Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.
See Full Prescribing Information
For U.S. Healthcare Professionals Only
Dr. Brian Stone
Skip Navigation Links > Home > Professional Perspectives > Dr. Stone
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.

Dr. Stone portrait Prostate-specific antigen (PSA) testing has become easily available and widely used, and more men are getting tested. For those with elevated PSAs, the diagnosis of prostate cancer is almost uniformly made when the cancer is in the early stages. The overwhelming majority of my new patients have early- stage prostate cancer. Nevertheless, I do on occasion see a patient who presents initially with metastatic disease. I should mention here that my practice is composed predominantly of African American men.

Most of my patients with advanced disease had their localized prostate cancer definitively treated with a radical prostatectomy or radiation therapy and have experienced treatment failure as evidenced by rising PSA values (over a nadir of <0.1 ng/mL); this rise in PSA may be significant. On occasion I make the diagnosis of advanced disease in other ways, such as finding a palpable prostate nodule or disease that palpably extends beyond the capsule of the prostate.

Informing patients that their prostate cancer has progressed is best approached with sensitivity and compassion, as many men find this diagnosis devastating. In my practice, this discussion often takes more than one visit. I try to keep the discussion at about a high school level to help them grasp the concepts. I give them reading materials about advanced prostate cancer to take with them. They frequently don't hear everything I tell them at this visit because they are so upset. I bring them back to talk about the fact that their prostate cancer is advanced. My experience is that patients who have already had the diagnosis of localized prostate cancer and need to be told it has advanced have a much better understanding of the disease and its treatment and are more accepting of their diagnosis than those who are primarily diagnosed with advanced prostate cancer. I ask caregivers to join these discussions. Caregivers often are the ones who take notes and ask questions. Male patients tend to try to handle things on their own and it's important to have their support system be aware of their needs. In addition, as the disease progresses and patients become disabled, the caregivers become the caretakers. They need to be involved in treatment decisions because the burden of care eventually falls on them.

I encourage my patients to have other support systems as well. I recommend that they join a survivors group. For my patient population in New York City, I recommend “Brother to Brother”. I feel strongly that urologists should be aware of the support groups in their area and direct their patients to them.

The therapeutic options that I recommend for advanced prostate cancer depend on the type of disease. I might suggest that they first undergo pelvic lymph node dissection to clarify the stage of the cancer. Therapies I might suggest include cryoablation surgery, radiation therapy, or hormonal therapy, depending on the stage of the disease and other aspects of the patient's situation.

For patients who are candidates for hormonal therapy, I describe the usefulness of luteinizing hormone-releasing hormone (LHRH) agonists as well as the side effects. I talk with them about the sexual side effects, hot flashes, gynecomastia, weight gain, and hair loss. The side effects that seem to be the most bothersome to my patients are gynecomastia, hot flashes, central obesity, and fatigue. While patients are on treatment, I monitor PSA. If the patient has bone metastases, I monitor his alkaline phosphatase levels as well.

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.


© 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