INDICATIONS AND USAGE

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 in full Prescribing Information).

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 in full Prescribing Information).

Limitation of Use
Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure (see WARNINGS and PRECAUTIONS in full Prescribing Information) or in patients receiving definitive radiotherapy (see WARNINGS and PRECAUTIONS in full Prescribing Information), except in the context of a clinical study.

IMPORTANT SAFETY INFORMATION ABOUT ETHYOL

ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.

Patients should not receive ETHYOL if they are hypotensive or dehydrated or taking antihypertensive therapy that cannot be stopped for 24 hours preceding ETHYOL administration at doses recommended for chemotherapy. Patients should be adequately hydrated prior to receiving ETHYOL and blood pressure should be monitored during treatment.

Allergic manifestations including anaphylaxis and severe cutaneous reactions have been associated rarely with ETHYOL administration. Severe cutaneous reactions have been reported more frequently when ETHYOL is used as a radioprotectant and some reactions have been fatal, or have required hospitalization and/or discontinuance of therapy. Patients should be carefully monitored prior to, during, and after ETHYOL administration. Severe cutaneous reactions may develop weeks after initiation of ETHYOL administration. ETHYOL should be permanently discontinued for serious or severe cutaneous reactions alone or for any cutaneous reaction associated with fever or other constitutional symptoms not known to be due to another etiology.

Nausea and/or vomiting occur frequently after ETHYOL is given and may be severe. In a radiotherapy clinical trial, the most common side effects with ETHYOL were nausea/vomiting (53%) and hypotension (15%). Cutaneous eruptions have also been commonly reported during clinical trials and were generally nonserious. Other effects which have been described during, or following ETHYOL infusion include flushing, chills, malaise, fever, rash, dizziness, somnolence, hiccups, and sneezing. These events have not generally precluded completion of therapy.

It is recommended that antiemetic medication be administered prior to and in conjunction with ETHYOL. Oral 5HT₃ receptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting. When ETHYOL is administered with highly emetogenic chemotherapy, the fluid balance of the patient should be carefully monitored. Serum calcium levels should be monitored in patients at risk for hypocalcemia.

Please click here for full Prescribing Information for ETHYOL.

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