Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.
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Dr. David Mcleod
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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.

Classically, advanced prostate cancer was defined as prostate cancer with evidence of metastases to bone or soft tissue. That definition expanded to include hormonally resistant prostate cancer, that is, prostate cancer that was treated with hormonal therapy and did not respond. The pendulum has continued to swing: the current definition of advanced prostate cancer includes prostate cancer with metastases and prostate cancer with an increasing prostate-specific antigen (PSA) after definitive therapy.

I seldom see patients who present to me primarily with metastatic prostate cancer. My patients already know they have prostate cancer because they have had their PSA tested by a primary care physician, it was elevated, and this prompted the referral. Some of the patients referred to me have already had a biopsy done elsewhere. As my patients usually have already come to terms with having cancer, our discussions center on the stage of their cancer and the therapeutic options. I try to include caregivers in the discussions, mainly because when the patient leaves they usually have difficulty explaining to their caregivers what happened during the visit, so it's easier for all concerned to include caregivers in the discussion.

I present patients with several therapeutic options, among them luteinizing hormone-releasing hormone (LHRH) agonists. In particular, patients with metastatic disease are candidates for LHRH agonist therapy, as are patients who have had surgery, radiation therapy, or both and have rising PSA levels. However, I don't want the treatment to be worse than the disease, so before starting therapy I consider the level and doubling time of the PSA.

A great deal of how patients accept therapy depends on how the physician presents it, so I try not to overemphasize side effects. I tell them that they may experience hot flashes in the beginning of their therapy because LHRH agonists can cause an initial testosterone flare and rise in PSA. Long-term side effects may include anemia, weight gain, loss of sexual desire, osteoporosis, not feeling well, and testicular atrophy. Nevertheless I encourage them to try LHRH agonist therapy as a first-line therapy because approximately 80% of patients respond to it at least temporarily.

Before any therapy for advanced prostate cancer is started, I get a baseline complete metabolic panel, PSA, alkaline phosphatase for patients with bone metastases, and liver function tests for patients with liver metastases. For some of my patients I order a bone mineral density to screen them for osteoporosis. I primarily monitor my patients' PSA levels, but I also follow their testosterone levels and any other test that was initially abnormal or may help follow the progression of their disease.

I often recommend that my patients consider enrolling in clinical trials. It's not a panacea, but patients who enroll in clinical trials have a good chance of getting trial medication. Even if they don't get the trial drug they get standard therapy. Clinical trials provide a stricter follow-up regimen than is normally provided for patients. In addition, being part of a trial helps the physician-patient bond.

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