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).
|
|
| |
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.
|
|
NEWS HIGHLIGHTSMedia Articles Related to Plenaxis (Abarelix)
Among Patients Carrying BRCA Mutations, PARP Inhibitor Shows Activity In Pancreatic, Prostate Cancers
Source: Health News from Medical News Today [2013.05.18]
In the largest clinical trial to date to examine the efficacy of PARP inhibitor therapy in BRCA 1/2 carriers with diseases other than breast and ovarian cancer, the oral drug olaparib was found to be effective against advanced pancreatic and prostate cancers. Results of the study, led by researchers from the Perelman School of Medicine at the University of Pennsylvania and Sheba Medical Center in Tel Hashomer, Israel, will be presented during the American Society of Clinical Oncology's annual meeting in Chicago in early June (Abstract #11024)...
Advanced Prostate Cancer Drug Xofigo Approved By FDA
Source: Health News from Medical News Today [2013.05.17]
Xofigo (radium Ra 223 dichloride) has been approved by the US FDA for symptomatic late-stage (metastatic) castration-resistant prostate cancer that has reached bones but not other organs, i.e. with no known visceral metastatic disease. The Food and Drug Administration (FDA) approved Xifogo under the priority review program, three months ahead of schedule. According to an online FDA communiqué published this week, Xofigo is aimed at male patients whose prostate cancer metastasized despite receiving medical or surgical interventions to reduce testosterone levels...
Xofigo Approved for Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.17]
Title: Xofigo Approved for Prostate Cancer
Category: Health News
Created: 5/16/2013 4:36:00 PM
Last Editorial Review: 5/17/2013 12:00:00 AM
Androgen Deprivation Therapy For Prostate Cancer Can Cause Osteoporosis
Source: Bones / Orthopedics News From Medical News Today [2013.05.16]
Androgen deprivation therapy is a common and effective treatment for advanced prostate cancer. However, among other side-effects, it can cause significant bone thinning in men on long-term treatment...
FDA Approves New Drug to Fight Advanced Prostate Cancer
Source: MedicineNet Prostate Cancer Specialty [2013.05.16]
Title: FDA Approves New Drug to Fight Advanced Prostate Cancer
Category: Health News
Created: 5/15/2013 12:36:00 PM
Last Editorial Review: 5/16/2013 12:00:00 AM
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 and other gonadotrophin-releasing hormone antagonists in prostate cancer. [2009.12]
Hormonal therapy is the main recommended treatment for locally advanced and metastatic prostate cancer... Clinical data on both abarelix and degarelix show that they can produce rapid and sustained decreases in testosterone to castrate levels without the need for co-administration of an antiandrogen, and with a very low complication rate in the short term.
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.
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).
|
|
|
|
Page last updated: 2013-05-18
|
