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Ethyol Side Effects Center
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.
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ethyol Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: fainting, fast/slow/irregular heartbeat, seizure.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: fever, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Ethyol (Amifostine)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ethyol FDA Prescribing Information: Side Effects
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) »
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