Ethyol Side Effects

Generic Name: amifostine

Please note - some side effects for Ethyol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ethyol - for the Consumer

Ethyol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ethyol:

Drowsiness; feeling of coldness; flushing/feeling of warmth; hiccups; nausea; sneezing; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur when using Ethyol:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; chills or shaking; decreased urination; dizziness; fainting; fast, slow, or irregular heartbeat; fever; muscle twitching/cramping; numbness of an arm or leg; red, swollen, blistered, or peeling skin; seizures; severe or persistent nausea or vomiting; severe stomach pain; shortness of breath; sores on the lips, mouth, or tongue; sudden, severe headache; unusual fatigue or tiredness; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Ethyol Side Effects - for the Professional

Ethyol

Controlled Trials

In the randomized study of patients with ovarian cancer given Ethyol 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 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 due to blood pressure reductions. In the randomized study of patients with head and neck cancer given Ethyol at a dose of 200 mg/m2 prior to radiotherapy, hypotension was observed in 15% of patients treated.

TABLE 6 Incidence of Common Adverse Events in Patients Receiving Ethyol

* According to protocol-defined criteria. WR-1: requiring interruption of infusion; WR-38: drop of >20mm Hg.
	Phase III Ovarian Cancer Trial (WR-1) 910 mg/m2 _____________________________ Per Patient           Per Infusion		Phase III Head and Neck Cancer Trial (WR-38) 200 mg/m2 _____________________________ Per Patient           Per Infusion
Nausea/Vomiting   ≥Grade 3   All Grades	36/122 (30%) 117/122 (96%)	53/592 (9%) 520/592 (88%)	12/150 (8%) 80/150 (53%)	13/4314 (<1%) 233/4314 (5%)
Hypotension   ≥Grade 3*   All Grades	10/122 (8%) 75/122 (61%)	159/592 (27%)	4/150 (3%) 22/150 (15%)	46/4314 (1%)

In the randomized study of patients with head and neck cancer, 17% (26/150) discontinued Ethyol due to adverse events. All but one of these patients continued to receive radiation treatment until completion.

Hypotension that requires interruption of the Ethyol 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 can be administered. Short term, reversible loss of consciousness has been reported rarely.

Nausea and/or vomiting occur frequently after Ethyol 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, and 19% in patients who did receive Ethyol. In the randomized study of patients with head and neck cancer, the incidence of severe nausea/vomiting was 8% in patients who received Ethyol and 1% in patients who did not receive Ethyol.

Decrease in serum calcium concentrations is a known pharmacological effect of Ethyol. At the recommended doses, clinically significant hypocalcemia was reported in 1% of patients in the randomized head and neck cancer study.

Other effects, which have been described during, or following Ethyol 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 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 is higher in patients receiving Ethyol as a radioprotectant than in patients receiving Ethyol 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.

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 administration.

Seizures and syncope have been reported rarely.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects include a transient reduction in blood pressure in 62% of patients. Arrhythmias such as atrial fibrillation/flutter and supraventricular tachycardia have been reported. (These have sometimes been associated with hypotension or allergic reactions.) Transient hypertension and exacerbations of preexisting hypertension, and short term, reversible loss of consciousness have been reported rarely.

The mean time of onset until reduction in blood pressure was 14 minutes into the 15 minute amifostine infusion. The mean duration was six minutes. Blood pressure generally returned to normal within five to fifteen minutes.

In order to avoid hypotension, amifostine has sometimes been administered by the subcutaneous route.

Gastrointestinal

Gastrointestinal side effects frequently include nausea and/or vomiting which may be severe.

Other

These effects have not generally precluded the completion of therapy.

Other side effects include flushing/feeling of warmth, fever, malaise, chills/feeling of coldness, dizziness, somnolence, hiccups, syncope, and sneezing.

Hypersensitivity

In case of an acute allergic reaction, amifostine should be immediately and permanently discontinued. Epinephrine and other measures should be available for the treatment of serious allergic events such as anaphylaxis.

Hypersensitivity side effects have included hypotension, fever, chills/rigors, dyspnea, skin rashes, and urticaria. Anaphylactoid reactions including hypoxia, laryngeal edema, and chest tightness have also been reported. Anaphylactoid reactions associated with cardiac arrest have been reported rarely. A case of Stevens-Johnson syndrome has also been reported.

Dermatologic

Cutaneous eruptions have been commonly reported during clinical trials and were generally not serious.

Dermatologic side effects include skin rashes, pruritus, urticaria, erythema multiforme, and rarely Stevens-Johnson Syndrome or toxic epidermal necrolysis.

Nervous system

Nervous system side effects rarely include seizures.

Musculoskeletal

Musculoskeletal side effects including a case of amifostine-induced back pain have been reported.

Metabolic

Metabolic side effects including hypocalcemia (up to 1%) have been reported.

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