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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:
H2N(CH2)3NH(CH2)2S-PO3H2
Amifostine is a white crystalline powder which is freely soluble in water. Its empirical formula is C5H15N2O3PS and it has a molecular weight of 214.22.
ETHYOL is the trihydrate form of amifostine and is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use 10 mL vial contains 500 mg of amifostine on the anhydrous basis.
ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer [see Clinical Studies].
ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands [see Clinical Studies].
Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see WARNINGS AND PRECAUTIONS], or in patients receiving definitive radiotherapy [see WARNINGS AND PRECAUTIONS], except in the context of a clinical study.
Prior to ETHYOL infusion, verify that patients are adequately hydrated and correct existing dehydration if clinically indicated.
When administering ETHYOL at the 910 mg/m2 dose, antiemetic medications, including intravenous dexamethasone 20 mg and a serotonin 5HT3 receptor antagonist, are recommended prior to ETHYOL administration. Additional antiemetics may be required based on the chemotherapy drugs administered.
When administering ETHYOL at the 200 mg/m2 dose, it is recommended that antiemetic medication be administered prior to ETHYOL administration. Oral 5HT3 receptor antagonists, alone or in combination with other antiemetics are recommended in the radiotherapy setting.
Patients should be kept in a supine position during the ETHYOL infusion.
When administering ETHYOL at the 910 mg/m2 dose, monitor blood pressure before, at least every 5 minutes during the infusion, at the end of the infusion, and thereafter as clinically indicated.
When administering ETHYOL at the 200 mg/m2 dose, monitor blood pressure before and at the end of the infusion, and thereafter as clinically indicated.
The recommended starting dose of ETHYOL is 910 mg/m2 administered as a 15-minute intravenous infusion, starting 30 minutes prior to chemotherapy. Do not exceed a 15-minute infusion time due to the increased risk of infusion-related reactions. The use of less than 15-minute infusion times for ETHYOL use with chemotherapy have not been established.
The recommended dose of ETHYOL is 200 mg/m2 administered as a 3-minute intravenous infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy).
The infusion of ETHYOL should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in Table 1.
If severe infusion-related reactions occur, immediately and permanently discontinue ETHYOL.
Table 1: Interrupting ETHYOL Infusion Due to Decreases in Systolic Blood
| Baseline Systolic Blood Pressure (mm Hg) | |||||
| Decrease in systolic blood pressure during infusion of ETHYOL (mm Hg) | <100 | 100-119 | 120-139 | 140-179 | ≥180 |
| 20 | 25 | 30 | 40 | 50 | |
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 may be administered.
When administering ETHYOL at the 910 mg/m2 dose, if the full dose of ETHYOL cannot be administered, the dose of ETHYOL for subsequent chemotherapy cycles should be 740 mg/m2 .
During reconstitution of ETHYOL, the use of gloves is recommended, and avoid contact with the skin or mucous membranes. Follow special handling and disposal procedures [see REFERENCES].
A vial of ETHYOL may contain more drug than is required for the recommended dose or multiple vials may be needed to obtain the recommended dose. Reconstitute ETHYOL with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution contains a concentration of 50 mg/m2L amifostine, and should be colorless. The reconstituted solution is chemically stable for up to 5 hours at room temperature (approximately 25°C) or up to 24 hours under refrigeration (2°C to 8°C).
Further dilute to ETHYOL with 0.9% Sodium Chloride Injection, USP to a final concentration of 5 mg/m2L to 40 mg/m2L before administration. ETHYOL prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/m2L to 40 mg/m2L is chemically stable for up to 5 hours when stored at room temperature (approximately 25°C) or up to 24 hours when stored under refrigeration (2°C to 8°C).
Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use ETHYOL if cloudiness or precipitate is observed.
The compatibility of ETHYOL with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.
sterile lyophilized white powder in 10 mL single-dose vials. Each vial contains 500 mg of amifostine on the anhydrous basis.
ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized white powder in 10 mL single-dose vials (NDC 76310-017-50). Each vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:
Carton containing 3 vials (NDC 76310-017-50)
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 [see REFERENCES].
