WARNING
Immediate-onset systemic allergic reactions, some resulting in hypotension and syncope, have occurred after administration of Plenaxis®. These immediate-onset reactions have been reported to occur following any administration of Plenaxis®, including after the initial dose. The cumulative risk of such a reaction increases with the duration of treatment (see WARNINGS). Following each injection of Plenaxis®, patients should be observed for at least 30 minutes in the office and in the event of an allergic reaction, managed appropriately.
- Only physicians who have enrolled in the Plenaxis® PLUS Program (Plenaxis® User Safety Program), based on their attestation of qualifications and acceptance of prescribing responsibilities, may prescribe Plenaxis® (See DOSAGE AND ADMINISTRATION and HOW SUPPLIED).
- Plenaxis® is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
- The effectiveness of Plenaxis® in suppressing serum testosterone to castrate levels decreases with continued dosing in some patients (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Effectiveness beyond 12 months has not been established. Treatment failure can be detected by measuring serum total testosterone concentrations just prior to administration on Day 29 and every 8 weeks thereafter (see WARNINGS).
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PLENAXIS SUMMARY
Abarelix for injectable suspension (Plenaxis®) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH).
Plenaxis® is indicated for the palliative treatment of men with advanced symptomatic prostate cancer, in whom LHRH agonist therapy is not appropriate and who refuse surgical castration, and have one or more of the following: (1) risk of neurological compromise due to metastases, (2) ureteral or bladder outlet obstruction due to local encroachment or metastatic disease, or (3) severe bone pain from skeletal metastases persisting on narcotic analgesia.
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NEWS HIGHLIGHTSMedia Articles Related to Plenaxis (Abarelix)
Time Between Treatment And PSA Recurrence Predicts Death From Prostate Cancer
Source: Health News from Medical News Today [2009.11.05]
Men whose prostate specific antigen (PSA) rise within 18 months of radiotherapy are more likely to develop spread and die of their disease, according to an international study led by Fox Chase Cancer Center radiation oncologist Mark K. Buyyounouski, M.D., M.S. and presented at the annual meeting of the American Society for Radiation Oncology (ASTRO).
Men Urged To Seek Advice Due To Faulty Prostate Cancer Home Test Kits
Source: Cancer / Oncology News From Medical News Today [2009.11.05]
Men who have used 'Simplicity Health' or 'Fortel' home testing kits for prostate cancer screening during the past 12 months are being urged to contact their GP for advice. This follows recent notification to the Medicines and Healthcare products Regulatory Agency (MHRA) that the two kits from batch number 1012 are faulty and could give a false negative result. The 1000 defective devices shipped to the UK were sold through pharmacies and via the internet.
Study Of Race, Income And Prostate Cancer Outcome
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.05]
A patient's socioeconomic status (income, marital status and race) has absolutely no impact on his outcome following curative radiation therapy for the treatment of prostate cancer, according to a new study from Henry Ford Hospital in Detroit. "This study offers an extremely important message for all patients with prostate cancer who receive radiation therapy," says Benjamin Movsas, M.D.
Blood Vessels Might Predict Prostate Cancer Behavior
Source: Prostate / Prostate Cancer News From Medical News Today [2009.11.05]
A diagnosis of prostate cancer raises the question for patients and their physicians as to how the tumor will behave. Will it grow quickly and aggressively and require continuous treatment, or slowly, allowing therapy and its risks to be safely delayed? The answer may lie in the size and shape of the blood vessels that are visible within the cancer, according to research led by investigators at The Ohio State University Comprehensive Cancer Center-Arthur G.
Red, processed meats linked to prostate cancer (Reuters)
Source: Y! Health Cancer & Chemotherapy News [2009.11.05]
Reuters - Men who eat a lot of red meat and processed meats may have a higher risk of developing prostate cancer than those who limit such foods, a large study of U.S. men suggests.
Published Studies Related to Plenaxis (Abarelix)
A phase 3, multicenter, open label, randomized study of abarelix versus leuprolide plus daily antiandrogen in men with prostate cancer. [2002.04]
PURPOSE: We compared the endocrinological and biochemical efficacy of abarelix depot, a gonadotropin-releasing hormone antagonist, with that of a widely used combination of luteinizing hormone releasing hormone agonist and a nonsteroidal antiandrogen... CONCLUSIONS: Abarelix as monotherapy achieves medical castration significantly more rapidly than combination therapy and avoids the testosterone surge characteristic of agonist therapy. Both treatments were equally effective in reducing serum prostate specific antigen, and achieving and maintaining castrate levels of testosterone.
A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer. [2001.11]
OBJECTIVES: To evaluate the levels of testosterone and other hormones in men with prostate cancer treated with abarelix versus leuprolide acetate... CONCLUSIONS: Treatment with abarelix produced a higher percentage of patients who avoided a testosterone surge and had a more rapid time to testosterone suppression with a higher rate of medical castration 1 day after treatment and greater reductions in testosterone, luteinizing hormone, follicle-stimulating hormone, and dihydrotestosterone during the first 2 weeks of treatment compared with leuprolide acetate. The achievement and maintenance of castration was comparable between the two groups.
Abarelix for injectable suspension: first-in-class gonadotropin-releasing hormone antagonist for prostate cancer. [2006.12]
Abarelix, a gonadotropin-releasing hormone antagonist, with its indication for advanced symptomatic prostate cancer, represents the newest category of hormonal therapy introduced in the past 15 years. Results from Phase II and III clinical trials demonstrate the advantages of abarelix over commonly used luteinizing hormone-releasing hormone (LHRH) agonist therapy: abarelix does not cause a surge in serum testosterone that can precipitate a flare phenomenon or worsening of disease, particularly dangerous for patients with metastatic, symptomatic disease, and produces medical castration more quickly...
Dose-escalated abarelix in androgen-independent prostate cancer: a phase I study. [2006.10]
Follicle-stimulating hormone has been shown to be a mitogen in preclinical models of androgen-independent prostate cancer and abarelix has been previously shown to significantly reduce follicle-stimulating hormone levels in patients when administered monthly... Treatment with biweekly abarelix in patients with androgen-independent prostate cancer is feasible with no unexpected toxicity, but fails to completely suppress serum follicle-stimulating hormone levels or produce prostate-specific antigen responses.
Abarelix: the first gonadotrophin-releasing hormone antagonist for the treatment of prostate cancer. [2004.10]
The high incidence of prostate cancer makes it a major healthcare problem and the second leading cancer-related cause of death among men in developed countries.The place of GnRH antagonists in the treatment modalities of prostate cancer will then be discussed.
Clinical Trials Related to Plenaxis (Abarelix)
The Plenaxis® Experience Study [Suspended]
Praecis is currently conducting a 2000 patient Experience Study; this is a Phase IV
commitment postmarketing safety study in the Food and Drug Administration (FDA) indicated
population of patients receiving Plenaxis®. The purpose of the study is to estimate the
incidence of immediate-onset systemic allergic reactions in the indicated population
receiving Plenaxis® and to determine whether the hazard rate changes over time.
Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy [Completed]
This is a Phase 2, open-label study in subjects with androgen-independent prostate cancer who
have progressed following treatment with an LHRH agonist. Up to 22 subjects will be
enrolled. Enrollment will be monitored to ensure that not all subjects are enrolled based on
rising prostate specific antigen (PSA) criterion only.
Subjects will be treated with abarelix (Plenaxis) 100 mg intramuscularly (IM) every 2 weeks
for 12 weeks (total dose of 600 mg).
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Page last updated: 2009-11-05
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