Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.
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 Questions your patient may ask
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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.

Your patients may have a variety of questions about prostate cancer. Here are 15 commonly asked questions with replies presented in simple language that you may find helpful when discussing these issues with your patients.

1. What is prostate cancer?

The prostate is a small gland found only in men. It lies just underneath the bladder. It 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

2. How do I know if I am at risk for prostate cancer?

ELIGARD background image Some of the risk factors for prostate cancer include a man's age, his family history, and his race. Prostate cancer is found more frequently in men over age 50 years. Men whose father or brother had prostate cancer are at higher risk. Prostate cancer is more common in African Americans than in Caucasians or Asian men.

3. What are the symptoms of prostate cancer?

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

4. What tests are used to diagnose prostate cancer?

There are three tests commonly used to diagnose prostate cancer. These tests are also used to monitor the status of prostate cancer once it has been diagnosed.

Digital Rectal Examination or DRE
In this examination, the doctor inserts a lubricated, gloved finger into the rectum and feels the size, shape, and surface of the prostate. The prostate gland is located directly in front of the rectum. Cancers that begin in the back of the prostate can often be felt on rectal examination. DRE is also used to help determine if the prostate cancer has returned after treatment or has spread beyond the prostate gland.2

Prostate-specific Antigen or PSA Test
This test measures the level of PSA in the blood. PSA is specific to the prostate but not to cancer and can be elevated in a number of other conditions including prostatitis (inflammation of the prostate) and benign prostatic hyperplasia. PSA is most effective for the detection of prostate cancer when combined with DRE.1

Some medicines and herbal preparations not meant to treat prostate cancer can affect blood PSA.1 At each visit tell your doctor about all prescription and over-the-counter medicines as well as any herbal preparations you are taking.

Transrectal Ultrasound or TRUS
A transrectal ultrasound uses sound waves to evaluate the prostate. A small probe is inserted into the rectum and sound waves are bounced off the prostate to create echoes that the probe registers. The probe is connected to a computer that converts the pattern of the echoes into a picture of the prostate. The amount of information that the doctor can get from this test depends on the size, grade, and location. TRUS is commonly used to guide the needle during a prostate biopsy.2

5. What is the difference between grading and staging prostate cancer?

ELIGARD background image 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®* scan (capromab pendetide). 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 The doctor may describe this stage as I - IV.

6. What are the treatment options for prostate cancer?

Watchful Waiting
This option involves no medication. Men who choose this alternative need to be monitored regularly by their doctor and report any new symptoms immediately. Watchful waiting is usually recommended for older men or men with serious conditions who may not be candidates for aggressive therapy. It is also used in men who have localized slow-growing prostate cancer. Watchful waiting avoids the possible side effects of radiation, surgery, or medications, but the cancer may spread.2 All patients, even those who opt for watchful waiting, may experience sexual dysfunction.3

Radiation Therapy for Prostate Cancer
This treatment choice involves the use of high-energy X-rays to kill cancer cells. The X-rays can come either from a machine or from radioactive seeds implanted in the prostate. Radiation from a machine, called external beam radiation, can cause a variety of problems including diarrhea, inflammation of the rectum or bladder, and urinary difficulties. Internal radiation, or brachytherapy, may result in some discomfort after the seeds are placed, and rarely, to erectile dysfunction.4

Surgery for Prostate Cancer
A radical prostatectomy completely removes the prostate and the tissue that surrounds it. Possible side effects include being unable to control urination or bowel function, and erectile dysfunction.4

Cryotherapy for Prostate Cancer
Cryotherapy uses a metal probe to freeze cancer cells. The probe is placed through a skin incision and guided to the prostate using ultrasound. The ultrasonic appearance of the prostate changes as it is frozen, guiding the operation. Cryosurgery for prostate cancer is less invasive than radical prostatectomy, but long-term outcomes are unknown. Side effects of cryotherapy may include erectile dysfunction and problems with urination and bowel function.2

Chemotherapy for Prostate Cancer
Chemotherapy is the use of anticancer drugs either injected or given orally. Chemotherapy is used for prostate cancer that has metastasized or is not responsive to hormonal therapy. Side effects of chemotherapy depend on the regimen used, the dose, and the length of treatment. Side effects may include nausea and vomiting, loss of appetite, loss of hair, mouth sores, low blood cell count, and blood clots.2

Hormonal Therapy for Prostate Cancer
This therapy reduces prostate cancer cells from getting male hormones. Hormonal therapy can be either medical or surgical.4 Hormonal therapy is for the palliative treatment of advanced prostate cancer.

