Description
Leuprolide acetate injection is used to treat central precocious puberty (CPP), a condition which causes early puberty in males (before 9 years of age) and females (before 8 years of age).
Leuprolide acetate is a synthetic (man-made) hormone that is similar to a natural hormone that is produced in the brain. 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:
- Solution
- Powder for Suspension, 6 Month
- Powder for Suspension, 1 Month
- Powder for Suspension, 3 Month
- Powder for Suspension, 4 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 acetate injection in children. Safety and efficacy have been established.
Geriatric
No information is available on the relationship of age to the effects of leuprolide acetate injection 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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Bepridil
- Cisapride
- Dengue Tetravalent Vaccine, Live
- Dronedarone
- Levoketoconazole
- Measles Virus Vaccine, Live
- Mesoridazine
- Mumps Virus Vaccine, Live
- Pimozide
- Piperaquine
- Rubella Virus Vaccine, Live
- Saquinavir
- Smallpox Monkeypox Vaccine
- Sparfloxacin
- Terfenadine
- Thioridazine
- Typhoid Vaccine
- Varicella Virus Vaccine, Live
- Yellow Fever Vaccine
- 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
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Astemizole
- Atazanavir
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cholera Vaccine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clothiapine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desflurane
- Desipramine
- Deslorelin
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:
- Benzyl alcohol allergy—This medicine may cause an allergic reaction.
- Brain tumor, history of or
- Seizures or epilepsy, history of or
- Stroke, history of—Use with caution. May cause side effects to become worse.
- Depression, history of or
- Mental illness, history of—Use with caution. May make these conditions worse.
Proper Use
This medicine is given as a shot under your skin in the stomach or thigh. It may sometimes be given at home to patients who do not need to be in the hospital or clinic. If you are using this medicine at home, your doctor or nurse will teach you how to prepare and inject the medicine. Be sure that you understand how to use this medicine.
If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself or your child a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into skin areas that are tender, bruised, red, hard, or has moles, scars, or birthmarks.
This medicine may come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.
To use the prefilled pen:
- Wash your hands before and after using the medicine.
- Do not use the pen if it appears broken or damaged. Do not put the pen in water or let water touch the pen.
- Pull the cap straight off. Check the liquid in the pen. It should be clear and colorless. Do not use it if the medicine is cloudy, discolored, or if it has lumps or particles in it.
- Attach a new needle. Push the capped needle straight down onto the pen and screw on until it feels snug. Do not over-tighten. Pull of the outer needle cover.
- Prime the new pen by turning the knob to "P". Press the injection button until it stops. You should see "0" in the dose window.
- You should see a stream of medicine from the needle. If you do not see the medicine, repeat the priming steps up to 3 times. Do not use the pen if there is still no medicine at the needle tip and use a new pen.
- Turn the dose knob to the prescribed dose. Insert the needle into the skin. Slowly press the injection button all the way down until it stops and you see "0" in the dose window. Slowly count to 15 to make sure you receive the full dose. Remove the pen.
- Use a new needle each time you give an injection. Always remove and throw the needle after each injection. Store the pen without a needle attached.
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 (solution):
- For central precocious puberty:
- Children—Dose is based on body weight and must be determined by your doctor. Your doctor may adjust the dose as needed.
- Weighing more than 48 kilograms (kg)—2.8 milligrams (mg) injected under the skin once a day.
- Weighing more than 40 kg to 48 kg—2.4 mg injected under the skin once a day.
- Weighing more than 32 kg to 40 kg—2 mg injected under the skin once a day.
- Weighing more than 24 kg to 32 kg—1.6 mg injected under the skin once a day.
- Weighing more than 16 kg to 24 kg—1.2 mg injected under the skin once a day.
- Weighing 16 kg or less—0.8 mg injected under the skin once a day.
- Children—Dose is based on body weight and must be determined by your doctor. Your doctor may adjust the dose as needed.
- For central precocious puberty:
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.
Do not use the pen for more than 28 days after first use.
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 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.
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 (non-hormonal method) to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
During the first 2 to 4 weeks of treatment, you may notice more signs of puberty, including vaginal bleeding, breast enlargement, and growth of testicles. If your child's symptoms do not improve after 2 months of treatment, or if they get worse, call your doctor.
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 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.
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. These may be symptoms of intracranial hypertension or pseudotumor cerebri (increased pressure in the head) in children.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
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:
More common
- Crying
- depersonalization
- dysphoria
- euphoria
- feeling faint, dizzy, or light-headedness
- feeling of warmth or heat
- flushing or redness of the skin, especially on face and neck
- headache
- heavy nonmenstrual vaginal bleeding
- itching of the vagina or genital area
- mental depression
- pain during sexual intercourse
- paranoia
- quick to react or overreact emotionally
- rapidly changing moods
- sweating
- thick, white vaginal discharge with no odor or with a mild odor
Less common
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- changes in menstrual periods
- chest pain, discomfort, or tightness
- cold hands and feet
- decreased sexual ability in males
- dry, puffy skin
- enlarged
- feeling cold
- increase in body movements
- loss of bladder control
- nervousness
- pounding in the ears
- rapid weight gain
- sleepiness or unusual drowsiness
- slow or irregular heartbeat
- swelling of front part of the neck
- tingling of hands or feet
- trouble breathing
- unusual tiredness or weakness
- unusual weight gain or loss
Incidence not known
- Anger
- blistering, peeling, or loosening of the skin
- breast enlargement
- burning, numbness, tingling, or painful sensations
- change in ability to see colors, especially blue or yellow
- chills
- confusion
- cough
- crying
- diarrhea
- difficulty swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- double vision
- dry mouth
- eye pain
- flushed, dry skin
- fruit-like breath odor
- hives, itching, skin rash
- increased hunger
- increased thirst
- increased urination
- irritability
- joint or muscle pain
- muscle spasm or jerking of all extremities
- nausea and vomiting
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- 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
- stomach pain
- sudden loss of consciousness
- thoughts or attempts at killing oneself
- trouble sleeping
- unable to sleep
- unsteadiness or awkwardness
- weakness in the arms, hands, legs, or feet
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:
More common
- Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
- blemishes on the skin
- dandruff
- oily skin
- pimples
Less common
- Acid or sour stomach
- belching
- bleeding gums
- bloody nose
- constipation
- difficulty swallowing
- discoloration of the fingernails or toenails
- heartburn
- heavy bleeding
- increased appetite
- increased hair growth, especially on the face
- indigestion
- irritation in the mouth
- loss of thinning of the hair
- lower back or side pain
- mouth ulcers
- pain or tenderness around the eyes and cheekbones
- painful or difficult urination
- redness and swelling of the gums
- stomach discomfort or upset
- stuffy or runny nose
Incidence not known
- Increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
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.
DRG-80012056
