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Indication

ELIGARD is a prescription drug, given by injection, for the management of advanced prostate cancer. However, there is no known cure for prostate cancer.
See Full Prescribing Information

For U.S. Residents Only

Important Safety Information for ELIGARD

ELIGARD should not be used by anyone who is allergic to any drug product in the same class of products, or who is allergic to any of the ingredients of Eligard, including leuprolide acetate. Life-threatening allergic reactions have been reported with the drugs in Eligard’s class. Eligard should not be used in women who are pregnant of may become pregnant. ELIGARD can cause pregnancy loss and harm to the fetus when used by a pregnant woman.

Eligard, like other drugs in its class, causes a temporary increase in testosterone during the first and second weeks of treatment. Patients may experience worsening of symptoms or new symptoms during the first weeks of treatment, including bone pain, nerve damage, blood in the urine, pressure on the spine, or difficulty urinating. If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be fatal. You may require close medical attention during the first few weeks of therapy and you should notify your doctor if you develop any new or worsened symptoms after beginning treatment with Eligard.

Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving the drugs in Eligard’s class. Your doctor will monitor your blood sugar levels. Increased risk of heart attack, sudden death due to heart attack, and stroke has also been reported in men with the use of the drugs in Eligard’s class. Your doctor will monitor you for heart disease.

The most common injection site side effects are temporary burning and stinging, pain, bruising and redness. The most common systemic adverse events include mild to severe hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage and breast enlargement. For more information on these and other side effects, please talk to your doctor.

Please see full Prescribing Information.

 

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ELIGARD (leuprolide acetate for injectable suspension) – A Hormonal Therapy for Advanced Prostate Cancer


ELIGARD is a prescription medication for the palliative treatment (management of symptoms) of advanced prostate cancer. ELIGARD is an LHRH (luteinizing hormone-releasing hormone) agonist. It is designed to reduce the amount of testosterone in the body by reducing the testicles' production of testosterone. It is not a cure for advanced prostate cancer.

ELIGARD is available in 4 different prescription doses, with dosing options for treating your advanced prostate cancer. The ELIGARD 45 mg shot, is a 6-month hormone therapy for the treatment of advanced prostate cancer. ELIGARD 45 mg gives you the option of a full year of hormone therapy with 2 injections at 6 month intervals. Ask your doctor if a 6-month dose would be appropriate for you. ELIGARD is also available as a 1 month, 3 month, and 4 month dosing option.

ELIGARD (leuprolide acetate for injectable suspension) Side Effects

ELIGARD decreases the level of male hormones in the body. As a result, ELIGARD may cause side effects. The most common systemic adverse events include mild to severe hot flashes/sweats, fatigue, weakness, fever, muscle pain, testicular shrinkage and breast enlargement. Please see additional safety information below. The most common injection site effects include temporary burning and stinging, pain, bruising, and redness.

Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving the drugs in ELIGARD’s class. Your doctor will monitor your blood sugar levels. Increased risk of heart attack, sudden death due to heart attack, and stroke has also been reported in men with the use of the drugs in ELIGARD’s class. Your doctor will monitor you for heart disease.

It's important that you pay attention to how you're feeling and share that information with your doctor or nurse. They may have suggestions beyond what's on this web site on how to manage the effects.

For more information, see the ELIGARD Prescribing Information or talk to your doctor or nurse.

Most Common Systemic Side Effects of ELIGARD (reported by greater than 2% or more of men) in clinical trials
Dose Side Effects
ELIGARD
7.5 mg
  • Hot flashes/sweats
  • Fatigue
  • Decrease in the size of the testes
  • Dizziness
  • Inflammation of the stomach/intestine
ELIGARD
22.5 mg
  • Hot flashes/sweats
  • Fatigue
  • Nausea
  • Joint Pain
  • Itching
  • Urinary frequency
ELIGARD
30 mg
  • Hot flashes
  • Fatigue
  • Dizziness
  • Clamminess
  • Testicular atrophy (decrease in the size of the testes)
  • Decreased libido
  • Night sweats
  • Gynecomastia (breast growth)
  • Testicular pain
  • Hair loss
  • Frequent need to urinate, especially at night
  • Myalgia (muscle pain)
  • Nausea
ELIGARD
45 mg
  • Hot flashes
  • Fatigue
  • Testicular atrophy (decrease in the size of the testes)
  • Myalgia (muscle pain)
  • Gynecomastia (breast growth)
  • Weakness
  • Night sweats
  • Pain in limb

Other Systemic Side Effects of ELIGARD (reported by fewer than 2% of men)
Body System Adverse Event
General Sweating, insomnia, syncope, rigors, weakness, lethargy
Gastrointestinal Flatulence, constipation, dyspepsia
Hematologic Decreased red blood cell count, hematocrit and hemoglobin
Metabolic Weight gain
Musculoskeletal Tremor, backache, joint pain, muscle atrophy, limb pain
Nervous Disturbance of smell and taste, depression, vertigo
Psychiatric Insomnia, depression, loss of libido*
Renal/Urinary Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia aggravated
Reproductive/Urogenital Testicular soreness/pain, impotence*, decreased libido*, gynecomastia*, breast soreness/tenderness*, testicular atrophy*, erectile dysfunction, penile disorder*, reduced penis size
Skin Alopecia, clamminess, night sweats*, sweating increased*
Vascular Hypertension, hypotension

* Expected pharmacological consequences of testosterone suppression


Important Safety Information

Other adverse events can occur that are not listed in these reports. Report any side effects you may experience to your doctors.

Questions to Ask Your Doctor

  • What side effects am I likely to experience?
  • Can you recommend ways to manage side effects?
  • Are the side effects permanent or temporary?
  • Are there certain foods that might help?
  • What form of exercise is right for me?

Important Safety Information for ELIGARD (leuprolide acetate for injectable suspension)

ELIGARD should not be used by anyone who is allergic to any drug product in the same class of products, or who is allergic to any of the ingredients of Eligard, including leuprolide acetate. Life-threatening allergic reactions have been reported with the drugs in Eligard’s class. Eligard should not be used in women who are pregnant of may become pregnant. ELIGARD can cause pregnancy loss and harm to the fetus when used by a pregnant woman.

Eligard, like other drugs in its class, causes a temporary increase in testosterone during the first and second weeks of treatment. Patients may experience worsening of symptoms or new symptoms during the first weeks of treatment, including bone pain, nerve damage, blood in the urine, pressure on the spine, or difficulty urinating. If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be fatal. You may require close medical attention during the first few weeks of therapy and you should notify your doctor if you develop any new or worsened symptoms after beginning treatment with Eligard.

Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving the drugs in Eligard’s class. Your doctor will monitor your blood sugar levels. Increased risk of heart attack, sudden death due to heart attack, and stroke has also been reported in men with the use of the drugs in Eligard’s class. Your doctor will monitor you for heart disease.

The most common injection site side effects are temporary burning and stinging, pain, bruising and redness. The most common systemic adverse events include mild to severe hot flashes/sweats, fatigue, weakness, muscle pain, dizziness, clamminess, testicular shrinkage and breast enlargement. For more information on these and other side effects, please talk to your doctor.

Indication

ELIGARD is a prescription drug, given by injection, for the management of advanced prostate cancer. However, there is no known cure for prostate cancer.

Please see full Prescribing Information.