Description
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 including:
- Anemia caused by bleeding from uterine leiomyomas (fibroid tumors in the uterus), or
- Cancer of the prostate that is advanced or late-stage, or
- Central precocious puberty, a condition which causes early puberty in males (before 9 years of age) and females (before 8 years of age), or
- Pain due to endometriosis.
Lupron Depot® 11.25 mg is used in combination with norethindrone acetate to initially relieve and manage the reoccurrence of the painful symptoms of endometriosis. It is also used together with iron to treat bleeding in patients with anemia caused by uterine leiomyomas before a surgical procedure. It is given to females who need 3 months of hormonal suppression.
When given regularly to males, leuprolide decreases testosterone levels. Reducing the amount of testosterone in the body helps treat cancer of the prostate.
When given regularly to females, 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 males and females who have early puberty, leuprolide slows the development of the genital area for both sexes. Leuprolide will also slow breast development in females. 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.
This product is available in the following dosage forms:
- Emulsion
- Powder for Suspension, 4 Month
- Solution
- Powder for Suspension, 6 Month
- Powder for Suspension, 1 Month
- Powder for Suspension, 3 Month
Before Using
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 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 Camcevi™, Eligard®, Lupron®, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, Lupron Depot®-6 month, or Lupron Depot® 11.25 mg 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 Camcevi™, Eligard®, Lupron®, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month in the elderly.
Appropriate studies on the relationship of age to the effects of Lupron Depot® 11.25 mg have not been performed in the geriatric population. This medicine is not indicated for use in elderly female patients.
No information is available on the relationship of age to the effects of Fensolvi® or Lupron Depot-Ped® in the elderly.
Breastfeeding
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.
Drug Interactions
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.
- Bepridil
- Cisapride
- Dronedarone
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
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.
- Adagrasib
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
- Deslorelin
- Deutetrabenazine
- Dexmedetomidine
- Disopyramide
- Dofetilide
- Dolasetron
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:
- Abnormal or unusual vaginal bleeding—Lupron Depot® 11.25 mg injection should not be used in patients with this condition.
- Asthma or history of or
- Brain tumors, history of or
- Congestive heart failure or
- Drug allergy or history of or
- Electrolyte imbalance (eg, low magnesium, potassium, or calcium) or
- Heart attack, history of or
- Heart or blood vessel disease or
- Heart rhythm problems (eg, congenital long QT syndrome) or
- Seizures or epilepsy, history of or
- Sinusitis or history of or
- Stroke, history of—Use with caution. May cause side effects to become worse.
- Benzyl alcohol allergy—One of the Lupron® injection products for children may cause an allergic reaction.
- Depression, history of or
- Diabetes or
- Hyperglycemia (high sugar in the blood) or
- Liver disease or
- Mental illness, history of or
- Osteoporosis (thinning of the bones)—Use with caution. May make these conditions worse.
Proper Use
For leuprolide injections (Camcevi™, Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot® 11.25 mg, Lupron Depot-Ped®, 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. It is given as a shot under your skin or into a muscle. Leuprolide injection is given on different schedules for different conditions. It might be given every day, once a month, or every few months.
- Camcevi™ is given once every 6 months. The long-acting form (depot) may be given once every month or once every 3 to 12 months. To stay on the right schedule, make sure you keep all appointments.
- 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.
- Check the medicine before each injection. Do not use it if it is discolored, if there are particles in it, or if there is clumping or caking of the powder present.
- If you have any questions about any of these, check with your doctor.
Leuprolide injection may contain a Medication Guide or patient instructions. Read and follow these instructions carefully and make sure you understand:
- How to prepare the injection.
- How to use and dispose of the syringes.
- How to give the injection.
- How long the injection can be stored.
If you are using Lupron Depot® 11.25 mg together with norethindrone acetate, you should also read and understand the information and instructions about using norethindrone. The warnings and precautions on norethindrone will also apply to Lupron Depot® 11.25 mg.
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 injection dosage form:
- 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.
- Children—Use and dose must be determined by your doctor.
- For cancer of the prostate:
- Adults—The dose given depends on the specific product used. Some examples are 7.5 milligrams (mg) injected into a muscle or under the skin once a month, 22.5 mg injected into a muscle or under the skin as a single injection to last for 3 months, or 30 mg injected under the skin as a single injection to last for 4 months, or 45 mg injected under the skin as a single injection to last for 6 months.
- For central precocious puberty:
- Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. Your doctor may adjust the dose as needed. Lupron Depot-Ped® is given once a month, once every 3 months, or once every 6 months.
- Children younger than 2 years of age—Use and dose must be determined by your doctor.
