Viadur (Intradermal, Intramuscular, Subcutaneous)

Leuprolide injection is a man-made hormone that is similar to a natural hormone made in the brain. It is used to treat several medical issues including:

• Anemia caused by bleeding from uterine leiomyomas (fibroid tumors in the uterus), or
• Advanced or late-stage prostate cancer, or
• Central precocious puberty, which causes early puberty in boys (before 9 years old) and girls (before 8 years old), or
• Pain from endometriosis.

Lupron Depot® 11.25 mg is used along with norethindrone acetate to relieve and manage painful symptoms of endometriosis. It is also used with iron to treat bleeding in women with anemia caused by uterine leiomyomas before surgery. It is given to women who need 3 months of hormonal suppression.

When given regularly to men, leuprolide lowers testosterone levels. Lowering testosterone helps treat prostate cancer.

When given regularly to women, leuprolide lowers estrogen levels. Lowering estrogen helps treat endometriosis. Leuprolide will also shrink tumors in the uterus, reducing vaginal bleeding and helping prevent anemia.

When given regularly to boys and girls with 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.

It is very important for your doctor to check your or your child's progress at regular visits to ensure that this medicine is working correctly. Blood and urine tests may be needed to look for unwanted effects.

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

For female patients: You should not receive this medicine if you are pregnant or may become pregnant. Using this medicine while pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you may 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 show other abnormal behaviors. Make sure to inform the doctor if you have trouble sleeping, get upset easily, experience a large increase in energy, or start to act recklessly. 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, inform 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 spasms 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 experiences blurred or double vision, changes in ability to see colors, especially blue or yellow, persistent 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, your symptoms may worsen. This is normal. Do not stop using this medicine. Speak with your doctor if you have concerns about this.
• While receiving leuprolide, your menstrual period may not be regular or you may not have a menstrual period at all. This is expected during treatment with this medicine. If regular menstruation does not resume within 60 to 90 days after stopping this medicine, check with your doctor.
• This medicine can cause a decrease in your bone mineral density, which may lead to osteoporosis or weakened bones. Discuss with your doctor how this risk will affect you.
• While receiving leuprolide, you should use non-hormonal birth control methods (e.g., condoms, spermicide). If you have questions about this, check with your doctor.
• If you suspect you may be pregnant, stop using this medicine and check with your doctor immediately. Continued use of leuprolide during pregnancy could cause birth defects or a miscarriage.
• This medicine may cause some people to be agitated, irritable, or show other abnormal behaviors. Make sure to inform the doctor if you have trouble sleeping, get upset easily, experience a large increase in energy, or start to act recklessly. 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, inform 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 spasms or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.

Patients receiving leuprolide for advanced prostate cancer:

• Initially, some of your symptoms may worsen for a short time or you may experience new symptoms. You might have bone pain, back pain, tingling or numbness in the body, blood in the urine, or trouble urinating. Inform your doctor if you have any new symptoms or if your symptoms worsen.
• 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 immediately if you experience chest pain or discomfort, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, confusion, slurred speech, or weakness.
• This medicine can cause changes in your heart rhythm, including a condition called QT prolongation. It may alter the way your heart beats and cause fainting or serious side effects. Contact your doctor right away if you notice any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.
• This medicine can lead to a decrease in your bone mineral density, which may result in osteoporosis or weakened bones. Discuss with your doctor 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 spasms or jerking of the arms or legs, sudden loss of consciousness, or loss of bladder control.
• Some men who use this medicine have become infertile (unable to have children). Discuss with your doctor before using this medicine if you plan to have children.

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

In deciding to use a medicine, you and your doctor will need to consider the risks against the benefits it may provide. The following points should be taken into account for this medicine:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems that would limit the use of leuprolide pediatric injection in children. However, it is not recommended for children younger than 2 years. Leuprolide pediatric injection will stop being effective for central precocious puberty shortly after the child stops using it, and puberty will proceed normally.

Studies have not been conducted on how age affects the use 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 children. Safety and effectiveness have not been established.

Geriatric

Studies have not shown any specific problems that would limit the use of Camcevi™, Eligard®, Lupron®, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month in elderly patients.

Studies on how age affects the use of Lupron Depot® 11.25 mg have not been performed in older adults. This medicine is not intended for use in elderly women.

No information is available on how age affects the use of Fensolvi® or Lupron Depot-Ped® in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together with caution. If you are taking this medicine, it is very important for your healthcare provider to know if you are taking any of the medicines listed below. The following interactions are significant and are not necessarily a complete list.

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 necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both 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
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Methotrimeprazine
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moricizine
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Papaverine
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zotepine
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around meal times or with certain foods because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare provider about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may impact the use of this medicine. Be sure to inform 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 (e.g., low magnesium, potassium, or calcium) or
• Heart attack, history of or
• Heart or blood vessel disease or
• Heart rhythm problems (e.g., congenital long QT syndrome) or
• Seizures or epilepsy, history of or
• Sinusitis or history of or
• Stroke, history of—Use with caution. May worsen side effects.

• Benzyl alcohol allergy—One of the Lupron® injection products for children may cause an allergic reaction.

• Depression, history of or
• Diabetes or
• Hyperglycemia (high blood sugar) or
• Mental illness, history of or
• Osteoporosis (thinning of the bones)—Use with caution. May worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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
• Blurred vision
• Burning, numbness, tingling, or painful sensations
• Chest pain
• Cold, clammy, pale skin
• Confusion
• Dizziness or lightheadedness
• Double vision
• Dry mouth
• Flushed, dry skin
• Fruit-like breath odor
• Increased hunger
• Increased thirst
• Increased urination
• Irregular heartbeat
• Loss of consciousness
• Seizures
• Thoughts or attempts at killing oneself
• Unexplained weight loss
• Unsteadiness or awkwardness
• Visual changes
• Weakness in the arms, hands, legs, or feet

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. 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.

In the U.S.

• Camcevi
• Eligard
• Lupron
• Lupron Depot
• Lupron Depot-Ped
• Viadur

Available Dosage Forms:

• Emulsion
• Powder for Suspension, 4 Month
• Solution
• Powder for Suspension, 6 Month
• Powder for Suspension, 1 Month
• Powder for Suspension, 3 Month

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

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.

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.

• Will I get my period while on Lupron?
• What does Lupron do for IVF?
• Are Lupron Depot and Eligard the same drug?
• Can you get pregnant on Lupron Depot?
• Is Firmagon (degarelix) the same as Lupron Depot?