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ETHYOL^® is 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 (see Clinical Studies in full Prescribing Information).

For the approved indication, the clinical data do not suggest that the effectiveness of radiation therapy is altered by ETHYOL. There are at present only limited data on the effects of ETHYOL on the efficacy of radiotherapy in other settings. ETHYOL should not be administered to patients receiving definitive radiotherapy, except in the context of a clinical study (see WARNINGS in full Prescribing Information).

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 see full Prescribing Information for ETHYOL.