Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.
See Full Prescribing Information
For U.S. Healthcare Professionals Only
About prostate cancer
Skip Navigation Links > Home > Helping Caregivers Understand > About Prostate Cancer
IMPORTANT SAFETY IMFORMATION FOR ELIGARD

Eligard is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists analogs, or any of the components of Eligard. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Eligard is also contraindication in women who are pregnant or may become pregnant. Expected hormonal changes that occur with Eligard treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman.

Eligard, like other GnRH agonists, causes a transient increase in serum testosterone during the first and second weeks of treatment. Patients may experience worsening of symptoms or onset of new symptoms during the first weeks of treatment, including bone pain, neuropathy, hematuria, spinal compression, or bladder outlet obstruction. Cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using GnRH agonists.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia.

Click here for full Prescribing Information and full mixing and administration instructions.

Caregivers of patients may not know the location and function of the prostate gland. They may ask about the symptoms of prostate cancer and how it is diagnosed. They may have little understanding of how prostate cancer is graded and staged and how that information impacts the outlook for survival. They may wonder how prevalent prostate cancer is and who else in the family is at risk. You may find the following set of questions and simple replies useful when speaking with caregivers.

What is prostate cancer?

The prostate is a gland found only in men. It is a small gland located just underneath the bladder and is wrapped around the tube that carries urine from the bladder (the urethra). The prostate makes fluid for semen. Prostate cancer occurs when prostate cells become abnormal and grow in an uncontrolled fashion. Prostate cancer cells do not die after a set amount of time, as other cells do, but instead keep dividing and forming new abnormal cells. Metastasis means that the cancer cells have invaded other parts of the body.1

What are the symptoms of prostate cancer?

Early prostate cancer is rarely symptomatic. Symptoms that may be associated with prostate cancer may include1:

  • Frequent need to urinate, especially at night
  • Difficulty urinating or holding back urine
  • Weak or interrupted flow of urine
  • Pain and burning during urination
  • Difficulty in achieving an erection
  • Painful ejaculation
  • Blood in the urine or semen
  • Frequent pain or stiffness in the low back, hips, or upper thighs

These symptoms are often associated with other benign prostate conditions.1

How is prostate cancer diagnosed?

Simple screening tests for prostate cancer are the digital rectal examination (DRE) and a blood test for prostate-specific antigen (PSA). During a DRE, the doctor puts a lubricated, gloved finger into the rectum; the prostate can be felt through the front wall of the rectum. The doctor checks for hard or lumpy areas or increased gland size.2 PSA is a substance made by prostate cells. PSA levels in the blood may rise for a number of reasons including prostate cancer, benign prostatic hypertrophy, and prostate infection.1

If either of these screening tests is positive, the doctor may perform other, more specific, tests. These tests include a transrectal ultrasound (TRUS) and a biopsy. During a TRUS, a small probe placed in the rectum bounces sound waves against the prostate; the returning echoes are picked up by the probe and used to create an image of the prostate. A biopsy is a procedure to remove a very small amount of the prostate so that it can be examined under a microscope. Usually the doctor will use a TRUS for guidance, numb the area, and quickly insert a very fine needle into the prostate and then remove some tissue. The needle will contain a small cylinder of tissue that can be sent to the laboratory for examination. The doctor usually takes multiple samples, a minimum of 6 to 13, to make sure that the area of cancer is not missed.2

What does the grade and stage of prostate cancer mean?

