Indication

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

Caregivers may be interested in knowing what treatment options are available for prostate cancer, when each option is appropriate, and the benefits and risks associated with each therapy. They may want to assist the patient in taking an active part in making decisions about medical care, and they may want information about how each choice may affect them.

Watchful Waiting

This option involves no medication. Men who choose this alternative need to be monitored regularly by their doctors 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.1 All patients, even those who opt for watchful waiting, may experience sexual dysfunction.2

Radiation Therapy

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.3

Surgery

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.3

Cryotherapy

Cryotherapy uses a metal probe to freeze cancer cells. The probe is placed through a skin incision and guided to the prostate using ultrasound.10 The ultrasonic appearance of the prostate changes as it is frozen, guiding the operation. Cryosurgery 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 (anticancer drugs)

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.1

Hormonal Therapy

Testosterone and other male hormones (called androgens) help prostate cancer cells grow. Hormonal therapy helps suppress prostate cancer cells from getting male hormones. Hormonal therapy is for the palliative treatment of advanced prostate cancer and will not cure cancer.3

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.3

Medical Hormonal Therapy
Estrogens are female hormones. They block the release and activity of testosterone. Their side effects include blood clots and breast enlargement, and for this reason, they have been largely replaced by luteinizing hormone-releasing hormone (LHRH) agonists.4

Antiandrogens block the activity of any androgens in the blood. These drugs are useful because even after an orchiectomy a small amount of androgen may be produced by the adrenal glands.4

LHRH agonists reduce the testicles from producing testosterone. They are administered on a regular schedule (either every month, 3, 4, 6 or 12 months) in the doctor's office.4

Side effects of all hormonal treatments include hot flashes, decreased sex drive, erectile dysfunction, fatigue, decreased muscle mass and strength, osteoporosis, loss of penile/testicular mass, and anemia.1,5 Antiandrogen side effects include, erectile dysfunction, breast enlargement, and liver problems.4 LHRH agonist therapy side effects include hot flashes, sweating, and erectile dysfunction. When LHRH agonists are first started, they may make prostate cancer symptoms worse by initially causing an increase in testosterone levels. This initial burst of testosterone is called a "flare". As testosterone levels fall, the symptoms subside.4

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.

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.


  1. 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.
  2. 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.
  3. National Cancer Institute. Prostate Cancer Treatment. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/prostate/patient Accessed June 1, 2010.
  4. 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.
  5. 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. Accessed June 1, 2010.

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