Health Guide
Drug Guide

Leuprolide (Intradermal route, intramuscular route, subcutaneous route)

Pronunciation:

LOO-proe-lide

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Antineoplastic Agent

Pharmacologic

Luteinizing Hormone Releasing Hormone Agonist

Uses of This Medicine:

Leuprolide injection is a synthetic (man-made) hormone that is similar to a natural hormone that is produced in the brain. It is used to treat a number of medical problems such as:

When given regularly to men, leuprolide decreases testosterone levels. Reducing the amount of testosterone in the body helps treat cancer of the prostate.

When given regularly to women, leuprolide decreases estrogen levels. Reducing the amount of estrogen in the body helps treat endometriosis. Leuprolide will also shrink tumors in the uterus, which decreases vaginal bleeding and helps prevent anemia.

When given regularly to boys and girls who have early puberty, leuprolide slows development of the genital area for both sexes. Leuprolide will also slow breast development in girls. This medicine will delay puberty only as long as the child continues to receive it.

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 conditions:

Before Using This Medicine:

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.

Children

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 for central precocious puberty soon after the child stops using it, and puberty will advance normally.

Appropriate studies have not been performed on the relationship of age to the effects of Eligard®, Lupron®, 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.

Older adults

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Eligard®, Lupron®, 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 Viadur® in the elderly.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies 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

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other 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. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Other interactions

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:

Proper Use of This Medicine:

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):

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

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

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.

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

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.

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

After the injection is prepared, the solution must be used right away and not stored. 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 This Medicine:

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.

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.

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.

Patients receiving leuprolide for central precocious puberty (CPP):

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

Patients receiving leuprolide for advanced prostate cancer:

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.

Side Effects of This Medicine:

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 adults
Less 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
skin rash, hives, or itching
sudden, severe decrease in blood pressure and collapse
tightness in the chest
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 children
Rare
Body pain
burning, itching, redness, or swelling at the injection site
skin rash
For females only (children) expected in first few weeks
Rare
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 adults
More 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 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
sore throat
sudden sweating
trouble sleeping
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.


Last Updated: 10/12/2016

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