The grading system for prostate cancer labels the cancer cells by how abnormal they look under a microscope and how likely they are to grow and spread. Grading is used to predict how aggressive the cancer is. Prostate cancer cells are graded according to the Gleason system. This system uses numbers from 1 to 5, based on how much the arrangement of the cells in the tissue looks like normal prostate tissue. A grade is assigned to each of the two largest areas of cancer in the tissue samples. The two grades are added together to create the Gleason Score. Gleason Scores of 2 to 4 are considered low, 5 to 7 are intermediate, and 8 to 10 are high.1

The staging of prostate cancer involves performing tests to discover whether the cancer has spread outside of the original site. Staging is used to decide how advanced the cancer may be. The results of a DRE, PSA level, the TRUS, the biopsy, and the Gleason score are used to decide if staging tests are needed. Tests that may be used to stage prostate cancer include some radiological tests, including CT scan, MRI, bone scan, and ProstaScint®4* scan (capromab pendetide).2 Surgical tests include lymph node biopsy and laparoscopy.1

The stage of a cancer is described by the extent of the original tumor
(T category), whether the tumor has spread to nodes (N category), and whether or not there are distant metastases (M category). The TNM categories and the Gleason grading score are used to decide the stage grouping.1,2

How common is prostate cancer?

Prostate cancer is the second most common cancer in men in the United States (US). One in six men will be diagnosed with prostate cancer during their lifetime, but only one man in 32 will die of it. Prostate cancer is the second leading cause of cancer death (not all death) in men in the US. Nevertheless, in men diagnosed with early prostate cancer, nearly 100% survive at least 5 years, 91% survive at least 10 years, and 76% survive at least 15 years. For men whose prostate cancer has already spread through the body when it is found, the 5-year survival rate is 34%.2

Who else in our family is at risk?

Prostate cancer appears to run in families; having a father or brother with this disease doubles the probability that a man will develop it himself. The risk is higher for men with several affected relatives, especially if those relatives were young at the time of diagnosis.2

A number of other factors influence risk for prostate cancer as well. The chance of having prostate cancer increases quickly after a man is 50 years old. Prostate cancer occurs 70% more often in African American men than in Caucasian men. Diet may influence the likelihood of having prostate cancer. A diet composed of a lot of red meat or high-fat dairy products may increase the risk of prostate cancer.2

Important Safety Information for ELIGARD

Eligard is contraindicated in patients with hypersensitivity to GnRH, GnRH agonists analogs, or any of the components of Eligard. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Eligard is also contraindication in women who are pregnant or may become pregnant. Expected hormonal changes that occur with Eligard treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman.

Eligard, like other GnRH agonists, causes a transient increase in serum testosterone during the first and second weeks of treatment. Patients may experience worsening of symptoms or onset of new symptoms during the first weeks of treatment, including bone pain, neuropathy, hematuria, spinal compression, or bladder outlet obstruction. Cases of ureteral obstruction and/or spinal cord compression, which may contribute to paralysis with or without fatal complications, have been observed in the palliative treatment of advanced prostate cancer using GnRH agonists.

Hyperglycemia and an increased risk of developing diabetes have been reported in men receiving GnRH analogs. Monitor blood glucose level and manage according to current clinical practice. Increased risk of myocardial infarction, sudden cardiac death and stroke has also been reported with use of GnRH analogs in men. Monitor for cardiovascular disease and manage according to current clinical practice.

The most common injection site adverse events are transient burning and stinging, pain, bruising, and erythema. The most common systemic adverse events include mild to severe hot flashes/sweats, malaise and fatigue, weakness, myalgia, dizziness, clamminess, testicular atrophy, and gynecomastia.

Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.

Please see full Prescribing Information and full mixing and administration instructions.


*ProstaScint is a registered trademark of Cytogen Corporation.

  1. Prostate Cancer Foundation. Understanding Prostate Cancer. Available at: http://www.pcf.org/site/c.leJRIROrEpH/b.5779493/k.3D2F/Understanding_Prostate_Cancer.htm. Accessed June 1, 2010.
  2. American Cancer Society. Detailed guide: prostate cancer. Available at: Available at: http://www.cancer.org/docroot/CRI/CRI_2_3x.asp?dt=36. Accessed June 1, 2010. Accessed June 1, 2010.

© 2002-2010 sanofi-aventis U.S. LLC. All rights reserved. Legal Disclaimer Information and Privacy Policy
Questions or Comments? Click here to contact us. This site intended for use by US residents.
US.LEU.11.10.004 Last Update: October 2011