What is enantone LP (leuprolide) used for?
Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. It works by decreasing levels of certain hormones produced by the testes and ovaries. This prevents the growth of certain tumors that need these hormones to grow.
Enantone LP is commonly used for treating symptoms of advanced prostate cancer. It may also be used for other conditions as determined by your doctor.
How should I take enantone LP (leuprolide)?
Use enantone LP as directed by your doctor. Ask your health care provider any questions you may have about how to use enantone LP.
Enantone LP is usually given every month (4 weeks) as an injection at your doctor’s office, hospital, or clinic. If you will be using leuprolide at home, a health care provider will teach you how to use it. Be sure you understand how to use leuprolide. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
Do not use enantone LP if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
How do I store enantone LP (leuprolide)?
Enantone LP is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store enantone LP in the bathroom or the freezer. There may be different brands of enantone LP that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.
You should not flush enantone LP down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.
Precautions & warnings
What should I know before using enantone LP (leuprolide)?
Before using enantone LP, tell your doctor if:
- You are allergic to any ingredient in leuprolide, to GnRH, or to another GnRH agonist (e.g., histrelin).
- You are pregnant, able to become pregnant, or are breastfeeding.
- You are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement.
- You have allergies to medicines, foods, or other substances.
- You are taking medicines that can weaken the bones, such as anticonvulsants (e.g., phenytoin) or corticosteroids (e.g., prednisone).
- You take any medicine that may increase the risk of a certain type of irregular heartbeat (prolonged QT interval) or seizures. Check with your doctor or pharmacist if you are unsure if any of your medicines may increase the risk of these problems.
Also, there is some important information that you may notice:
- Certain hormone levels may increase during the first few weeks of treatment with enantone LP. This may cause you to experience worsening symptoms or onset of new symptoms (e.g., bone pain; blood in the urine; difficulty urinating; burning, numbness, or tingling) during the first few weeks of treatment. Patients with growths on or near the spine or spinal cord, or a blockage of the bladder or ureters may be at greater risk of developing serious and sometimes fatal complications. Contact your doctor if any new or worsened symptoms occur while using enantone LP.
- Enantone LP lowers the amount of certain hormones in your body. This may cause certain expected side effects to occur, such as changes in breast size, breast soreness or tenderness, testicular changes, decreased sexual ability, hot flashes, or night sweats. Contact your doctor if you have questions or concerns or if you experience any of these side effects.
- Enantone LP may cause your bones to weaken or become more prone to fractures, especially if you use enantone LP for long periods of time. Contact your doctor if you experience bone pain or if you have concerns regarding changes in bone density.
- A slight increase in the risk of stroke or serious and sometimes fatal heart problems has been reported with the use of GnRH agonists in men. Although the risk appears to be low, seek immediate medical attention if you experience chest, jaw, or left arm pain; confusion; fainting; numbness of an arm or leg; one-sided weakness; slurred speech; sudden, severe headache or vomiting; or vision changes. Discuss any questions or concerns with your doctor.
- High blood sugar and an increased risk of the development of diabetes has been reported in men who use GnRH agonists. Patients who already have diabetes may develop trouble controlling their blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
- Diabetes patients: enantone LP may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
- A serious pituitary gland problem (pituitary apoplexy) has rarely been reported with the use of enantone LP. Most cases developed within 2 weeks after the first dose. Contact your doctor right away if you experience a sudden headache, vomiting, fainting, eye weakness, inability to move your eyes, mental status changes, or vision changes.
- Leuprolide may interfere with certain lab tests, including certain hormone and pituitary gland function tests. Be sure your doctor and lab personnel know you are using leuprolide.
- Lab tests, including blood testosterone levels, prostate-specific antigen (PSA), hemoglobin A1c, blood glucose, and bone density, may be performed while you use leuprolide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Leuprolide should not be used in children; safety and effectiveness in children have not been confirmed.
Is it safe during pregnancy or breastfeeding?
There are no adequate studies in women for determining risk when using this enantone LP during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking enantone LP. Enantone LP is pregnancy risk category X, according to the US Food and Drug Administration (FDA).
FDA pregnancy risk category reference below:
- A=No risk
- B=No risk in some studies
- C=There may be some risk
- D=Positive evidence of risk
Contraindicated; not known if drug is excreted in breast milk; make decision to either discontinue nursing or discontinue drug, taking into account risk and benefits to the mother.
What side effects can occur from enantone LP (leuprolide)?
