{"id":"amifostine","rwe":[{"pmid":"41819597","year":"2026","title":"Underscoring the Effects of Proton Radiation on Neuronal Function in 2D and 3D In Vitro Cortical Tissue Models.","finding":"","journal":"Radiation research","studyType":"Clinical Study"},{"pmid":"41701295","year":"2026","title":"Propionate-engineered probiotics reduce radiation-induced intestinal damage.","finding":"","journal":"Bioresources and bioprocessing","studyType":"Clinical Study"},{"pmid":"41675677","year":"2026","title":"Radioprotectant-loaded visualizable cationic radioactive microspheres: Reduced hepatic tissue damage and intra/postoperative imaging during TARE.","finding":"","journal":"Materials today. Bio","studyType":"Clinical Study"},{"pmid":"41622096","year":"2026","title":"Clinical evidence for managing radiotherapy-induced oral mucositis and xerostomia in head and neck cancer patients: a review of Phase III-IV trials.","finding":"","journal":"International journal of oral and maxillofacial surgery","studyType":"Clinical Study"},{"pmid":"41551880","year":"2026","title":"Functionalized hydrogel sequentially deliver tannic acid and bioactive probiotics for radiation-induced skin injury.","finding":"","journal":"Materials today. Bio","studyType":"Clinical Study"}],"_fda":{"id":"4c20479c-d75a-a0c7-e063-6394a90a9e59","set_id":"a17563f2-d231-4385-bc94-0217be78b89d","openfda":{"unii":["M487QF2F4V"],"route":["INTRAVENOUS"],"rxcui":["308096","1803018"],"spl_id":["4c20479c-d75a-a0c7-e063-6394a90a9e59"],"brand_name":["Ethyol"],"spl_set_id":["a17563f2-d231-4385-bc94-0217be78b89d"],"package_ndc":["83107-030-01","83107-030-02"],"product_ndc":["83107-030"],"generic_name":["AMIFOSTINE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["AMIFOSTINE"],"manufacturer_name":["Legacy Pharma USA Inc."],"application_number":["NDA020221"],"is_original_packager":[true]},"version":"2","pregnancy":["8.1 Pregnancy 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 (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. 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."],"overdosage":["10 OVERDOSAGE In clinical trials, the maximum single dose of ETHYOL was 1300 mg/m 2 . 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 (5.3) ] ."],"references":["15 REFERENCES “OSHA Hazardous Drugs.\" OSHA, http://www.osha.gov/SLTC/hazardousdrugs/index.html"],"description":["11 DESCRIPTION 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 5 H 15 N 2 O 3 PS 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-dose 10 mL vial contains 500 mg of amifostine on the anhydrous basis. structure"],"how_supplied":["16 HOW 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 [see References (15) ] ."],"geriatric_use":["8.5 Geriatric 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."],"pediatric_use":["8.4 Pediatric Use The safety and effectiveness in pediatric patients have not been established."],"effective_time":"20260303","clinical_studies":["14 CLINICAL STUDIES 14.1 Reduction of Cumulative Renal Toxicity with Chemotherapy A randomized controlled trial (WR-1) compared six cycles of cyclophosphamide 1000 mg/m 2 , and cisplatin 100 mg/m 2 with or without ETHYOL pretreatment at 910 mg/m 2 , in two successive cohorts with a total of 242 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. Table 3: Patients with ≥40% Reduction in Calculated Creatinine Clearance a 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 a Creatinine clearance values were calculated using the Cockcroft-Gault formula. Table 4: Patients with Increasing Grades of Hypomagnesemia NCI-CTC Grade a : (mEq/L) 0 1 2 3 4 p-value b >1.4 ≤1.4->1.1 ≤1.1->0.8 ≤0.8->0.5 ≤0.5 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 a NCI toxicity grades of serum magnesium levels for each patient's last cycle of therapy. b Based on 2-sided Mantel-Haenszel Chi-Square statistic. Exploratory subgroup analyses suggested that the effect of ETHYOL was consistent in patients with increased risks for nephrotoxicity (i.e., nephrotoxic antibiotics, preexisting diabetes, or hypertension) compared to patients who lacked these risks. The effects of ETHYOL in reducing the cumulative renal toxicity of cisplatin in the randomized ovarian cancer study are shown in Tables 3 and 4. 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. Table 5 summarizes the efficacy findings of the WR-1 ovarian cancer study. Table 5: Efficacy Results from the WR-1 Study 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 (95% Confidence Interval) .98 (.64, 1.4) 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 (95% Confidence Interval) .97 (.69, 1.32) 14.