ETHYOL® (amifostine) for injection is a cytoprotective agent indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer, and to reduce the incidence of moderate to severe xerostomia in patients undergoing postoperative radiation treatment for head and neck cancer where the radiation port includes a substantial portion of the parotid glands.
The effectiveness of ETHYOL to reduce the cumulative renal toxicity of cisplatin has not been established in tumors other than advanced ovarian cancer. ETHYOL should not be administered in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study.
ETHYOL U.S. Launch Overview — provided by Legacy Pharma / CNX Therapeutics.
ETHYOL is approved in two distinct oncology settings. Select the pathway that matches your patient scenario.
Indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
Indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing postoperative radiation treatment for head and neck cancer where the radiation port includes a substantial portion of the parotid glands.
The effectiveness of ETHYOL to reduce the cumulative renal toxicity of cisplatin has not been established in tumors other than advanced ovarian cancer. ETHYOL should not be administered in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study.
ETHYOL (amifostine) is an organic thiophosphate prodrug that is dephosphorylated in tissue to its active free thiol metabolite. Consistent with its label, ETHYOL is used to reduce the cumulative renal toxicity of cisplatin in advanced ovarian cancer and to reduce moderate to severe xerostomia in postoperative head and neck radiotherapy where the radiation port includes a substantial portion of the parotid glands.
The information here is intentionally aligned to the current U.S. Prescribing Information and does not make antitumor-efficacy claims.
Clinical Pharmacology in PI →ETHYOL 910 mg/m² administered prior to each cycle of cisplatin was studied for reduction of cumulative renal toxicity, as characterized on the current U.S. Prescribing Information.
View source →ETHYOL 200 mg/m² administered prior to each fraction of standard fraction radiotherapy was studied for reduction of moderate to severe xerostomia, as described in the current U.S. Prescribing Information.
View source →The most common adverse reactions include hypotension, nausea, and vomiting. See the current U.S. Prescribing Information for the complete adverse reaction profile.
View source →Adequate hydration prior to infusion, antiemetic premedication, supine positioning during infusion, and blood pressure monitoring every 5 minutes during infusion are specified in the U.S. Prescribing Information.
View source →For radiotherapy, ETHYOL is administered as a 3-minute IV infusion beginning 15 to 30 minutes prior to standard fraction radiotherapy, with hydration and antiemetic premedication as described in the label.
View source →Visualization of label-aligned content available in this explorer. Not a clinical outcome.
Follow the U.S. Prescribing Information for hydration, antiemetic premedication, patient positioning, blood-pressure monitoring, timing, and infusion instructions.
Ensure adequate hydration prior to infusion, per the U.S. Prescribing Information.
Administer dexamethasone and a 5-HT3 antagonist prior to and in conjunction with ETHYOL.
Place patient in the supine position for the duration of the infusion.
Monitor blood pressure every 5 minutes during infusion.
Administer 910 mg/m² as a 15-minute IV infusion, starting 30 minutes prior to cisplatin.
Ensure adequate hydration prior to infusion.
Administer antiemetic medication, including dexamethasone and a 5-HT3 antagonist, prior to and in conjunction with ETHYOL.
Place patient in the supine position for the duration of the infusion.
Monitor blood pressure every 5 minutes during infusion.
Administer 200 mg/m² as a 3-minute IV infusion, starting 15 to 30 minutes prior to standard fraction radiation therapy.
Systolic BP monitoring thresholds during ETHYOL infusion — see full instructions and post-interruption criteria in the U.S. Prescribing Information.
| Baseline systolic BP | Decrease from baseline prompting interruption |
|---|---|
| < 100 mmHg | 20 mmHg |
| 100 – 119 mmHg | 25 mmHg |
| 120 – 139 mmHg | 30 mmHg |
| 140 – 179 mmHg | 40 mmHg |
| ≥ 180 mmHg | 50 mmHg |
Interpret alongside the full BP interruption and resumption criteria in the U.S. Prescribing Information.
Review the complete Important Safety Information below and see the U.S. Prescribing Information for details.
Current U.S. Prescribing Information from DailyMed — the authoritative source.
Open PI →Printable label view from DailyMed for clinical reference.
Print label →CNX Therapeutics and Legacy Pharma July 2026 U.S. commercial partnership and launch announcement.
Read announcement →U.S. packager and distributor of ETHYOL — corporate site.
Visit Legacy Pharma →Commercial and general inquiries directly to Legacy Pharma USA Inc.
Contact →Report suspected adverse events and product problems to the FDA.
Report to MedWatch →Official launch video — asset slot to be populated at launch.
Coming soonDownloadable HCP administration reference — approved asset slot.
Coming soonLabel-aligned animation of cytoprotective mechanism — approved asset slot.
Coming soonAdditional promotional or medical materials as released by Legacy Pharma.
Coming soonETHYOL is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer, and to reduce the incidence of moderate to severe xerostomia in patients undergoing postoperative radiation treatment for head and neck cancer where the radiation port includes a substantial portion of the parotid glands.
Please route safety and adverse event reports through the safety channels below. Commercial and general inquiries go to Legacy Pharma.
U.S. packager and distributor of ETHYOL. Use this channel for non-safety commercial questions.
Contact Legacy Pharma →Report suspected adverse events or product complaints to Legacy Pharma and/or the FDA MedWatch program.