REFERENCES
1. "OSHA Hazardous Drugs." OSHA, https://www.osha.gov/SLTC/hazardousdrugs/index.html
Manufactured for: Clinigen, Inc. Yardley, PA 19067. Revised: Dec 2019
Included as part of the "PRECAUTIONS" Section
ETHYOL may interfere with the antitumor activity of chemotherapy regimens. Do not use ETHYOL in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure (e.g., certain malignancies of germ cell origin), except in the context of a clinical study. Limited data are currently available regarding interference with antitumor efficacy when ETHYOL is administered prior to cisplatin therapy in settings other than advanced ovarian cancer.
ETHYOL may interfere with the antitumor activity of the radiotherapy regimens. Do not use ETHYOL in patients receiving definitive radiotherapy, except in the context of a clinical trial, since there are insufficient data to exclude a tumor-protective effect in this setting. ETHYOL was studied with standard fractionated radiotherapy and when ≥75% of both parotid glands were exposed to radiation. The safety and efficacy of ETHYOL on the incidence of xerostomia in the setting of combined chemotherapy and radiotherapy, and in the setting of accelerated or hyperfractionated therapy, have not been established.
Severe hypotension with serious sequelae have been reported in clinical studies and post-marketing experience in patients treated with ETHYOL. Severe hypotension events included apnea, dyspnea, hypoxia, chest pain, tachycardia, bradycardia, extrasystoles, supraventricular tachycardia, atrial fibrillation/flutter, myocardial ischemia, myocardial infarction, unconsciousness, syncope, seizure, renal failure, and respiratory and cardiac arrest.
In the WR-1 study of patients with ovarian cancer dosing ETHYOL at 910 mg/m2 , transient hypotension was observed in 62% of the patients treated, with 8% of the patients experiencing > Grade 3 hypotension. The mean time of onset was 14 minutes after initiation of the ETHYOL infusion, the mean duration of hypotension was 6 minutes, and blood pressure returned to normal within 15 minutes after the onset of hypotension in most cases. Approximately 3% of patients permanently discontinued ETHYOL due to severe hypotension.
In the WR-38 study of patients with head and neck cancer administering ETHYOL at a dose of 200 mg/m2 prior to radiotherapy, hypotension was observed in 15% of patients treated, with 3% of the patients experiencing ≥ Grade 3 hypotension.
Before administration of ETHYOL, verify that patients are not hypotensive or dehydrated. Adequately hydrate patients prior to initiating ETHYOL infusion.
Patients receiving ETHYOL at doses recommended for chemotherapy should have antihypertensive therapy interrupted 24 hours preceding administration of ETHYOL. Patients receiving ETHYOL at doses recommended for chemotherapy who are taking antihypertensive therapy that cannot be stopped for 24 hours preceding ETHYOL treatment should avoid treatment with ETHYOL. During and after ETHYOL infusion, closely monitor the blood pressure of patients whose antihypertensive medication has been interrupted since hypertension may be exacerbated by discontinuation of antihypertensive medication or other causes such as intravenous hydration.
During ETHYOL infusion, keep patients in a supine position and monitor blood pressure every 5 minutes during the infusion, and thereafter as clinically indicated. For infusion durations less than 5 minutes, blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated.
It is important that the duration of the 910 mg/m2 infusion does not exceed 15 minutes, as administration of ETHYOL as a longer infusion is associated with a higher incidence of adverse reactions.
If hypotension occurs, place patients in the Trendelenburg position and give an infusion of normal saline using a separate intravenous line. 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. Guidelines for interrupting and restarting ETHYOL infusion if a decrease in systolic blood pressure should occur are provided [see DOSAGE AND ADMINISTRATION].
Fatal and severe cutaneous reactions have been reported in clinical studies and post-marketing experience in patients treated with ETHYOL. Severe cutaneous reactions include erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy–confirmed eosinophilia and systemic symptoms (DRESS).
These reactions have been reported more frequently when ETHYOL is used as a radioprotectant [see ADVERSE REACTIONS]. Severe cutaneous reactions may develop weeks after initiation of ETHYOL administration. Monitor patients carefully prior to, during, and after ETHYOL administration.
Discontinue ETHYOL for cutaneous reactions or mucosal lesions appearing outside of the injection site or radiation port and for erythematous, edematous or bullous lesions on the palms or soles.
