Generic name: leuprolide
Brand names: Lupron Depot, Lupron Depot-Ped, Lupron 14-Day Kit
Dosage form: subcutaneous injection, intramuscular injection
Drug classes: Gonadotropin releasing hormones, Hormones / antineoplastics
What is Lupron Depot?
Lupron Depot (leuprolide) is a man-made hormone that overstimulates the body's production of certain hormones, which activates a negative feedback mechanism that, within a few weeks, temporarily reduces the amount of testosterone or estradiol produced by the body.
Lupron Depot may used in men to treat prostate cancer, and some forms may be used to treat female hormone-related problems such as endometriosis and uterine fibroids. Lupron Depot-Ped may be used to treat precocious (early-onset) puberty in both male and female children at least 2 years old. Lupron injection 14-day kit may be used to delay the release of eggs that will be retrieved for in vitro fertilization (IVF).
Lupron Depot may also be used to treat other hormone-related conditions, off-label (off-label means not an FDA-approved use but a recognized use of the medicine).
Lupron Depot-GYN and many other branded leuprolide products are no longer available commercially in the U.S., but generic options are available through several manufacturers.
Initially, leuprolide works by stimulating gonadotropin-releasing hormone (GnRH) receptors, which, at the beginning causes a surge in FSH and LH because GnRH controls the secretion of these hormones. However chronic administration causes a downregulation of these receptors, reducing the release of FSH and LH, and subsequent suppression of ovarian and testicular production of estradiol and testosterone respectively. It belongs to the class of medicines known as gonadotrophin-releasing hormone agonists (GnRH agonists).
Lupron was first FDA-approved in 1985.
Do not use Lupron Depot if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, or nafarelin, or if you have abnormal vaginal bleeding that has not been checked by a doctor.
Your symptoms may become temporarily worse when you first start using Lupron Depot. In adults, this may cause transient worsening of symptoms, including the signs and symptoms of prostate cancer, bone pain, or endometriosis during the first few weeks of treatment. In children, there may be a temporary increase in the clinical signs and symptoms of puberty, including vaginal bleeding. Tell your doctor if any increase in symptoms continues for longer than 2 months.
GnRH analogs may be associated with an increased risk of seizures in people with or without a history of predisposing factors, and in children, there is an increased risk of psychiatric events and mood changes, such as emotional lability (eg, crying, irritability, impatience, anger, and aggression). Call your doctor at once if you have a seizure or unusual changes in mood or behavior.
Pseudotumor Cerebri (high pressure inside the skull) has been reported in children receiving GnRH agonists, including Lupron Depot-Ped. Monitor children for headaches, swelling of the optic nerve, and blurred vision.
The risk of developing diabetes is increased in people receiving GnRH analogs. Your doctor will monitor your blood glucose level and manage any changes according to guidelines.
GnRH analogs are associated with an increased risk of myocardial infarction, sudden cardiac death, and stroke. Your doctor will monitor you for cardiovascular disease, and heart arrhythmias, and manage according to current clinical practice.
Leuprolide can harm an unborn baby or cause birth defects. Do not use it if you are pregnant or breastfeeding.
Before taking this medicine
Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.
To make sure Lupron Depot is safe for you, tell your doctor if you have ever had:
- depression, mental illness, or psychosis
- seizures or epilepsy
- a blood vessel disorder
- a brain tumor or spinal cord injury
- heart disease, congestive heart failure, long QT syndrome
- an electrolyte imbalance (such as low levels of potassium or magnesium in your blood) or
- risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).
Call your doctor if your periods continue while you are being treated with this medicine.
Do not give this medicine to any child without medical advice.
Pregnancy and Breastfeeding
Lupron Depot usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Leuprolide can cause birth defects and should not be used if you are pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy because leuprolide can make hormonal birth control less effective. Tell your doctor right away if you inadvertently become pregnant.
You should not breastfeed while using leuprolide.
Leuprolide may cause infertility, although research shows full reversibility of fertility suppression when leuprolide is discontinued after continuous administration for up to 24 weeks. Lupron may be used to delay egg release for IVF treatment.
How is Lupron administered?
Initially, Lupron Depot must be administered under the supervision of a healthcare provider, although some people can be taught how to self-administer it themselves.
Lupron is given either by injection subcutaneously (under your skin) or into a muscle. The dosing schedule varies depending on the condition being treated
Different brands or strengths of leuprolide are used to treat different conditions. It is very important that you receive exactly the brand and strength your doctor has prescribed. Always check your medication to make sure you have received the correct brand and type prescribed by your doctor.
- Lupron Depot is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider can teach you how to properly use the medication by yourself.
- Lupron Depot-Ped is given into the muscle every 1,3, or 6 months depending on the dosage.
- The 14-day kit is given as a daily subcutaneous injection.
You may need frequent medical tests while using this medicine.
Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets.
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Lupron Depot?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the side effects of Lupron Depot?
Get emergency medical help if you have signs of an allergic reaction to Lupron Depot (such as hives, sweating, fast heartbeats, dizziness, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, a red or purple skin rash that spreads and causes blistering and peeling).
Call your doctor at once if you have:
- A seizure
- A sudden severe headache
- A wheezing, dry cough, or hack
- Bone pain
- Heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
- High blood sugar, symptoms may include increased thirst, increased urination, hunger, dry mouth, or fruity breath odor
- Loss of movement in any part of your body
- Muscle weakness or loss of use, loss of bowel or bladder control
- Pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet
- Painful or difficult urination
- Problems with your eyes or vision
- Rapid weight gain
- Signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech
- Sudden chest pain or discomfort
- Unusual changes in mood or behavior (crying spells, anger, feeling irritable)
Common Lupron side effects affecting more than 2% of patients may include:
- Abdominal pain
- Breast tenderness
- Decreased testicle size
- Decreased interest in sex
- General pain
- Hot flashes
- Increased sweating
- Injection site reactions
- Mood changes
- Nausea and vomiting
- Vaginal bleeding or discharge
- Weight increase.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
What other drugs will affect Lupron Depot?
