Eligard

Generic Name: leuprolide (Intradermal route, Intramuscular route, Subcutaneous route)

LOO-proe-lide AS-e-tate

Commonly used brand name(s)

In the U.S.

• Eligard


• Lupron


• Lupron Depot


• Lupron Depot-Ped


• Viadur

Available Dosage Forms:

• Powder for Solution


• Powder for Suspension, 3 Month


• Solution


• Powder for Suspension, 1 Month


• Powder for Suspension, 6 Month


• Kit


• Powder for Suspension, 4 Month


• Powder for Suspension

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Leuprolide

Uses For Eligard

Leuprolide is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. It is used to treat a number of medical problems. These include:

• Anemia caused by bleeding of uterine leiomyomas (tumors in the uterus).


• Cancer of the prostate, advanced.


• 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.

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, 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 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.

This medicine is available only with your doctor's prescription.

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.

Before Using Eligard

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of leuprolide pediatric injection in children. However, use is not recommended in children younger than 2 years of age. Leuprolide pediatric injection 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 benefit of this medicine as well as the risk of using it.

Appropriate studies have not been performed on the relationship of age to the effects of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, Lupron Depot®-6 month, or Viadur® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month in the elderly.

No information is available on the relationship of age to the effects of leuprolide pediatric injection and Viadur® in geriatric patients.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	X	Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different 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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Benzyl alcohol allergy, history of—Using Lupron® injection (certain brand) may cause a skin reaction.

• Brain problems (e.g., brain tumors), history of or


• Pituitary gland problem or


• Seizures or epilepsy, history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• 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 (thinning of the bones), 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.

• Congestive heart failure or


• Diabetes or


• Electrolyte imbalance or


• Heart or blood vessel disease or


• Heart rhythm problems (e.g., congenital long QT syndrome) or


• Hyperglycemia (high sugar in the blood)—Use with caution. May make these conditions worse in patients treated for prostate cancer.

• Nerve problems caused by bone lesions in the spine (in treatment of cancer of the prostate) or


• Problems in passing urine (in treatment cancer of the prostate)—Conditions may get worse for a short time after leuprolide treatment is started. Your doctor will want to follow your condition carefully.

Proper Use of leuprolide

This section provides information on the proper use of a number of products that contain leuprolide. It may not be specific to Eligard. Please read with care.

For leuprolide injections (Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-Ped 1-month or 3-month, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month):

• A nurse or other trained health professional may give you this medicine. This medicine is given as a shot under your skin or into a muscle.


• You may be taught how to give this medicine at home. Make sure you understand all of the instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.


• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas.


• Use a new needle and syringe each time you inject your medicine.


• Before each injection, look carefully at the medicine to check for any particles or a change in color. You should not use medicine that has changed color or has particles in it.


• If you have any questions about any of this, check with your doctor.

Each package of leuprolide injection contains patient directions. Read the instructions carefully and make sure you understand:

• How to prepare the injection.


• Proper use of disposable syringes.


• How to give the injection.


• How long the injection is stable.

The long-acting form of this medicine (depot) may be given once every month or once every 3 to 12 months. Your schedule depends on the reason you are using this medicine. To stay on the right schedule with the medicine, make sure you keep all appointments.

If you are to receive the leuprolide implant (Viadur®):

• Viadur® is an implant that is surgically placed under the skin of the upper arm. Your doctor will treat the arm with numbing medicine and then cut a small incision to insert the implant with a special tool. The incision will be closed with surgical strips. An adhesive bandage will be placed over the arm and should be left on for 24 hours.


• After the implant is put in place, you should keep the arm clean and dry, and should not swim or bathe for 24 hours. You should avoid any heavy lifting or strenuous exercise for 48 hours after the implant is put into the arm.


• The surgical strips can be removed after at least 3 days or as soon as the incision is healed.


• The implant will be left in place for one year and then removed. If needed, your doctor will then insert a new implant to continue treatment for another year.


• Viadur® comes with patient instructions. Read these instructions carefully.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

Dosing

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For cancer of the prostate:
  
  • The dose varies depending on the specific product used.
  
  


• For central precocious puberty:
  
  • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose for the once daily product is 50 microgram (mcg) per kilogram (kg) of body weight injected under the skin once a day. The starting dose for the once monthly product is 0.3 milligrams (mg) per kg of body weight or 7.5 mg, 11.25 mg, or 15 mg injected into a muscle every 4 weeks. The 3-month product dose is 11.25 mg or 30 mg injected into a muscle as a single injection every 12 weeks. Your doctor may increase your dose as needed.
  
  
  • Children younger than 2 years of age—Use is not recommended.
  
  


• For anemia caused by tumors of the uterus or endometriosis:
  
  • Adults—The dose given depends on the specific product used. Some examples are 3.75 milligrams (mg) injected into a muscle once a month for up to 3 months or 11.25 mg injected into a muscle as a single injection to last for 3 months. .
  
