Medical Editor: John P. Cunha, DO, FACOEP
Ethyol (amifostine) for Injection is a thiophosphate cytoprotective drug used to decrease the risk of kidney problems caused by treatment with a certain anti-cancer drug (cisplatin). Ethyol is also used to help prevent a certain side effect (dry mouth) caused by radiation treatment for head and neck cancer. Ethyol is available in generic form. Common side effects of Ethyol include:
- nausea and vomiting (can be frequent and severe)
- lushing (warmth, redness, or tingly feeling)
- unusual feelings of warmth or cold
- fever, or
- general ill feeling
The recommended starting dose of Ethyol is 910 mg/m2 administered once daily as a 15-minute IV infusion, starting 30 minutes prior to chemotherapy. Ethyol may interact with blood pressure medications, antihistamines, anti-seizure drugs, medicine for sleep or anxiety, muscle relaxants, narcotics, psychiatric medicines, or cough-and-cold products. Tell your doctor all medications and supplements you use. During pregnancy, Ethyol should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Ethyol (amifostine) for Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives, itching; chest tightness, difficult breathing; fever or chills; swelling of your face, lips, tongue, or throat.
Some of the side effects of amifostine may occur up to several weeks after you receive this medication.
Tell your caregiver right away if you have a serious side effect such as:
- feeling like you might pass out;
- chest pain, fast or slow heart rate;
- weak or shallow breathing;
- seizure (convulsions);
- urinating less than usual or not at all;
- severe skin rash on your stomach, back, or trunk;
- redness, rash, or blisters on the palms of your hands or the soles of your feet; or
- severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Less serious side effects may include:
- nausea, vomiting;
- dizziness, drowsiness;
- flushing (warmth, redness, or tingly feeling);
- cold feeling;
- sneezing; or
- mild fever, general ill feeling.
Read the entire detailed patient monograph for Ethyol (Amifostine)
In the randomized study of patients with ovarian cancer given ETHYOL (amifostine) at a dose of 910 mg/m2 prior to chemotherapy, transient hypotension was observed in 62% of patients treated. The mean time of onset was 14 minutes into the 15-minute period of ETHYOL (amifostine) infusion, and the mean duration was 6 minutes. In some cases, the infusion had to be prematurely terminated due to a more pronounced drop in systolic blood pressure. In general, the blood pressure returned to normal within 5-15 minutes. Fewer than 3% of patients discontinued ETHYOL (amifostine) due to blood pressure reductions. In the randomized study of patients with head and neck cancer given ETHYOL (amifostine) at a dose of 200 mg/m2 prior to radiotherapy, hypotension was observed in 15% of patients treated. (see TABLE 6)
TABLE 6: Incidence of Common Adverse Events in Patients Receiving
|Phase III Ovarian Cancer Trial(WR-1) 910mg/m2||Phase III Head and Neck Cancer Trial (WR-38) 200mg/m2|
|Per Patient||Per Infusion||Per Patient||Per Infusion|
|≥ Grade 3||36/122 (30%)||53/592 (9%)||12/150 (8%)||13/4314 (<1%)|
|All Grades||117/122 (96%)||520/592 (88%)||80/150 (53%)||233/4314 (5%)|
|≥ Grade 3a||10/122 (8%)||4/150 (3%)|
|All Grades||75/122 (61%)||159/592 (27%)||22/150 (15%)||46/4314 (1%)|
|aAccording to protocol-definedcriteria. WR-1:requiring interruption of infusion; WR-38: drop of >20mm Hg.|
In the randomized study of patients with head and neck cancer, 17% (26/150) discontinued ETHYOL (amifostine) due to adverse events. All but one of these patients continued to receive radiation treatment until completion.
Hypotension that requires interruption of the ETHYOL (amifostine) infusion should be treated with fluid infusion and postural management of the patient (supine or Trendelenburg position). If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted, so that the full dose of ETHYOL (amifostine) can be administered. Short term, reversible loss of consciousness has been reported rarely.
Nausea and/or vomiting occur frequently after ETHYOL (amifostine) infusion and may be severe. In the ovarian cancer randomized study, the incidence of severe nausea/vomiting on day 1 of cyclophosphamide-cisplatin chemotherapy was 10% in patients who did not receive ETHYOL (amifostine) , and 19% in patients who did receive ETHYOL (amifostine) . In the randomized study of patients with head and neck cancer, the incidence of severe nausea/vomiting was 8% in patients who received ETHYOL (amifostine) and 1% in patients who did not receive ETHYOL (amifostine) .
Decrease in serum calcium concentrations is a known pharmacological effect of ETHYOL (amifostine) . At the recommended doses, clinically significant hypocalcemia was reported in 1% of patients in the randomized head and neck cancer study (see WARNINGS), and not reported in the ovarian cancer study.
Other effects, which have been described during, or following ETHYOL (amifostine) infusion are flushing/feeling of warmth, chills/feeling of coldness, malaise, fever, rash, dizziness, somnolence, hiccups and sneezing. These effects have not generally precluded the completion of therapy.
Clinical Trials and Pharmacovigilance Reports
Allergic reactions characterized by one or more of the following manifestations have been observed during or after ETHYOL (amifostine) administration: hypotension, fever, chills/rigors, dyspnea, hypoxia, chest tightness, cutaneous eruptions, pruritus, urticaria and laryngeal edema. Cutaneous eruptions have been commonly reported during clinical trials and were generally non-serious. Serious, sometimes fatal skin reactions including erythema multiforme, and in rare cases, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis have also occurred. The reported incidence of serious skin reactions associated with ETHYOL (amifostine) is higher in patients receiving ETHYOL (amifostine) as a radioprotectant than in patients receiving ETHYOL (amifostine) as a chemoprotectant. Rare anaphylactoid reactions and cardiac arrest have also been reported.
Hypotension, usually brief systolic and diastolic, has been associated with one or more of the following adverse events: apnea, dyspnea, hypoxia, tachycardia, bradycardia, extrasystoles, chest pain, myocardial ischemia and convulsion. Rare cases of renal failure, myocardial infarction, respiratory and cardiac arrest have been observed during or after hypotension. (See WARNINGS and PRECAUTIONS)
Rare cases of arrhythmias such as atrial fibrillation/flutter and supraventricular tachycardia have been reported. These are sometimes associated with hypotension or allergic reactions.
Transient hypertension and exacerbations of preexisting hypertension have been observed rarely after ETHYOL (amifostine) administration.
Read the entire FDA prescribing information for Ethyol (Amifostine)
© Ethyol Patient Information is supplied by Cerner Multum, Inc. and Ethyol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.