Ethyol® (amifostine) is a selective cytoprotective agent used to reduce toxicities associated with certain cancer chemotherapy and radiotherapy.
Specifically, Ethyol is an intravenous organic thiophosphate cytoprotective agent indicated to reduce the incidence of moderate to severe xerostomia (dry mouth) in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands. Ethyol is also indicated for the reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens or radiation therapy is altered by Ethyol. There are at present only limited data on the effects of Ethyol on the efficacy of chemotherapy or radiotherapy in other settings. Ethyol should not be administered to patients in other 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. (See package insert for more information.)
Important Safety Information
Approved indications
- Ethyol® (amifostine) 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.1
- Ethyol is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.1
- For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin-based chemotherapy regimes or radiation therapy is altered by Ethyol.1
- There are at present only limited data on the effects of Ethyol on the efficacy of chemotherapy or radiotherapy in other settings.1 Ethyol should not be administered to patients in other 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.
Safety information
- Nausea and/or vomiting occur frequently after Ethyol is given and may be severe.1 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. In a chemotherapy clinical trial, the most common side effects with Ethyol were nausea/vomiting (96%) and hypotension (61%).
- It is recommended that antiemetic medication be administered prior to and in conjunction with Ethyol.1 Oral 5HT3 receptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting. In the chemotherapy setting, it is recommended that antiemetic medication, including dexamethasone 20 mg IV and a serotonin 5HT3 receptor antagonist, be administered prior to and in conjunction with Ethyol. Additional antiemetics may be required based on the chemotherapy drugs administered.
- Patients who are hypotensive or dehydrated should not receive Ethyol.1 Patients should be adequately hydrated prior to Ethyol infusion and kept in a supine position during the infusion. When Ethyol is administered with highly emetogenic chemotherapy, the fluid balance of the patient should be carefully monitored. Patients who are taking antihypertensive therapy that cannot be stopped for 24 hours preceding Ethyol administration should not receive Ethyol at doses recommended for chemotherapy. Blood pressure should be monitored during treatment. Serum calcium levels should be monitored in patients at risk for hypocalcemia.
- Allergic manifestations including anaphylaxis and severe cutaneous reactions have been associated rarely with Ethyol administration.1 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. Patients should be carefully monitored prior to, during, and after Ethyol administration.
- Ethyol is contraindicated in patients with known sensitivity to aminothiol compounds.1
Reference: 1. Ethyol (amifostine) for injection package insert. Gaithersburg, Md: MedImmune Oncology, Inc.; 2005.
Download Package Insert (PDF)