Hypersensitivity reactions, including anaphylaxis, have been reported in clinical studies and post-marketing experience with ETHYOL administration. Hypersensitivity and anaphylactic reactions observed during or after ETHYOL administration have included pyrexia, chills, dyspnea, hypoxia, chest discomfort, cutaneous eruptions, pruritus, urticaria, and laryngeal edema.
Epinephrine and other appropriate measures should be available for treatment of serious infusion-related reactions when administering ETHYOL. When severe allergic reactions occur, immediately and permanently discontinue ETHYOL.
Nausea and/or vomiting occur frequently after ETHYOL infusion and may be severe. In the WR-1 study of patients with ovarian cancer dosing ETHYOL at 910 mg/m2 , vomiting was observed in 96% of the patients treated, with severe nausea/vomiting on day 1 of cyclophosphamide-cisplatin chemotherapy in 19% of patients.
In the WR-38 study of patients with head and neck cancer administering ETHYOL at a dose of 200 mg/m2 prior to radiotherapy, vomiting was observed in 53% of patients treated, with severe nausea/vomiting in 8% of patients.
Administer antiemetic medication(s) prior to and in conjunction with ETHYOL [see DOSAGE AND ADMINISTRATION]. When ETHYOL is administered with highly emetogenic chemotherapy, closely monitor the fluid balance of the patient.
Monitor serum calcium levels in patients at risk of hypocalcemia, such as those with nephrotic syndrome, or patients receiving multiple doses of ETHYOL.
At the recommended doses, clinically significant hypocalcemia was reported in 1% of patients in the head and neck cancer study (WR-38).
If necessary, calcium supplements can be administered.
Based on findings in animals, ETHYOL can cause fetal harm when administered to a pregnant woman. 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. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for pregnancy and contraception information.
Carcinogenicity studies have not been conducted with ETHYOL.
ETHYOL was negative in the Ames test and in the mouse micronucleus test. The free thiol metabolite was positive in the Ames test with S9 microsomal fraction in the TA1535 Salmonella typhimurium strain and at the TK locus in the mouse L5178Y cell assay. The metabolite was negative in the mouse micronucleus test and negative for clastogenicity in human lymphocytes.
Fertility studies in animals have not been conducted with amifostine. In a 3-month repeat-dose toxicity study in rats, intravenous administration of amifostine resulted in bilateral degeneration of the germinal epithelium of the testes and bilateral hypospermia in the epididymides at doses of 50 mg/kg/day (approximately 0.3 times the maximum clinical dose based on body surface area).
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 (see Data). Advise pregnant women and females of reproductive potential of the potential risk to a fetus.
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.
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.
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.
When ETHYOL is used in combination with cisplatin, refer to the cisplatin full prescribing information for contraception and infertility information.
Verify pregnancy status in females of reproductive potential prior to initiating ETHYOL.
Males
Based on findings from animal studies, ETHYOL may impair fertility in males of reproductive potential [see Nonclinical Toxicology].
The safety and effectiveness in pediatric patients have not been established.
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.
In clinical trials, the maximum single dose of ETHYOL was 1300 mg/m2 . No information is available on single doses higher than this in adults. At the higher doses, anxiety and reversible urinary retention occurred.
The most likely symptom of overdosage is hypotension, which should be managed by infusion of normal saline and other supportive measures, as clinically indicated [see WARNINGS AND PRECAUTIONS].
ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.
ETHYOL is a prodrug that is dephosphorylated by alkaline phosphatase in tissues to a pharmacologically active free thiol metabolite. This metabolite is believed to be responsible for the reduction of the cumulative renal toxicity of cisplatin and for the reduction of the toxic effects of radiation on normal oral tissues. The ability of ETHYOL to differentially protect normal tissues is attributed to the higher capillary alkaline phosphatase activity, higher pH and better vascularity of normal tissues relative to tumor tissue, which results in a more rapid generation of the active thiol metabolite as well as a higher rate constant for uptake into cells. The higher concentration of the thiol metabolite in normal tissues is available to bind to, and thereby detoxify, reactive metabolites of cisplatin. This thiol metabolite can also scavenge reactive oxygen species generated by exposure to either cisplatin or radiation.
