Indication

ELIGARD is indicated for the palliative treatment of advanced prostate cancer.
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Dr.Franklin Lowe
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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.

Dr. lowe portraitClassically, prostate cancer has been considered advanced when there are signs of distant spread to either lymph nodes or bone. More recently we have become aware that locally extensive disease, that is, disease outside the prostate including disease involving the seminal vesicles, is advanced disease. In addition, patients who have rising prostate-specific antigen (PSA) after local therapy are considered to have advanced prostate cancer.

In discussing advanced prostate cancer with my patients and their caregivers, I tell them that the implications of advanced prostate cancer, including what therapy would be appropriate, depend on a number of factors. These include the patient's age, any comorbidities, how aggressive their cancer is as determined by their initial Gleason score, and the previous therapy they have had. I work with my patients to use these parameters to develop a therapeutic plan.

I discuss the major side effects of each therapy I offer them. For cryosurgery I discuss fistulae, incontinence, and urgency. For hormonal therapy I mention hot flashes, weight gain, and osteoporosis. If I am offering them chemotherapy, I talk about the standard side effects of nausea, vomiting, and malaise.

After starting my patients on therapy, I monitor their PSA levels, testosterone levels, and alkaline phosphatase levels. For patients on an LHRH agonist, I follow bone mineral density tests. Patients who are given an antiandrogen have their liver function tests monitored.

If the patient's physical, mental, and disease status warrants it, I may suggest a clinical trial, however, clinical trials are not for everyone. If the patient desires to be part of a trial, I will help him enroll.

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