Indication

ELIGARD is indicated for the palliative treatment of advanced 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.

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American Cancer Society
http://www.cancer.org/

The American Cancer Society (ACS) is a community-based voluntary health organization with more than 3,400 offices across the United States. Its Web site offers authoritative information on prostate cancer, including an overview of basic biology, treatment options, and statistics for patients and information about research opportunities and funding for professionals.

Cancer Care
http://www.cancercare.org
Cancer Care is a nonprofit agency that offers free professional services to people with cancer and their loved ones. Services include counseling, education, assistance with finding resources, and financial assistance.

National Cancer Institute Prostate Cancer Home Page
http://www.cancer.gov/cancer_information/cancer_type/prostate/
The National Cancer Institute Web site’s section on prostate cancer offers information for both patients and health-care professionals. Topics covered include treatment, prevention, genetics and causes, screening and testing, clinical trials, cancer literature, research, and statistics.

National Prostate Cancer Coalition
http://www.4npcc.org
The National Prostate Cancer Coalition is involved in prostate cancer awareness, advocacy, and outreach. They provide education about prostate cancer diagnosis and treatment, advocate for spending on prostate cancer research, and fund a mobile screening clinic for prostate cancer.

Prostate Cancer Education Council
http://www.pcaw.com
The mission of the Prostate Cancer Education Council is to offer free or low- cost prostate cancer screenings across the nation and to educate the public and medical professionals about the prevalence of prostate cancer, the importance of early detection, and available treatment options. The Web site offers articles, information about upcoming events, awareness campaigns, and information on how to find a low-cost or free screening site.

Prostate Cancer Foundation
http://www.prostatecancerfoundation.org
The Prostate Cancer Foundation is a philanthropic organization that funds prostate cancer research. This site provides detailed information about prostate cancer, publications, an online support group, events to raise money for research, information on clinical trial participation, and results of recent research.

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.


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US.LEU.11.10.004 Last Update: October 2011