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Plenaxis (Abarelix) - Summary

 

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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.

PLENAXIS NEWS HIGHLIGHTS

Media Articles Related to Plenaxis (Abarelix)

Predicting Prostate Cancer Risk Through Incorporation Of Prostate Cancer Gene 3
Source: Cancer / Oncology News From Medical News Today [2008.10.02]

Diabetes And Mortality In Men With Locally Advanced Prostate Cancer: RTOG 92-02
Source: Diabetes News From Medical News Today [2008.10.02]

Scientists Establish New Blood Test To Better Evaluate Prostate Cancer
Source: Blood / Hematology News From Medical News Today [2008.10.01]

Additional Positive Findings For APOPTONE™ (HE3235) In Preclinical Models Of Castration-Resistant Prostate Cancer
Source: Clinical Trials / Drug Trials News From Medical News Today [2008.10.01]

ASTRO: Rectum Changes During Prostate Cancer Radiation May Affect Therapy
Source: MedPage Today Hematology/Oncology [2008.09.30]

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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]

A phase 3, multicenter, open-label, randomized study of abarelix versus leuprolide acetate in men with prostate cancer. [2001.11]

Abarelix for injectable suspension: first-in-class gonadotropin-releasing hormone antagonist for prostate cancer. [2006.12]

Dose-escalated abarelix in androgen-independent prostate cancer: a phase I study. [2006.10]

Abarelix: the first gonadotrophin-releasing hormone antagonist for the treatment of prostate cancer. [2004.10]

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Clinical Trials Related to Plenaxis (Abarelix)

The Plenaxis® Experience Study [Suspended]

Study of Abarelix in Androgen-Independent Prostate Cancer Progressing After Agonist Therapy [Completed]

more>>

Page last updated: 2008-10-02

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