|
1 Indications And Usage Ethyol Is A Cytoprotective Agent Indicated For: Reduction Of Cumulative Renal Toxicity Associated With Repeated Administration Of Cisplatin In Patients With Advanced Ovarian Cancer. ( 1.1 ) Reduction Of The Incidence Of Moderate To Severe Xerostomia In Patients Undergoing Post-Operative Radiation Treatment For Head And Neck Cancer, Where The Radiation Port Includes A Substantial Portion Of The Parotid Glands. ( 1.2 ) Limitation Of Use Avoid The Use Of Ethyol In Settings Where Chemotherapy Can Produce A Significant Survival Benefit Or Cure, Or In Patients Receiving Definitive Radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction Of Cumulative Renal Toxicity With Chemotherapy Ethyol (Amifostine) Is Indicated To Reduce The Cumulative Renal Toxicity Associated With Repeated Administration Of Cisplatin In Patients With Advanced Ovarian Cancer [See Clinical Studies ( 14.1 )] . 1.2 Reduction Of Moderate To Severe Xerostomia From Radiation Of The Head And Neck Ethyol Is Indicated To Reduce The Incidence Of Moderate To Severe Xerostomia In Patients Undergoing Post-Operative Radiation Treatment For Head And Neck Cancer, Where The Radiation Port Includes A Substantial Portion Of The Parotid Glands [See Clinical Studies ( 14.2 )] . Limitation Of Use Do Not Use Ethyol In Other Settings Where Chemotherapy Can Produce A Significant Survival Benefit Or Cure [See Warnings And Precautions ( 5.1 )] , Or In Patients Receiving Definitive Radiotherapy [See Warnings And Precautions ( 5.2 )] , Except In The Context Of A Clinical Study.
|