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Brand Name
Ethyol
Generic Name
Amifostine
View Brand Information FDA approval date: March 03, 2026
Classification: Cytoprotective Agent
Form: Injection
What is Ethyol (Amifostine)?
ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
Approved To Treat
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Brand Information
Ethyol (Amifostine)
1DOSAGE FORMS AND STRENGTHS
For Injection: sterile lyophilized white powder in 10 mL single-dose vials.
Each vial contains 500 mg of amifostine on the anhydrous basis.
2CONTRAINDICATIONS
ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
– Hypotension and Cardiovascular Events
– Severe Cutaneous Reactions
– Hypersensitivity
– Nausea and Vomiting
– Hypocalcemia
3.1Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ETHYOL was administered to patients receiving chemotherapeutic agents for advanced ovarian cancer (WR-1 study) or who were receiving standard fractionated radiotherapy for head and neck cancer (WR-38 study)
In the WR-38 study of patients with head and neck cancer, 17% (26/150) discontinued ETHYOL due to adverse reactions. All but one of these patients continued to receive radiation treatment until completion.
Table 2 summarizes adverse reactions reported in patients from the WR-1 and WR-38 clinical trials.
Other clinically relevant adverse reactions reported in patients in the WR-1 and WR-38 trials include the following:
Infusion-related Reactions: flushing/feeling of warmth, chills/feeling of coldness, malaise, pyrexia, rash, dizziness, somnolence, hiccups, diarrhea, sneezing, diplopia and blurred vision. These effects have not generally precluded the completion of therapy.
Injection site reactions (including rash/erythema, pruritus, urticaria, pain, inflammation, bruising and local swelling) were also observed.
3.2Post-Marketing Experience
The following adverse reactions have been identified during post-approval use of ETHYOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following reported post-marketing adverse reactions are described elsewhere in the labeling:
– Hypotension and Cardiovascular Events
– Severe Cutaneous Reactions
– Hypersensitivity
Adverse reactions associated with the use of ETHYOL that have been identified in other clinical trials and/or post-marketing reports are described below:
Immune system disorders:Hypersensitivity reactions including pruritus, urticaria, laryngeal edema, anaphylactic reactions, anaphylactoid reactions.
Nervous system disorders:Seizure.
Cardiac disorders:Myocardial ischemia, myocardial infarction, cardiac arrest, arrhythmias including tachycardia, bradycardia, atrial fibrillation/ flutter, supraventricular tachycardia, extrasystoles.
Vascular disorders:Transient hypertension and exacerbations of preexisting hypertension.
Respiratory, thoracic and mediastinal disorders:Apnea, dyspnea, hypoxia, respiratory arrest.
Skin and subcutaneous tissue disorders:Erythema multiforme, dermatitis exfoliative, Stevens-Johnson syndrome, toxic epidermal necrolysis.
Renal and urinary disorders:Renal failure.
General disorders and administration site conditions:Chest discomfort and chest pain.
4DRUG INTERACTIONS
Closely monitor patients receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension.
5USE IN SPECIFIC POPULATIONS
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5.1Pregnancy
Risk Summary
When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy information.
Based on findings in animals, ETHYOL can cause fetal harm when administered to a pregnant woman. There are no available data on ETHYOL use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, intravenous administration of ETHYOL to pregnant rabbits during organogenesis was embryotoxic at doses approximately sixty percent of the recommended dose in humans based on body surface area
The background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies in the U.S. general population.
Data
Animal Data
ETHYOL has been shown to be embryotoxic in rabbits at intravenous doses of 50 mg/kg, approximately sixty percent of the recommended dose in humans on a body surface area basis.
5.2Lactation
Risk Summary
When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for lactation information.
There are no data on the presence of amifostine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment with ETHYOL.
5.3Females and Males of Reproductive Potential
When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for contraception and infertility information.
Pregnancy Testing
Verify pregnancy status in females of reproductive potential prior to initiating ETHYOL.
Infertility
Males
Based on findings from animal studies, ETHYOL may impair fertility in males of reproductive potential
5.4Pediatric Use
The safety and effectiveness in pediatric patients have not been established.
5.5Geriatric Use
The clinical studies did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy in elderly patients.
6OVERDOSAGE
In clinical trials, the maximum single dose of ETHYOL was 1300 mg/m
The most likely symptom of overdosage is hypotension, which should be managed by infusion of normal saline and other supportive measures, as clinically indicated
7DESCRIPTION
ETHYOL (amifostine) is an organic thiophosphate cytoprotective agent known chemically as 2-[(3-aminopropyl)amino]ethanethiol dihydrogen phosphate (ester) and has the following structural formula:
Amifostine is a white crystalline powder which is freely soluble in water. Its empirical formula is C
ETHYOL is the trihydrate form of amifostine and is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-dose 10 mL vial contains 500 mg of amifostine on the anhydrous basis.
8REFERENCES
- “OSHA Hazardous Drugs." OSHA, http://www.osha.gov/SLTC/hazardousdrugs/index.html
9HOW SUPPLIED/STORAGE AND HANDLING
ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized white powder in 10 mL single-dose vials (NDC 83107-030-01). Each vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:
Carton containing 3 vials (NDC 83107-030-02)
Discard unused portion.
Store the lyophilized dosage form at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
Follow special handling and disposal procedures
10PATIENT COUNSELING INFORMATION
Hypotension and Cardiovascular Events
Inform the patient that he or she may experience hypotension after ETHYOL infusion
Severe Cutaneous Reactions
Inform the patient that severe cutaneous reactions may develop during or weeks after initiation of ETHYOL administration. Advise the patient to inform the prescriber if they experience any cutaneous reactions or mucosal lesions outside of the injection site or radiation port, or on the palms or soles, as discontinuation of the drug may be necessary
Hypersensitivity
Inform the patient that he or she may experience allergic reactions after ETHYOL infusion
Nausea and Vomiting
Inform the patient that he or she may experience severe nausea and/or vomiting after ETHYOL infusion
Hypocalcemia
Inform the patient that calcium supplements may be necessary if hypocalcemia is identified
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy
Lactation
Advise lactating women not to breastfed during treatment with ETHYOL
Infertility
Advise males of reproductive potential that ETHYOL may impair fertility
U.S. Patent 5,994,409
Manufactured for:
Legacy Pharma Inc.
George Town, Grand Cayman
KY1-9012
Distributed by:
Legacy Pharma USA Inc.
Scottsdale, AZ 85254
ETHYOL is a registered trademark of Legacy Pharma Inc.
For additional information, contact Legacy Pharma Inc. 1-800-727-7151.
Revision Date: 07/2023
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11PRINCIPAL DISPLAY PANEL
NDC 83107-030-02
Rx only
ETHYOL
(amifostine) for Injection
500 mg per vial
For Intravenous Use
Sterile
3 VIALS
LEGACY PHARMA
