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.
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IMPORTANT SAFETY IMFORMATION 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.

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Prostate Cancer Questions and Answers With Dr. Manyak

Dr. Manyak, MD, is a board-certified specialist in urology. Here, he answers your questions about prostate cancer treatment, side effects and ELIGARD.

Dr. Manyak

How does hormonal therapy for management of advanced prostate cancer work?

Testosterone, the primary male hormone, is produced mainly in the testicles and usually aids the growth of prostate cancer cells. There are different types of hormonal therapy—LHRH (luteinizing hormone-releasing hormone) agonists and antiandrogens. Orchiectomy, in which the testicles are surgically removed, is considered surgical hormonal prostate cancer therapy.

I would like to know more about LHRH agonists. How do they work?

LHRH (luteinizing hormone-releasing hormone) agonists are frequently used hormonal therapies. These drugs were developed to offer patients a nonsurgical alternative to removal of the testicles. LHRH agonists are similar to a naturally occurring hormone in the body that normally stimulates the production of testosterone. Changing the pattern of LHRH release reduces the hormone production.

How do the various types of LHRH agonist therapies differ?

Most LHRH (luteinizing hormone-releasing hormone) agonists differ in how they are given to the patient.

For instance, the administration of the drug and needle size vary with each product. The volume (or amount) of the drug that gets injected differs from product to product and may affect how the injection feels. The method of the administration varies with each product, too. Some of the drugs are injected once every 1, 3, 4 or 6 months, and others are surgically implanted annually.


Is it true that testosterone levels actually go up when you first start using an LHRH agonist?

Yes, injections of LHRH agonists stimulate a short surge of testosterone for about 2 weeks. The body reads this as being too much testosterone and essentially shuts down the hormone production. As a result, testosterone levels fall.

What is ELIGARD?

ELIGARD is an LHRH (luteinizing hormone-releasing hormone) agonist. It contains leuprolide acetate, a widely prescribed hormonal therapy for the palliative treatment (management of symptoms) of advanced prostate cancer. Leuprolide acetate limits the signal that tells the testicles to produce testosterone.

How is ELIGARD administered?


What are the benefits of using ELIGARD?

In clinical studies, patients on ELIGARD experienced reduced testosterone levels and reduced serum prostate-specific antigen (PSA) levels for those that started with elevated PSA levels. ELIGARD is available in 1, 3, 4 and 6-month formulations giving you the option that may be right for you. ELIGARD is administered under the skin with a small needle as a liquid and once solidified releases medication uniformly throughout the treatment period.

Does hormonal prostate cancer therapy eliminate a man's sex drive?

Testosterone is responsible for much of the male sex drive, called libido. Testosterone also plays an important role in the ability to get an erection. When testosterone is eliminated from the body, it is common for men to lose their sex drive and their ability to achieve or maintain an erection. However, this doesn't happen to everyone.

I hear hot flashes are a common side effect of ELIGARD. What causes hot flashes?

It's not really understood how reducing testosterone brings on hot flashes. However, it's true that hot flashes are a common side effect of ELIGARD therapy. Hot flashes can range from annoying to debilitating. Sometimes hot flashes are associated with facial flushing, redness, and increased sweating and may cause nausea or interruption of sleep. Hot flashes can be brought on by stress or heat, or they may occur for no apparent reason at all. Studies have shown that the majority of the hot flashes that men experience as a side effect of ELIGARD therapy are typically mild to moderate. Severe hot flashes/sweats were seen in 1% and 3% of patients in the 7.5mg and 30mg studies, respectively.

What does my diet have to do with prostate cancer?

A healthy, balanced diet can do many things for you. In addition to boosting your overall health and well-being, a healthy diet can:
  • Fight 3 possible side effects of hormone therapy—decreased muscle mass, increased fat mass, and weight gain
  • Enhance your strength and energy level
  • Increase the body's ability to tolerate side effects
  • Decrease risk of infection
  • Increase your ability to heal and recover quickly

What is a healthy diet?

A healthy diet means eating a variety of foods that provide the nutrients you need to maintain your health. These nutrients include protein, carbohydrates, fat, water, vitamins, and minerals. Watch the fat, though, since studies suggest that beef, dairy, and other high-fat products may stimulate prostate cancer to grow.

A healthy diet also is important since 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.


About Dr. Manyak

Michael J. Manyak, MD, is a paid consultant for sanofi-aventis U.S. A board-certified specialist in urology, Dr. Manyak is Professor of Urology and Microbiology and Tropical Medicine at George Washington University Medical School in Washington, DC, and Interim Chairman of the Department of Urology at George Washington University Medical Center.

Dr. Manyak served as a urologic consultant for 9 years to the Medical Therapy of Prostate Symptoms (MTOPS) multicenter study on prostate cancer and benign prostatic hyperplasia (BPH), sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases. Currently, he serves as a consultant to the US Food and Drug Administration Panel on Gastrointestinal and Genitourinary Devices. A fellow of the American College of Surgeons, his memberships include the American Association of Clinical Urologists, American Society for Laser Medicine and Surgery, Society for Urologic Oncology, and the Society for Urology and Engineering.

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