Leuprolide can cause serious heart problems. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.
Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Store in the original carton at room temperature, away from moisture and heat. Protect from light.
Lupron Depot 7.5mg for 1-month administration. Front chamber: leuprolide acetate (7.5 mg), purified gelatin (1.3 mg), DL-lactic and glycolic acids copolymer (66.2 mg), and D-mannitol (13.2 mg). Back chamber: carboxymethylcellulose sodium (5 mg), D-mannitol (50 mg), polysorbate 80 (1 mg), water for injection, USP, glacial acetic acid, USP to control pH.
Lupron Depot 22.5 mg for 3-month administration. Front chamber: leuprolide acetate (22.5 mg), polylactic acid (198.6 mg), and Dmannitol (38.9 mg). Back chamber: carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
Lupron Depot 30 mg for 4-month administration. Front chamber: leuprolide acetate (30 mg), polylactic acid (264.8 mg), and D-mannitol (51.9 mg). Back chamber: carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
Lupron Depot 45 mg for 6-month administration. Front chamber: leuprolide acetate (45 mg), polylactic acid (169.9 mg), D-mannitol (39.7 mg), and stearic acid (10.1 mg). Back chamber: carboxymethylcellulose sodium (7.5 mg), D-mannitol (75.0 mg), polysorbate 80 (1.5 mg), water for injection, USP, and glacial acetic acid, USP to control pH.
Lupron Depot-PED: 7.5 mg, 11.25 mg or 15 mg for 1-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: purified gelatin, DL-lactic and glycolic acids copolymer, D-mannitol,
carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to
Lupron Depot-PED: 11.25 mg or 30 mg for 3-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water
for injection, USP, and glacial acetic acid, USP to control pH.
Lupron Depot-PED: 45 mg for 6-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, and stearic acid, carboxymethylcellulose sodium, Dmannitol, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.
Active ingredients: leuprolide acetate (5 mg/mL), sodium chloride, USP (6.3 mg/mL) for tonicity adjustment, benzyl alcohol, NF as a preservative (9 mg/mL), and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF, and/or acetic acid, NF.
Supplied as a 14-day kit with 14 disposable syringes and 28 alcohol swabs.
Patients treated with Lupron Depot (leuprolide acetate) for prostate cancer usually continue treatment upon development of castration-resistant prostate cancer, whether it has spread beyond the prostate (metastatic) or not. Continue reading
Lupron Depot (leuprolide acetate) injection is not a chemotherapy treatment, but a prescription hormone medicine used in the palliative treatment of advanced prostate cancer. Palliative treatment is used to relieve pain or other symptoms and improve the quality of your life. Lupron Depot is not a cure for advanced prostate cancer. Continue reading
Before reconstitution, Lupron Depot for treatment of prostate cancer can be stored in its original container at room temperature (77°F [25°C]), with a range between 59°F to 86°F [15°C to 30°C]). Once Lupron Depot is reconstituted, inject the suspension immediately. Discard if not used within two hours, because Lupron Depot does not contain a preservative. Continue reading
Lupron Depot (leuprolide acetate) is a depot suspension formulation only injected by your doctor. Lupron Depot is injected into a muscle of your upper arm, upper thigh or buttocks once every month, or once every 3, 4 or 6 months for the treatment of prostate cancer. Depot formulations release medicine continuously over a certain period of time. Continue reading
In clinical studies evaluating endometriosis, 95% of women started their periods (normal menstrual cycle) in the third month after treatment ended with Lupron Depot 3.75 mg. Continue reading
During an vitro fertilization (IVF) protocol, your doctor may use leuprolide (Lupron) injection as part of an ovarian stimulation regimen. Leuprolide is a gonadotrophin-releasing hormone (GnRH) agonist. It reduces the amount of hormone that stimulates ovulation. This helps to control your ovulatory cycle and prevent premature ovulation, so that your doctor can have predictable access to your eggs for IVF. The brand name Lupron is no longer available in the U.S., but generic options are available. Continue reading
Lupron Depot and Eligard are brand name medicines that both contain the active ingredient leuprolide acetate. Both Lupron Depot and Eligard are prescribed to treat the symptoms of advanced prostate cancer. Lupron Depot is also approved to treat endometriosis, uterine fibroids, or central precocious puberty (CPP) in children (early puberty). Continue reading
Yes, you may still become pregnant if you are using Lupron Depot. Lupron Depot is not a method of birth control. Even though you may not have a period, unprotected intercourse could result in pregnancy. Lupron Depot can cause harm to an unborn child. You should use a reliable non-hormonal birth control such as condoms, a diaphragm with contraceptive jelly, or a copper IUD to prevent pregnancy. Talk to your doctor about use of birth control before you start treatment with Lupron Depot. Continue reading
No, Firmagon (degarelix) is not the same as Lupron but they are both hormone deprivation treatments that may be used for the treatment of advanced prostate cancer. Firmagon takes a more direct path to testosterone suppression than Lupron. Firmagon is an antagonist that immediately stops testosterone production, preventing a testosterone surge and eliminating the need for any additional therapies. Lupron is an agonist that desensitizes the GnRH receptor but causes an initial surge in testosterone and may require additional medication. Continue reading
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