What is Leuprolide?

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 boys (before 9 years of age) and girls (before 8 years of age), or
• Pain due to endometriosis.

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 the 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.

For leuprolide injections (Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot® 11.5 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. This medicine is given as a shot under your skin or into a muscle.
• 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 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 and follow these instructions carefully. Ask your doctor if you have any questions.

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

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.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

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.

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.

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:

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.

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, Lupron Depot® 11.5 mg, or Viadur® in the pediatric population. Safety and efficacy have not been established.

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.

Appropriate studies on the relationship of age to the effects of Lupron Depot® 11.5 mg have not been performed in the geriatric population. This medicine is not indicated for use in elderly women.

No information is available on the relationship of age to the effects of Lupron Depot-Ped® or Viadur® in the elderly.

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.

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.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• 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.

• Alfuzosin
• Amiodarone
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Delamanid
• Desipramine
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Eribulin
• Erythromycin
• Escitalopram
• Famotidine
• Felbamate
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Granisetron
• Halofantrine
• Haloperidol
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mizolastine
• Moxifloxacin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osimertinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Pimavanserin
• Pipamperone
• Pitolisant
• Posaconazole
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ranolazine
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Sertindole
• Sertraline
• Sevoflurane
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolterodine
• Toremifene
• Trazodone
• Trimipramine
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voriconazole
• Vorinostat
• Zuclopenthixol

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.

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—One of the Lupron® injection products 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)
• 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
• Mental illness, history of or
• Osteoporosis (thinning of the bones)—Use with caution. May make these conditions worse.

It is very important that your doctor check the you 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 a serious type of allergic reaction called anaphylaxis, which 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. 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.

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.
• 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. 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 all extremities, 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 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, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, confusion, shortness of breath, slurred speech, or weakness.
• This medicine can cause changes in your heart rhythm, including a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects. 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 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.
• If you plan to have children, talk with your doctor before using this medicine. You might have to wait for a period of time after the medicine is stopped to attempt to have children.

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.