7. What are the different kinds of hormonal therapy for the palliative treatment of advanced prostate cancer?

Hormonal therapy can be either surgical or medical.4

Surgical Hormonal Therapy
The hormonal therapy first used to treat advanced prostate cancer was surgery to remove the testicles. This procedure is called an orchiectomy or surgical castration. The testicles are the main source of male hormones (androgens) and removing the testes causes most prostate cancers to shrink.4

Medical Hormonal Therapy
Antiandrogens block the activity of any androgens in the blood. Luteinizing hormone-releasing hormone (LHRH) agonists reduce the testicles from producing testosterone.2

8. What is ELIGARD® (leuprolide acetate for injectable suspension)?

ELIGARD is an LHRH agonist that is indicated for the palliative treatment of advanced prostate cancer. It is designed to reduce the amount of testosterone produced by the testicles, thus decreasing the amount of testosterone in the blood.6

9. What are possible side effects of ELIGARD?

Side effects of ELIGARD may include hot flashes, decreased sex drive, erectile dysfunction, fatigue, decreased muscle mass and strength, weight gain, osteoporosis, and anemia. Patients should be provided detailed information, including a package insert for ELIGARD.

Elevated blood sugar and an increased risk of developing diabetes have been reported in men receiving the drugs in ELIGARD’s class. Patients taking ELIGARD should have their blood sugar levels monitored by their doctor. 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. Patients taking ELIGARD should be monitored for heart disease by their doctor.

For additional Safety Information; speak to your doctor.

10. What is ELIGARD used for?

ELIGARD reduces testosterone and maintains testosterone suppression to the level found with surgical castration. ELIGARD is the only LHRH agonist to offer 1-, 3-, 4-, and 6-month dosing options.

11. Is ELIGARD effective?

In studies with ELIGARD, a number of patients experienced testosterone breakthrough once castrate levels were achieved. Testosterone will rise after the first injection, before falling to castrate levels.6

In clinical trials of ELIGARD, most patients with elevated PSA values at the beginning of treatment with ELIGARD had reductions in PSA by the end of the clinical study.

12. What is the delivery system for ELIGARD?

The ELIGARD administration system uses a 18 or 20 guage needle to inject the medication under the skin. ELIGARD and the ATRIGEL® polymer form a small pellet that delivers ELIGARD continuously over time. This pellet biodegrades slowly and steadily, leading to a consistent, level of ELIGARD.6

13. What other things can I do to feel better while on prostate cancer treatment?

There are some lifestyle changes that may help you feel better. These include7:

Eat healthy foods - a healthy diet may help maintain muscle and fat mass, boost strength and energy levels, and decrease the risk of infection and weight gain.

Keep physically active - this may help fight decreased muscle mass, increased fat mass, and loss of bone density. Exercise may also boost energy, relieve stress, and decrease depression.

Manage stress - stress can sap energy and lead to feelings of anxiety, depression, or anger.

14. I am concerned about pain. How can this be managed?

Pain can be managed by a number of effective pain medications, including opioids. Addiction or dependence on opioids is rarely a problem for cancer patients if the drug is being used as directed. Bone pain from metastases can be managed in several ways. Bisphosphonates are a class of drugs that can relieve this pain. Steroids may also give relief. Radiation to bone metastases can also relieve bone pain.2 The best source of information is from your doctor.

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. 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: http://www.cancer.org/docroot/CRI/CRI_2_3x.asp?dt=36. Accessed June 1, 2010.
  3. Steineck G, Helgesen F, Adolfsson J, et al. Quality of life after radical prostatectomy or watchful waiting. N Engl J Med. 2002;347(11):790-796.
  4. National Cancer Institute. Prostate Cancer Treatment. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient Accessed June 1, 2010.
  5. Schroder FH. In: Walsh PC, Retik AB, Vaughan ED, et al, eds. Campbell's Urology. 8th ed. New York, NY: Elsevier Science; 2002:3182-3208.
  6. Perez-Marrero R, Tyler RC. A subcutaneous delivery system for the extended release of leuprolide acetate for the treatment of prostate cancer. Expert Opin Pharmacother. 2004;5(22):447-457. Review.
  7. Sanofi-Synthelabo Inc. A Guidebook for Men With Advanced Prostate Cancer. New York, NY: Sanofi-Synthelabo Inc.; 2002.

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US.LEU.11.10.004 Last Update: October 2011