Eligard

1 What is Eligard?

Brand: Eligard, Lupron, Lupron Depot, Lupron Depot-Ped, Viadur

Generic: Leuprolide injection

Eligard 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.

2 What to Know Before Using

Before using Eligard, the risks of taking the medicine must be weighed against the good it will do. For this medicine, ensure that you inform 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:

  • 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. Geriatric 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 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.

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.

Understanding drug interactions is important since 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
  • Bepridil
  • Cisapride
  • Dronedarone
  • Mesoridazine Pimozide
  • Piperaquine
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • and 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
  • Arsenic Trioxide
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azithromycin
  • Bedaquiline
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clomipramine
  • Clozapine Crizotinib
  • Cyclobenzaprine
  • Dabrafenib
  • Dasatinib
  • Delamanid
  • Desipramine
  • Disopyramide
  • Dofetilide Dolasetron
  • Domperidone
  • Donepezil
  • Doxepin
  • Droperidol
  • Ebastine
  • Eribulin
  • Erythromycin
  • Escitalopram
  • Famotidine
  • Felbamate
  • Fingolimod
  • Flecainide
  • Fluconazole
  • Fluoxetine
  • Formoterol
  • Foscarnet
  • Fosphenytoin
  • Galantamine
  • Gatifloxacin
  • Gemifloxacin
  • Granisetron
  • Halofantrine
  • Haloperidol
  • Hydroquinidine
  • Hydroxychloroquine
  • Ibutilide
  • Iloperidone
  • Imipramine
  • Itraconazole
  • Ivabradine
  • Ketoconazole
  • Lapatinib
  • Levofloxacin
  • Lumefantrine
  • Mefloquine
  • Methadone
  • Metronidazole
  • Mifepristone
  • Mizolastine
  • Moxifloxacin
  • Nelfinavir
  • Nilotinib
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Olanzapine
  • Ondansetron
  • Paliperidone
  • Panobinostat
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pentamidine
  • Perflutren
  • Lipid Microsphere
  • Perphenazine
  • Pipamperone
  • Posaconazole
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Promethazine
  • Propafenone
  • Protriptyline
  • Quetiapine
  • Quinidine
  • Quinine
  • Ranolazine
  • Rilpivirine
  • Risperidone
  • Ritonavir
  • Sertindole
  • Sevoflurane
  • Sodium Phosphate
  • Sodium Phosphate
  • Dibasic Sodium Phosphate
  • Monobasic Solifenacin
  • Sorafenib
  • Sotalol
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Telaprevir
  • Telavancin
  • Telithromycin
  • Tetrabenazine
  • Tizanidine
  • Tolterodine
  • Toremifene
  • Trazodone,
  • Trimipramine
  • Vandetanib
  • Vardenafil
  • Vemurafenib
  • Venlafaxine
  • Vilanterol,
  • Vinflunine
  • Voriconazole and
  • Vorinostat

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: Benzyl alcohol allergy. One of the Lupron injection products for children may cause an allergic reaction. Diabetes or hyperglycemia (high sugar in the blood) or osteoporosis (thinning of the bones) or Seizures or epilepsy, and history of or stroke.

This medicine needs to be used with caution. These medicine may make this conditions worse. Congestive heart failure 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), use the medicine with cautions. May cause side effects to become worse

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3 Proper Usage

Eligard is used as a shot under your skin or into a muscle. A nurse or other trained health professional may give you this medicine. 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.
  • 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.
  • 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 these instructions carefully. 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.

For cancer of the prostate: 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 in children 2 years of age and older, the dose is based on body weight and must be determined by your doctor. The starting dose for the once daily product is 50 micrograms (mcg) per kilogram (kg) of body weight injected under the skin once a day. The starting dose for the once monthly products is 0.3 milligram (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 adjust the dose as needed. When using the medicine in children younger than 2 years of age, use of this medicine is not recommended. 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 this medicine 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

4 Precautions to Take

In using Eligard, you must be careful and take some precautions as advised by your doctor.

Regular checkups for progress of you or your child at regular visits is important 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. Report to 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); 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.

Patients receiving leuprolide for endometriosis or for anemia caused by tumors of the uterus, in the first few days of treatment, the symptoms of your condition may get worse. This is normal and you must 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 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.

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 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, 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.

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.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Eligard.

It is known that not all of these side effects may occur, when they do occur, they may need medical attention. Check with your doctor immediately if any of the following side effects occur.

In adults:

The less common side effects will present as:

Rare side effects include:

  • 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):

The more common side effects include:

  • 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:

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 side effects include:

  • Light, irregular vaginal bleeding
  • Stopping of menstrual periods

Less common side effects will include:

  • Burning
  • Dryness or itching of the vagina
  • Pelvic pain

In males only (adults):

The most common side effects may include:

  • 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

The less common side effects:

  • 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.

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