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck A randomized controlled trial (WR-38) 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/m 2 as a 3 minute intravenous 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 6). Table 6: 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 Late a (9-12 months post radiation) 35% (36/103) 57% (63/111) p=0.0016 a Based 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 7). Table 7: Efficacy Results at 1 Year from the WR-38 Study ETHYOL + RT RT Locoregional Control Rate a Hazard Ratio b 95% Confidence Interval 76.1% 75.0% 1.013 (0.671, 1.530) Disease-Free Survival Rate a Hazard Ratio b 95% Confidence Interval 74.6% 70.4% 1.035 (0.702, 1.528) Overall Survival Rate a Hazard Ratio b 95% Confidence Interval 89.4% 82.4% 1.585 (0.961, 2.613) a 1 year rates estimated using Kaplan-Meier method b Hazard ratio >1.0 is in favor of the ETHYOL + RT arm"],"pharmacokinetics":["12.3 Pharmacokinetics 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/m 2 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."],"adverse_reactions":["6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: – Hypotension and Cardiovascular Events [see Warnings and Precautions (5.3) ] – Severe Cutaneous Reactions [see Warnings and Precautions (5.4) ] – Hypersensitivity [see Warnings and Precautions (5.5) ] – Nausea and Vomiting [see Warnings and Precautions (5.6) ] – Hypocalcemia [see Warnings and Precautions (5.7) ] Most common adverse reactions are hypotension, nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Legacy Pharma Inc. at 1-800-727-7151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical 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) [see Clinical Studies (14) ] . 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. Table 2: Incidence of Common Adverse Reactions in Patients Receiving ETHYOL Ovarian Cancer (WR-1 Trial) 910 mg/m 2 Head and Neck Cancer (WR-38 Trial) 200 mg/m 2 Per Patient Per Infusion Per Patient Per Infusion Nausea/Vomiting ≥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%) Hypotension ≥Grade 3 10/122 (8%) 4/150 (3%) All Grades 75/122 (62%) 159/592 (27%) 22/150 (15%) 46/4314 (1%) 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. 6.2 Post-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 [see Warnings and Precautions (5.3) ] – Severe Cutaneous Reactions [see Warnings and Precautions (5.4) ] – Hypersensitivity [see Warnings and Precautions (5.5) ] 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."],"contraindications":["4 CONTRAINDICATIONS ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds. ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds. ( 4 )"],"drug_interactions":["7 DRUG INTERACTIONS Closely monitor patients receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension. – Closely monitor patients receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension. ( 7 )"],"mechanism_of_action":["12.1 Mechanism of Action 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_pharmacology":["12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action 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. 12.3 Pharmacokinetics 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/m 2 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."],"indications_and_usage":["1 INDICATIONS AND USAGE ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of 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. ( 1.2 ) Limitation of Use Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy. ( 1 , 5.1 , 5.2 ) 1.1 Reduction of Cumulative Renal Toxicity with Chemotherapy 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 (14.1) ] . 1.2 Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck 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 (14.2) ] . Limitation of Use Do not use ETHYOL in other settings where chemotherapy can produce a significant survival benefit or cure [see Warnings and Precautions (5.1) ] , or in patients receiving definitive radiotherapy [see Warnings and Precautions (5.2) ] , except in the context of a clinical study."],"warnings_and_cautions":["5 WARNINGS AND PRECAUTIONS – Hypotension and Cardiovascular Events: Patients who are hypotensive or dehydrated should not receive ETHYOL. If interruption of antihypertensive therapy is possible, interrupt antihypertensive therapy 24 hours prior to ETHYOL administration. Monitor blood pressure during infusion; interrupt and restart infusion if decrease in systolic blood pressure is observed. Do not administer ETHYOL to hypotensive patients who are taking antihypertensive therapy that cannot be stopped for 24 hours prior to ETHYOL administration. ( 5.3 ) – Severe Cutaneous Reactions: Monitor patients prior to, during, and weeks after administration for severe cutaneous reactions. Discontinue for cutaneous reactions or lesions appearing outside of the injection site/radiation port or on the palms or soles. ( 5.4 ) – Hypersensitivity: Discontinue for severe acute allergic reactions. Administer treatment for serious allergic events. ( 5.5 ) – Nausea and Vomiting: Administer antiemetic medication prior to and in conjunction with ETHYOL. Monitor fluid balance when administered with highly emetogenic chemotherapy. ( 5.6 ) – Hypocalcemia: Monitor serum calcium levels in patients at risk of hypocalcemia. If necessary, administer calcium supplements. ( 5.7 ) – Embryo-Fetal Toxicity: ETHYOL can cause fetal harm. Advise patients of the potential risk to a fetus ( 5.8 , 8.1 , 8.3 ). Also, refer to the cisplatin full prescribing information for pregnancy and contraception information. 