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most common side effects persist or become bothersome:
- Breast tenderness
- Decreased sexual desire or ability
- Difficulty sleeping
- Hot flashes or sweating
- Infection (fever, chills, sore throat)
- Nausea or vomiting
- Pain, redness, or swelling at the injection site
Seek medical attention right away if any of these severe side effects occur:
- Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue)
- Blood in the urine
- Burning, numbness, tingling, or weakness
- Fast, slow, or irregular heartbeat
- Mental or mood changes (e.g., anxiety, delusions, depression, nervousness)
- New or worsening bone pain
- Severe dizziness or light-headedness
- Severe drowsiness
- Severe headache
- Shortness of breath
- Swelling of the hands, ankles, or feet
- Symptoms of heart attack (e.g., chest, jaw, or left arm pain; numbness of an arm or leg; sudden, severe headache or vomiting; vision changes)
- Symptoms of high blood sugar (e.g., drowsiness; fast breathing; flushing; fruit-like breath odor; increased thirst, hunger, or urination)
- Symptoms of stroke (e.g., confusion, one-sided weakness, slurred speech, vision changes)
- Trouble urinating or inability to urinate
- Vision changes
Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.
What drugs may interact with enantone LP (leuprolide)?
Enantone LP may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs, and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.
Products may interact with your drug, including:
- Antiarrhythmic medicines (e.g., amiodarone, quinidine, sotalol), because they may increase the risk of a certain type of irregular heartbeat (prolonged QT interval).
- Bupropion or selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline), because they may increase the risk of seizures.
Does food or alcohol interact with enantone LP (leuprolide)?
Enantone LP may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.
What health conditions may interact with enantone LP (leuprolide)?
Enantone LP may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.
Especially if you have:
- A history of diabetes or high blood sugar
- Urinary problems (e.g., a blockage of the bladder or ureters)
- Spinal cord problems
- Abnormal growths on or near the spinal cord
- Nervous system problems (e.g., tumors)
- A certain type of irregular heartbeat (congenital long QT syndrome) or other heart problems (e.g., congestive heart failure)
- Blood vessel problems (e.g., in the brain)
- A stroke
- Bone problems (e.g., weak bones, osteoporosis)
- Blood electrolyte problems (e.g., low blood magnesium or potassium levels)
The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using enantone LP (leuprolide).
What is the dose of enantone LP (leuprolide) for an adult?
The recommended dose is one 3.75-mg DPS monthly, or one 11.25-mg DPS every 3 months as a single SC/IM inj.
The recommended dose is one 3.75-mg DPS monthly, or one 11.25-mg DPS every 3 month as a single SC/IM inj.
Patient <50 kg
The recommended dose is 1.88-mg DPS monthly. Start during the 1st 5 days of the menstrual cycle. Duration: 6 months, can be used for 12 months w/ concurrent HRT (norethindrone acetate 5 mg daily).
The recommended dose is one 1.88-mg DPS monthly, or 3.75-mg DPS for patients w/ heavy wt or markedly enlarged uterus, for 3 months, or one 11.25-mg DPS as single SC/IM inj.
The recommended dose is one 3.75-mg DPS monthly as a single SC/IM inj.
Central precocious puberty
The recommended dose is 3.75-mg DPS 90-400 mcg/kg SC/IM monthly. Dose adjusted according to patient’s response.
What is the dose of enantone LP (leuprolide) for a child?
Central Precocious Puberty
Indicated when signs of sexual maturity begin to develop in girls <8 years old and boys <9 years old; may be discontinued at appropriate age of onset of puberty (e.g., 11 years in females and 12 years in males), at physician’s discretion.
<2 years old: Safety and efficacy not established.
Lupron Depot-Ped (monthly dose)
- <25 kg: The recommended dose is 7.5 mg IM monthly.
- >25 kg to 37.5 kg: The recommended dose is 11.25 mg IM monthly.
- >37.5 kg: The recommended dose is 15 mg IM monthly.
- Assess response 1-2 months after initial injection; if adequate hormonal and clinical suppression not achieved with starting doses, increase next monthly dose to the next higher level.
Lupron Depot-Ped (3-month dose)
- The recommended dose is 11.25 mg or 30 mg as single IM injection every 3 months (dose not based on weight).
- Regardless of dose chosen, goals are to suppress pituitary gonadotropins and peripheral sex steroids and to arrest progression of secondary sexual characteristics.
- Assess response 2-3 months after initial injection and 6 months after injection.
- The recommended dose is 50 mcg/kg/day SC; may be titrated upward by 10 mcg/kg/day if downregulation not achieved.
How is enantone LP (leuprolide) available?
Enantone LP is available in the following dosage forms and strengths:
- Enantone L.P. powd for inj 1.88 mg
- Enantone L.P. powd for inj 11.25 mg
- Enantone L.P. powd for inj 3.75 mg
What should I do in case of an emergency or overdose?
In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.
What should I do if I miss a dose?
If you miss a dose of enantone LP, contact your doctor right away.
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