  

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

The mixed suspension should be discarded if not used right away. Eligard® must be used within 30 minutes after mixing, and Lupron Depot® must be used within 2 hours after mixing.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using Eligard

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

For female patients: You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

For patients receiving leuprolide for central precocious puberty (CPP):

• If you are a female patient, you may have occasional bleeding or spotting. If you continue to have heavy bleeding or regular periods after 2 months of using this medicine, call your doctor.


• If you develop a rash or irritation at the injection site, check with your doctor right away.

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

• For the first few days of treatment, the symptoms of your condition may get worse. This is normal. Do not stop taking this medicine. Talk with your doctor if you have concerns about this.


• 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 doctor.


• 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.

When you first start using this medicine for prostate cancer treatment, some of your symptoms might get worse for a short time. You might also have new symptoms. You might have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. These symptoms should improve within a few weeks. Tell your doctor if you have any new symptoms or your symptoms get worse.

Patients receiving leuprolide for advanced prostate cancer:

• This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.


• This medicine may increase your risk of having a heart attack or stroke. Check with your doctor right away if you are having chest pain or discomfort; pain or discomfort in the arms, jaw, back, or neck; confusion; shortness of breath; nausea or vomiting, or sweating.


• This medicine can cause changes in heart rhythms, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

This medicine can cause decreases in bone mineral density, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.

Do not stop using or changing the dose of Lupron® injection without checking first with your doctor.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Eligard Side Effects

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.

Check with your doctor immediately if any of the following side effects occur:

For adultsLess common

• Fast or irregular heartbeat

Rare

• Bone, muscle, or joint pain


• fainting


• fast or irregular breathing


• numbness or tingling of the hands or feet


• puffiness or swelling of the eyelids or around the eyes


• shortness of breath


• skin rash, hives, or itching


• sudden, severe decrease in blood pressure and collapse


• tightness in the chest or wheezing


• troubled breathing

For males only (adults)More common

• Arm, back, or jaw pain


• bloody or cloudy urine


• blurred vision


• burning while urinating


• chest pain or discomfort


• chest tightness or heaviness


• difficult or labored breathing


• difficult, burning, or painful urination


• difficulty with moving


• dizziness


• frequent urge to urinate


• headache


• increased urge to urinate during the night


• muscle pain or stiffness


• nausea


• nervousness


• pain in the joints


• pale skin


• pounding in the ears


• slow or fast heartbeat


• sweating


• troubled breathing with exertion


• unusual bleeding or bruising


• unusual tiredness or weakness


• waking to urinate at night

Rare

• Pain in the groin or legs (especially in the calves of the legs)

Incidence not known

• Altered mental status


• cardiovascular collapse


• double vision


• visual changes


• vomiting

For females only (adults)Rare

• Anxiety


• deepening of voice


• increased hair growth


• mental depression


• mood changes

For childrenRare

• Body pain


• burning, itching, redness, or swelling at the injection site


• skin rash

For females only (children)—expected in first few weeksRare

• Vaginal bleeding (continuing)


• white vaginal discharge (continuing)

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For adultsMore common

• Sudden sweating and feelings of warmth (also called hot flashes)

Less common

• Bleeding, bruising, burning, itching, pain, redness, or swelling at the injection site


• decreased interest in sexual intercourse


• swelling of the feet or lower legs


• swelling or increased tenderness of the breasts


• trouble with sleeping


• weight gain

For females only (adults)More common

• Light, irregular vaginal bleeding


• stopping of menstrual periods

Less common

• Burning, dryness, or itching of the vagina


• pelvic pain

For males only (adults)More common

• Back pain


• chills


• constipation


• cough


• diarrhea


• fever


• general feeling of discomfort or illness


• loss of appetite


• pain or discomfort at the injection site


• redness of the face, neck, arms, and occasionally, upper chest


• runny nose


• shivering


• sleeplessness


• sore throat


• sudden sweating


• trouble sleeping


• unable to sleep


• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Less common

• Bone pain


• decreased size of the testicles


• inability to have or keep an erection

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Eligard side effects (in more detail)

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More Eligard resources

• Eligard Side Effects (in more detail)
• Eligard Use in Pregnancy & Breastfeeding
• Eligard Drug Interactions
• Eligard Support Group
• 2 Reviews for Eligard - Add your own review/rating

• Eligard Prescribing Information (FDA)


• Eligard Kit MedFacts Consumer Leaflet (Wolters Kluwer)


• Eligard Consumer Overview


• Leuprolide Prescribing Information (FDA)


• Leuprolide MedFacts Consumer Leaflet (Wolters Kluwer)


• Leuprolide Acetate Monograph (AHFS DI)


• Lupron Consumer Overview


• Lupron Depot MedFacts Consumer Leaflet (Wolters Kluwer)


• Lupron Depot Prescribing Information (FDA)


• Lupron Depot-PED Prescribing Information (FDA)


• Lupron Depot-PED Kit MedFacts Consumer Leaflet (Wolters Kluwer)


• Viadur Prescribing Information (FDA)


• Viadur Implant MedFacts Consumer Leaflet (Wolters Kluwer)

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