5.1 Effectiveness of the Chemotherapy Regimen 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. 5.2 Effectiveness of Radiotherapy 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. 5.3 Hypotension and Cardiovascular Events 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/m 2 , 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/m 2 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/m 2 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 (2.1) ] . 5.4 Severe Cutaneous Reactions 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 (6) ] . 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. 5.5 Hypersensitivity 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. 5.6 Nausea and Vomiting 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/m 2 , 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/m 2 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 (2.1) ] . When ETHYOL is administered with highly emetogenic chemotherapy, closely monitor the fluid balance of the patient. 5.7 Hypocalcemia 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. 5.8 Embryo-Fetal Toxicity 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."],"clinical_studies_table":["
Table 3: Patients with ≥40% Reduction in Calculated Creatinine Clearance a
ETHYOL + CPCPp-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
","
Table 4: Patients with Increasing Grades of Hypomagnesemia
NCI-CTCGrade a: (mEq/L) 0 1 2 3 4p-value b
>1.4≤1.4->1.1≤1.1->0.8≤0.8->0.5≤0.5
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
","
Table 5: Efficacy Results from the WR-1 Study
ETHYOL + CPCP
Complete pathologic tumorresponse 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 (95% Confidence Interval).98 (.64, 1.4)
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 (95% Confidence Interval) .97 (.69, 1.32)
","
Table 6: Incidence of Grade 2 or Higher Xerostomia (RTOG criteria)
ETHYOL + RTRTp-value
Acute(≤90 days from start of radiation) 51% (75/148) 78% (120/153) p<0.0001
Late a(9-12 months postradiation) 35% (36/103) 57% (63/111) p=0.0016
","
Table 7: Efficacy Results at 1 Year from the WR-38 Study
ETHYOL + RTRT
Locoregional Control Rate aHazard Ratio b95% Confidence Interval 76.1% 75.0%
1.013
(0.671, 1.530)
Disease-Free Survival Rate aHazard Ratio b95% Confidence Interval 74.6% 70.4%
1.035
(0.702, 1.528)
Overall Survival Rate aHazard Ratio b95% Confidence Interval 89.4% 82.4%
1.585
(0.961, 2.613)
"],"nonclinical_toxicology":["13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 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)."],"adverse_reactions_table":["
Table 2: Incidence of Common Adverse Reactions in Patients Receiving ETHYOL
Ovarian Cancer (WR-1 Trial) 910 mg/m 2Head and Neck Cancer (WR-38 Trial) 200 mg/m 2
Per PatientPer InfusionPer PatientPer Infusion
Nausea/Vomiting
≥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%)
Hypotension
≥Grade 3 10/122 (8%) 4/150 (3%)
All Grades 75/122 (62%) 159/592 (27%) 22/150 (15%) 46/4314 (1%)
"],"spl_unclassified_section":["17 PATIENT COUNSELING INFORMATION Hypotension and Cardiovascular Events Inform the patient that he or she may experience hypotension after ETHYOL infusion [see Adverse Reactions (6.1) ] . 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 (5.3) , Drug Interactions (7) ] . 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 [see Warnings and Precautions (5.4) ] . Hypersensitivity Inform the patient that he or she may experience allergic reactions after ETHYOL infusion [see Adverse Reactions (6.1) ] . ETHYOL might need to be discontinued for severe acute allergic reactions and the patient receive other treatments [See Warnings and Precautions (5.5) ] . Nausea and Vomiting Inform the patient that he or she may experience severe nausea and/or vomiting after ETHYOL infusion [see Adverse Reactions (6.1) ] . Hypocalcemia Inform the patient that calcium supplements may be necessary if hypocalcemia is identified [see Warnings and Precautions (5.7) ] . Blood tests may be needed to identify this, and correct the condition. 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 [see Warnings and Precautions (5.8) a nd Use in Specific Populations (8.1) ] . Refer to the cisplatin full prescribing information for pregnancy and contraception information. Lactation Advise lactating women not to breastfed during treatment with ETHYOL [see Use in Specific Populations (8.2) ]. Refer to the cisplatin full prescribing information for lactation information. Infertility Advise males of reproductive potential that ETHYOL may impair fertility [see Use in Specific Populations (8.3) ] . Refer to the cisplatin full prescribing information for infertility information. 