- For initial and retreatment of endometriosis:
- Adults—11.25 milligrams (mg) injected into a muscle given for 1 to 2 doses every 3 months. The total treatment duration will last for 12 months.
- Children—Use and dose must be determined by your doctor.
- For anemia caused by tumors of the uterus or endometriosis:
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
It is very important that your doctor check the your or your child's progress 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 serious allergic reactions, including anaphylaxis, which can be life-threatening and require 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.
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. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
Patients receiving leuprolide for central precocious puberty (CPP):
- If you are a female patient, you may have occasional vaginal 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.
- This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
- Using this medicine may increase your risk of having seizures. Check with your doctor right away if you start to have convulsions, muscle spasm or jerking of all extremities, sudden loss of consciousness, or loss of bladder control.
- This medicine may cause intracranial hypertension or pseudotumor cerebri (increased pressure in the head) in children. Check with your doctor right away if your child has blurred or double vision, change in ability to see colors, especially blue or yellow, continuing ringing or buzzing or other unexplained noise in the ears, dizziness, eye pain, hearing loss, nausea and vomiting, or severe headache.
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 using 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.
- This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.
- During the time you are receiving leuprolide, you should use birth control methods that do not contain hormones (eg, condoms, spermicide). If you have any questions about this, check with your doctor.
- If you suspect that you may have become pregnant, stop using this medicine and check with your doctor right away. There is a chance that continued use of leuprolide during pregnancy could cause birth defects or a miscarriage.
- This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.
- Using this medicine may increase your risk of having seizures. Check with your doctor right away if you start to have convulsions, muscle spasm or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.
Patients receiving leuprolide for advanced prostate cancer:
- At first, some of your symptoms might get worse for a short time or you might have new symptoms. You might have bone pain, back pain, a tingling or numbness in the body, blood in the urine, or trouble urinating. Tell your doctor if you have any new symptoms or if your symptoms get worse.
- This medicine may increase your risk of high blood sugar or cholesterol levels, or non-alcoholic fatty liver disease. Check with your doctor if you notice a change in the results of your blood or urine sugar tests.
- 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, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, confusion, slurred speech, or weakness.
- Contact your doctor right away if you have any changes to your heart rhythm. You might feel dizzy or faint, or you might have a fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem, including QT prolongation.
- This medicine can cause your bone mineral density to decrease, which may lead to osteoporosis or weakened bones. Talk with your doctor about how this risk will affect you.
- Using this medicine may increase your risk of having seizures. Check with your doctor right away if you start to have convulsions, muscle spasm or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.
- Some males who use this medicine have become infertile (unable to have children). Talk with your doctor before using this medicine if you plan to have children.
This medicine may cause serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.
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
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
- chest tightness
- 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
- trouble breathing
For males only (adults)
More common
- Arm, back, or jaw pain
- bloody or cloudy urine
- blurred vision
- bone pain
- chest pain or discomfort
- 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 arms or legs
- pain in the joints
- pale skin
- pounding in the ears
- slow or fast heartbeat
- sweating
- unusual bleeding or bruising
- unusual tiredness or weakness
- waking to urinate at night
Rare
- Pain in the groin or legs (especially in the calves)
Incidence not known
- Altered mental status
- anxiety
- black, tarry stools
- blistering, peeling, or loosening of the skin
- blurred vision
- burning, numbness, tingling, or painful sensations
- chest pain
- chills
- cold, clammy, pale skin
- confusion
- cough
- dark urine
- diarrhea
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- dry mouth
- fever
- flushed, dry skin
- fruit-like breath odor
- increased hunger
- increased thirst
- increased urination
- irregular heartbeat
- itching
- joint or muscle pain
- light-colored stools
- loss of consciousness
- nausea and vomiting
- painful or difficult urination
- red irritated eyes
- red skin lesions, often with a purple center
- seizures
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- stomach pain
- swollen glands
- thoughts or attempts at killing oneself
- unexplained weight loss
- unsteadiness or awkwardness
- visual changes
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
For females only (adults)
Rare
- Anxiety
- deepening of voice
- increased hair growth
- mental depression
- mood changes
For children
More common
- Body aches or pain
- chest tightness
- chills
- cough
- cough producing mucus
- difficulty in breathing
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- noisy breathing
- pain or redness at the injection site
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common
- Irritability
- mood or mental changes
Rare
- Burning, itching, or swelling at the injection site
Incidence not known
- Blurred vision
- change in ability to see colors, especially blue or yellow
- nausea and vomiting
- seizures
- severe headache
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 feeling of warmth (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
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
Less common
- Decreased size of the testicles
- inability to have or keep an erection
Incidence not known
- Increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
For children
More common
- Constipation
- feeling of warmth
- redness of the face, neck, arms and occasionally, upper chest
- stomach pain
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.
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