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.

More information on prostate cancer is available from a variety of sources. The following medical organizations offer informational articles for health-care professionals. Many of these sites also offer further resources for patients. Sanofi-aventis is not responsible for the content of non-sanofi-aventis Web sites.

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.

American Society of Clinical Oncology (ASCO)

http://www.asco.org
The American Society of Clinical Oncology (ASCO) is a professional organization representing physicians who treat people with cancer. ASCO’s mission is to improve cancer care and prevention, educate health-care professionals, support cancer research, and advocate for public policy that benefits people with cancer. The Web site provides information on educational activities for physicians, advocacy initiatives, publications, and practice guidelines issued by ASCO, and career resources.

American Urological Association

http://www.auanet.org/
The AUA is an educational nonprofit organization that provides a wide range of services for its members, including continuing medical education, the Annual Meeting, publications, and health policy advocacy. It has a separate site for patient education, http://www.urologyhealth.org/.

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.

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