Clinical pharmacokinetic studies show that ETHYOL is rapidly cleared from the plasma with a distribution half-life of < 1 minute and an elimination half-life of approximately 8 minutes. Less than 10% of ETHYOL remains in the plasma 6 minutes after drug administration. ETHYOL is rapidly metabolized to an active free thiol metabolite. A disulfide metabolite is produced subsequently and is less active than the free thiol. After a 10-second bolus dose of 150 mg/m2 of ETHYOL, renal excretion of the parent drug and its two metabolites was low during the hour following drug administration, averaging 0.69%, 2.64% and 2.22% of the administered dose for the parent, thiol and disulfide, respectively. Measurable levels of the free thiol metabolite have been found in bone marrow cells 5-8 minutes after intravenous infusion of ETHYOL. Pretreatment with dexamethasone or metoclopramide has no effect on ETHYOL pharmacokinetics.
A randomized controlled trial compared six cycles of cyclophosphamide 1000 mg/m2, and cisplatin 100 mg/m2 with or without ETHYOL pretreatment at 910 mg/m2, in two successive cohorts of 121 patients with advanced ovarian cancer. In both cohorts, after multiple cycles of chemotherapy, pretreatment with ETHYOL significantly reduced the cumulative renal toxicity associated with cisplatin as assessed by the proportion of patients who had ≥40% decrease in creatinine clearance from pretreatment values, protracted elevations in serum creatinine (>1.5 mg/dL), or severe hypomagnesemia. Subgroup analyses suggested that the effect of ETHYOL was present in patients who had received nephrotoxic antibiotics, or who had preexisting diabetes or hypertension (and thus may have been at increased risk for significant nephrotoxicity), as well as in patients who lacked these risks. Selected analyses of the effects of ETHYOL in reducing the cumulative renal toxicity of cisplatin in the randomized ovarian cancer study are provided in TABLES 1 and 2, below.
TABLE 1
Proportion of Patients with ≥40% Reduction in Calculated Creatinine Clearance*
| ETHYOL + CP | CP | p-value (2-sided) |
|
| All Patients | 16/122 (13%) | 36/120 (30%) | 0.001 |
| First Cohort | 10/63 | 20/58 | 0.018 |
| Second Cohort | 6/59 | 16/62 | 0.026 |
| *Creatinine clearance values were calculated using the Cockcroft-Gault formula, Nephron 1976; 16:31-41. | |||
TABLE 2
NCI Toxicity Grades of Serum Magnesium Levels
for Each Patient's Last Cycle of Therapy
| NCI-CTC Grade: (mEq/L) |
0 >1.4 |
1 ≤1.4->1.1 |
2 ≤1.1->0.8 |
3 ≤0.8->0.5 |
4 ≤0.5 |
p-value* |
| All Patients | 0.001 | |||||
| ETHYOL+CP | 92 | 13 | 3 | 0 | 0 | |
| CP | 73 | 18 | 7 | 5 | 1 | |
| First Cohort | 0.017 | |||||
| ETHYOL+CP | 49 | 10 | 3 | 0 | 0 | |
| CP | 35 | 8 | 6 | 3 | 1 | |
| Second Cohort | 0.012 | |||||
| ETHYOL+CP | 43 | 3 | 0 | 0 | 0 | |
| CP | 38 | 10 | 1 | 2 | 0 | |
| * Based on 2-sided Mantel-Haenszel Chi-Square statistic. | ||||||
In the randomized ovarian cancer study, ETHYOL had no detectable effect on the antitumor efficacy of cisplatin-cyclophosphamide chemotherapy. Objective response rates (including pathologically confirmed complete remission rates), time to progression, and survival duration were all similar in the ETHYOL and control study groups. The table below summarizes the principal efficacy findings of the randomized ovarian cancer study.
