Included In This Lesson
Outline
What is the Generic Name
AMIFOSTINE
What is the Trade Name for AMIFOSTINE
Ethyol
What is the Indication for AMIFOSTINE
- 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.
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References: https://open.fda.gov/
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