For leuprolide, thefollowing should be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic 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 thismedicine.
- For women: There is a chance that leuprolide may cause birth defectsif it is taken after you become pregnant. It could also cause a miscarriageif taken during pregnancy. Stop using this medicine andtell your doctor immediately if you think you have become pregnantwhile receiving this medicine.
Breast-feeding?It is not known whether leuprolide passes intobreast milk. However, use of leuprolide is not recommended during breast-feedingbecause it may cause unwanted effects in nursing babies.
Children?Leuprolide will stop having an effect on a childtreated for central precocious puberty soon after the child stops using it,and puberty will advance normally. It is not known if using leuprolide aroundthe time of puberty causes changes in boys' and girls' future abilities tohave 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 goodthat this medicine may do as well as the risks of using it.
Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of leuprolide in the elderly to use in other age groups, itis not expected to cause different side effects or problems in older peoplethan it does in younger adults.
Other medicines?Although certain medicines should not be usedtogether at all, in other cases two medicines may be used together even ifan interaction might occur. In these cases, your doctor may want to changethe dose, or other precautions may be necessary. Tell your doctor and pharmacistif you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.
Other medical problems?The presence of other medicalproblems may affect the use of leuprolide. Make sure you tell your doctorif you have any other medical problems, especially:
- Changes in vaginal bleeding from an unknown cause (for use for endometriosisor anemia due to tumors of the uterus)?Leuprolide may delay diagnosisor worsen condition. The reason for the bleeding should be determined beforeleuprolide is used
- Conditions that increase the chances of developing thinning bonesor
- Osteoporosis (brittle bones), history of, or family history of?Itis important that your doctor know if you already have an increased risk ofosteoporosis. Some things that can increase your risk for having osteoporosisinclude cigarette smoking, alcohol abuse, and a family history of osteoporosisor easily broken bones. Some medicines, such as corticosteroids (cortisone-likemedicines) or anticonvulsants (seizure medicine), can also cause thinningof the bones when used for a long time
- Nerve problems caused by bone lesions in spine (for use for cancerof the prostate) and
- Problems in passing urine (for use for cancer of the prostate)?Conditionsmay get worse for a short time after leuprolide treatment is started
Proper Use of This Medicine
Leuprolide comes with patient directions. Read these instructions carefully.
Use the syringes provided in the kit. Other syringes may not provide thecorrect dose. These disposable syringes and needles are already sterilizedand are designed to be used one time only and then discarded. If you haveany questions about the use of disposable syringes, check with your healthcare 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 doctorordered. 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 littlemay not improve your condition.
For adult patients receiving leuprolide for anemiacaused by tumors of the uterus or for endometriosis:
- Leuprolide sometimes causes unwanted effects such as hot flashesor decreased interest in sex. It may also cause a temporary increase in painwhen you first begin to use it. However, it is very important that you continueto 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 cancerof the prostate:
- Leuprolide sometimes causes unwanted effects such as hot flashesor decreased sexual ability. It may also cause a temporary increase in painor difficulty in urinating, as well as temporary numbness or tingling of handsor feet or weakness when you first begin to use it. However, it is very importantthat you continue to use the medicine, even after you begin to feel better. Do not stop using this medicine without first checkingwith your doctor.
Dosing?The dose of leuprolide will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 dosageforms:
- 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 determinedby your doctor. It is injected under the skin once a day. The dose shouldbe changed over time as weight changes.
- For long-acting (1-month) injection dosageforms:
- For anemia caused by tumors of the uterus:
- Adults?3.75 milligrams (mg) injected into a muscle once a monthfor up to three months.
- For cancer of the prostate:
- Adults?7.5 milligrams (mg) injected into a muscle or underthe skin (depending on the specific product used) once a month.
- For central precocious puberty:
- Children?Dose is based on body weight and must be determinedby the doctor. It is injected into a muscle once a month. The dose shouldbe changed over time as weight changes.
- For endometriosis:
- Adults?3.75 milligrams (mg) injected into a muscle once amonth for up to six months.
- For long-acting (3-month) injection dosageforms:
- For anemia caused by tumors of the uterus:
- Adults?11.25 milligrams (mg) injected into a muscle as a singleinjection to last for three months.
- For cancer of the prostate:
- Adults?22.5 milligrams (mg) injected into a muscle or underthe skin (depending on the specific product used) once every three months.
- For endometriosis:
- Adults?11.25 milligrams (mg) injected into a muscle once everythree months for up to six months.
- For long-acting (4-month) injection dosageform:
- For cancer of the prostate:
- Adults?30 milligrams (mg) injected into a muscle or under theskin (depending on the specific product used) once every four months.
- For long-acting (12-month)implant dosageform:
- For cancer of the prostate:
- Adults?one implant every 12 months.
Missed dose?If you are using this medicine every day and youmiss a dose, give it as soon as possible. However, if you do not rememberuntil the next day, skip the missed dose and go back to your regular dosingschedule. Do not double doses.
If you are using this medicine once a month or every 3 to 12 months andyou miss a dose, receive it as soon as possible, and go back to your regulardosing 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. Disposeof used syringes properly in the container provided. Be sure that any discardedmedicine is out of the reach of children.
Precautions While Using This Medicine
It is very important that your doctor check your progress atregular visits to make sure that this medicine is working properlyand 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 periodmay not be regular or you may not have a menstrual period at all. This isto be expected when being treated with this medicine. If regular menstruationdoes 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 birthcontrol methods that do not contain hormones. If you have any questions aboutthis, 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 chancethat continued use of leuprolide during pregnancy could cause birth defectsor a miscarriage.
Side Effects of This Medicine
Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects 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
Rare
Bone, muscle, or joint pain; fainting; fast or irregular breathing; numbness or tingling of hands or feet; puffinessor swelling of the eyelids or around the eyes; shortnessof breath; skin rash, hives, and/or itching; sudden, severe decrease in blood pressure and collapse; tightness in chest or wheezing; troubledbreathing
Unknown?Observed durring clinical practice, estimates of frequencycan not be determined
Check with your doctor as soon as possible if any of the followingside effects occur:
Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:
For adults
Less common
Blurred vision; bleeding, bruising,burning, itching, pain, redness, or swelling at place of injection; decreased interest in sexual intercourse; dizziness; headache; nausea ; swelling of feet or lower legs; swelling or increased tenderness of breasts; trouble in sleeping; weight gain
Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.
Additional Information
Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,leuprolide is used in certain patients with the following medical condition:
Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.
Revised: 11/29/2005