TABLE 3
Comparison of Principal Efficacy Findings
| ETHYOL + CP | CP | |
| Complete pathologic tumor response rate | 21.3% | 15.8% |
| Time to progression (months) | ||
| Median (± 95% CI) | 15.8 (13.2, 25.1) | 18.1 (12.5, 20.4) |
| Mean (± Std error) | 19.8 (±1.04) | 19.1 (±1.58) |
| Hazard ratio | .98 (.64, 1.4) | |
| (95% Confidence Interval) | ||
| Survival (months) | ||
| Median (± 95% CI) | 31.3 (28.3, 38.2) | 31.8 (26.3, 39.8) |
| Mean (± Std error) | 33.7 (±2.03) | 34.3 (±2.04) |
| Hazard ratio | .97 (.69, 1.32) | |
| (95% Confidence Interval) | ||
A randomized controlled trial of standard fractionated radiation (1.8 Gy -2.0 Gy/day for 5 days/week for 5-7 weeks) with or without ETHYOL, administered at 200 mg/m2 as a 3 minute i.v. infusion 15-30 minutes prior to each fraction of radiation, was conducted in 315 patients with head and neck cancer. Patients were required to have at least 75% of both parotid glands in the radiation field. The incidence of Grade 2 or higher acute (90 days or less from start of radiation) and late xerostomia (9-12 months following radiation) as assessed by RTOG Acute and Late Morbidity Scoring Criteria, was significantly reduced in patients receiving ETHYOL (TABLE 4).
TABLE 4
Incidence of Grade 2 or Higher Xerostomia
(RTOG criteria)
| ETHYOL + RT | RT | p-value | |
| Acute (≤90 days from start of radiation) |
51% (75/148) | 78% (120/153) | p<0.0001 |
| Latea (9-12 months post radiation) |
35% (36/103) | 57% (63/111) | p=0.0016 |
| aBased on the number of patients for whom actual data were available. | |||
At one year following radiation, whole saliva collection following radiation showed that more patients given ETHYOL produced >0.1 gm of saliva (72% vs. 49%). In addition, the median saliva production at one year was higher in those patients who received ETHYOL (0.26 gm vs. 0.1 gm). Stimulated saliva collections did not show a difference between treatment arms. These improvements in saliva production were supported by the patients' subjective responses to a questionnaire regarding oral dryness.
In the randomized head and neck cancer study, locoregional control, disease-free survival and overall survival were all comparable in the two treatment groups after one year of follow-up (see TABLE 5).
TABLE 5
Comparison of Principal Efficacy Findings at 1 Year
| ETHYOL + RT | RT | |
| Locoregional Control Ratea | 76.1% | 75.0% |
| Hazard Ratiob | 1.013 | |
| 95% Confidence Interval | (0.671, 1.530) | |
| Disease-Free Survival Ratea | 74.6% | 70.4% |
| Hazard Ratiob | 1.035 | |
| 95% Confidence Interval | (0.702, 1.528) | |
| Overall Survival Ratea | 89.4% | 82.4% |
| Hazard Ratiob | 1.585 | |
| 95% Confidence Interval | (0.961, 2.613) | |
| a1 year rates estimated using Kaplan-Meier method bHazard ratio >1.0 is in favor of the ETHYOL + RT arm |
||
Inform the patient that he or she may experience hypotension after ETHYOL infusion [see ADVERSE REACTIONS]. Advise the patient to inform the prescriber if he or she is receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension [see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].
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 [see WARNINGS AND PRECAUTIONS].
Inform the patient that he or she may experience allergic reactions after ETHYOL infusion [see ADVERSE REACTIONS]. ETHYOL might need to be discontinued for severe acute allergic reactions and the patient receive other treatments [See WARNINGS AND PRECAUTIONS].
Inform the patient that he or she may experience severe nausea and/or vomiting after ETHYOL infusion [see ADVERSE REACTIONS].
Inform the patient that calcium supplements may be necessary if hypocalcemia is identified [see WARNINGS AND PRECAUTIONS]. Blood tests may be needed to identify this, and correct the condition.
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 [see WARNINGS AND PRECAUTIONS and Use In Specific Populations]. Refer to the cisplatin full prescribing information for pregnancy and contraception information.
Advise lactating women not to breastfed during treatment with ETHYOL [see Use In Specific Populations]. Refer to the cisplatin full prescribing information for lactation information.
Advise males of reproductive potential that ETHYOL may impair fertility [see Use In Specific Populations]. Refer to the cisplatin full prescribing information for infertility information.
