Generic Name: Leuprolide (LOO-proe-lide)
Trade Name: Eligard®, Lupron®, Lupron Depot®, Viadur®
How is this drug used? Leuprolide is FDA approved for the treatment of advanced prostate cancer. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Leuprolide is classified as a luteinizing hormone releasing hormone (LHRH) agonist. LHRH is a naturally occurring hormone in the body that is involved in stimulating the production of female and male hormones such as estrogen and testosterone. Leuprolide inhibits the signaling of LHRH so that the production of estrogen or testosterone is reduced. Certain cancers, such as prostate cancer, are stimulated to grow from hormones. The reduction in the production of growth-stimulatory hormones inhibits the growth of cancer cells.
How is leuprolide given (administered)? Leuprolide is administered as an injection under the skin (subcutaneous), into a muscle (intramuscular), or as an implantable device and the dose depends on several factors, including the condition being treated, the particular regimen being used and the overall health of the patient.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with leuprolide. Blood may be drawn to check hormone levels. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
Patients will also be monitored for a phenomenon called “flare” in which hormone levels may surge during initial therapy with leuprolide. The elevated levels of hormones can cause a sudden increase in symptoms, such as bone pain in patients with cancer spread to the bone, or the obstruction of the urinary system resulting in difficulty or the inability to urinate in patients with prostate cancer. Patients experiencing increased bone pain, particularly in the spine, difficulty in urinating, blood in the urine, or numbness of the hands or feet should consult their healthcare provider immediately.
Patients will also have their heart function monitored, as leuprolide uncommonly causes serious side effects to the heart. In addition, patients will be monitored for blood clots, as this is another uncommon yet serious condition caused by leuprolide. If patients experience pain, redness and/or swelling of one extremity and not the other, difficulty breathing, chest pain, or noticeable changes in heart rate or rhythm, they should contact their healthcare provider immediately. Patients may also be monitored for bone density, as long-term use of leuprolide may decrease the density of bones.
What are the common (occur in 30% or more of patients) side effects of treatment with leuprolide?
• Hot flashes
• Reduced sex drive
• Erectile dysfunction
What are the less common (occur in 10% to 29% of patients) side effects of treatment with leuprolide?
• Breast enlargement, tenderness or pain
• Increased cholesterol levels
• Fluid retention – swelling of the feet or ankles
• Generalized weakness or fatigue
• Increased bone pain – due to “flare” if patients have cancer spread to the bone
• Inability or difficulty in urinating – due to “flare”
• Injection site reactions
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What are the possible late side effects of treatment with leuprolide? One uncommon, yet serious side effect that is associated with treatment with leuprolide is damage to the heart. Patients who experience chest pain, difficulty breathing or noticeable changes in heart rate or rhythm should contact their healthcare provider. Treatment with leoprolide may also lead to decreased bone mineral density, which increases the risk of fractures. Patients should talk with their doctor about their risk of developing late side effects carefully weight the benefits of treatment with these risks.
What can patients do to help alleviate or prevent discomfort and side effects?
• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Maintain adequate rest and nutrition.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
Are there any special precautions patients should be aware of before starting treatment?
• Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
• Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
• Difficulty breathing
• Pain in the chest
• Change in heart rate or rhythm
• Numbness or tingling of hands or feet
• Inability or difficulty to urinate
• Severe depression
• Memory impairment or confusion
• Extreme fatigue
• Leg weakness
• Swelling of feet or ankles
• Sudden weight gain
• Bone pain in lower back or pelvis
What is a package insert?
A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug.
Important Limitations of Use
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