Chinese Association of Idaho State University (CAISU)
Degarelix (degarelix for injection)
Degarelix (degarelix for injection)
Degarelix is a Gonadotropin-releasing hormone (GnRH) receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone.Degarelix powder
Degarelix is specifically indicated for the treatment of advanced prostate cancer.
Degarelix is supplied as a powder to be reconstituted with sterile water for subcutaneous administration in the abdomen. The recommended initial dose of the drug is 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL. The recommended maintenance dose of Degarelix is 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL, every 28 days.
Clinical Results
FDA Approval
FDA approval of Degarelix was based on the results of a clinical trial. This open-label, multi-center, randomized, parallel-group study enrolled 620 subjects with prostate cancer. The subjects received one of two Degarelix dosing regimens or leuprolide for one year: Group A) Degarelix at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 160 mg (40 mg/mL) subcutaneously; Group B) Degarelix at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 80 mg (20 mg/mL) subcutaneously; or Group C) leuprolide 7.5 mg intramuscularly monthly. The primary objective was to demonstrate that Degarelix is effective with respect to achieving and maintaining testosterone suppression to castration levels (T < 50 ng/dL), during 12 months treatment. In Group A (240/160 mg) there were 199 responders and the castration rate was 98.3%; in Group B (240/80 mg) there were 202 responders and the castration rate was 97.2%; and in Group C (leuprolide 7.5 mg) there were 194 responders and the castration rate was 96.4%.
Ongoing Study Commitments
Ferring has agreed to complete the ongoing extension study FE200486 CS21A entitled “An Open-Label, Multi-Center, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy".
Protocol Submission: January 2007
Trial Start Date: March 2007
First Annual Report Submission: March 2009
Second Annual Report Submission: March 2010
Third Annual Report Submission: March 2011
Final Report and Dataset Submission: June 2012
Side Effects
Adverse events associated with the use of Degarelix may include, but are not limited to, the following:
hot flashes
injection site reactions
weight gain
increase in liver enzymes
tiredness
hypertension
back and joint pain
chills
urinary tract infection
decreased sex drive and trouble with erectile function
Degarelix is a Gonadotropin-releasing hormone (GnRH) receptor antagonist. It binds reversibly to the pituitary GnRH receptors, thereby reducing the release of gonadotropins and consequently testosterone.Degarelix powder
Degarelix is specifically indicated for the treatment of advanced prostate cancer.
Degarelix is supplied as a powder to be reconstituted with sterile water for subcutaneous administration in the abdomen. The recommended initial dose of the drug is 240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL. The recommended maintenance dose of Degarelix is 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL, every 28 days.
Clinical Results
FDA Approval
FDA approval of Degarelix was based on the results of a clinical trial. This open-label, multi-center, randomized, parallel-group study enrolled 620 subjects with prostate cancer. The subjects received one of two Degarelix dosing regimens or leuprolide for one year: Group A) Degarelix at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 160 mg (40 mg/mL) subcutaneously; Group B) Degarelix at a starting dose of 240 mg (40 mg/mL) followed by monthly doses of 80 mg (20 mg/mL) subcutaneously; or Group C) leuprolide 7.5 mg intramuscularly monthly. The primary objective was to demonstrate that Degarelix is effective with respect to achieving and maintaining testosterone suppression to castration levels (T < 50 ng/dL), during 12 months treatment. In Group A (240/160 mg) there were 199 responders and the castration rate was 98.3%; in Group B (240/80 mg) there were 202 responders and the castration rate was 97.2%; and in Group C (leuprolide 7.5 mg) there were 194 responders and the castration rate was 96.4%.
Ongoing Study Commitments
Ferring has agreed to complete the ongoing extension study FE200486 CS21A entitled “An Open-Label, Multi-Center, Extension Study, Evaluating the Long-Term Safety and Tolerability of Degarelix One Month Dosing Regimen in Patients with Prostate Cancer Requiring Androgen Ablation Therapy".
Protocol Submission: January 2007
Trial Start Date: March 2007
First Annual Report Submission: March 2009
Second Annual Report Submission: March 2010
Third Annual Report Submission: March 2011
Final Report and Dataset Submission: June 2012
Side Effects
Adverse events associated with the use of Degarelix may include, but are not limited to, the following:
hot flashes
injection site reactions
weight gain
increase in liver enzymes
tiredness
hypertension
back and joint pain
chills
urinary tract infection
decreased sex drive and trouble with erectile function
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