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 000000 logo"],"dosage_and_administration":["2 DOSAGE AND ADMINISTRATION – For reduction of cumulative renal toxicity with chemotherapy, the recommended starting dose is 910 mg/m 2 administered once daily as a 15-minute intravenous infusion, starting 30 minutes prior to chemotherapy. ( 2.1 ) – For reduction of moderate to severe xerostomia from radiation of the head and neck, the recommended dose is 200 mg/m 2 administered once daily as a 3-minute intravenous infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy). ( 2.2 ) 2.1 Important Administration Instructions Hydration and Premedication Prior to ETHYOL infusion, verify that patients are adequately hydrated and correct existing dehydration if clinically indicated. When administering ETHYOL at the 910 mg/m 2 dose, antiemetic medications, including intravenous dexamethasone 20 mg and a serotonin 5HT 3 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/m 2 dose, it is recommended that antiemetic medication be administered prior to ETHYOL administration. Oral 5HT 3 receptor antagonists, alone or in combination with other antiemetics are recommended in the radiotherapy setting. Supine Position and Blood Pressure Monitoring Patients should be kept in a supine position during the ETHYOL infusion. When administering ETHYOL at the 910 mg/m 2 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/m 2 dose, monitor blood pressure before and at the end of the infusion, and thereafter as clinically indicated. 2.2 Recommended Dose for Reduction of Cumulative Renal Toxicity with Chemotherapy The recommended starting dose of ETHYOL is 910 mg/m 2 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. 2.3 Recommended Dose for Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck The recommended dose of ETHYOL is 200 mg/m 2 administered as a 3-minute intravenous infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy). 2.4 Dose Modifications for Infusion-Related Reactions 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 Pressure Baseline Systolic Blood Pressure(mm Hg) <100 100-119 120-139 140-179 ≥180 Decrease in systolic blood pressure during infusion of ETHYOL (mm Hg) 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/m 2 dose, if the full dose of ETHYOL cannot be administered, the dose of ETHYOL for subsequent chemotherapy cycles should be 740 mg/m 2 . 2.5 Preparation Reconstitution 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 (15) ]. 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/mL 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). Dilution Further dilute to ETHYOL with 0.9% Sodium Chloride Injection, USP to a final concentration of 5 mg/mL to 40 mg/mL before administration. ETHYOL prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL 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. 2.6 Incompatibilities 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."],"spl_product_data_elements":["Ethyol Amifostine AMIFOSTINE AMIFOSTINE ANHYDROUS"],"dosage_forms_and_strengths":["3 DOSAGE 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. – For injection: sterile lyophilized powder in 10 mL single-dose vials. – Each vial contains 500 mg of amifostine on the anhydrous basis."],"use_in_specific_populations":["8 USE IN SPECIFIC POPULATIONS - – Advise not to breastfeed. ( 8.2 ) See 17 for PATIENT COUNSELING INFORMAITON. 8.1 Pregnancy 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 (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. 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. 8.2 Lactation 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. 8.3 Females 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 [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use The safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric 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."],"dosage_and_administration_table":["
Table 1: Interrupting ETHYOL Infusion Due to Decreases in Systolic Blood Pressure
Baseline Systolic Blood Pressure(mm Hg)
<100100-119120-139140-179≥180
Decrease in systolic blood pressure during infusion of ETHYOL (mm Hg) 20 25 30 40 50
"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL NDC 83107-030-02 Rx only ETHYOL ® (amifostine) for Injection 500 mg per vial For Intravenous Use Sterile 3 VIALS LEGACY PHARMA label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 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)."]},"tags":[{"label":"amifostine","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"D(3) dopamine receptor","category":"target"},{"label":"DRD3","category":"gene"},{"label":"ALPL","category":"gene"},{"label":"V03AF05","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Injection","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Mature","category":"status"},{"label":"Prevention of Cancer Chemotherapy-Induced Renal Impairment","category":"indication"},{"label":"Prevention of Xerostomia Secondary to Radiation Therapy","category":"indication"},{"label":"Cosette","category":"company"},{"label":"Approved 1990s","category":"decade"},{"label":"Protective Agents","category":"pharmacology"},{"label":"Radiation-Protective Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":171.432,"date":"","count":72,"signal":"Mucosal inflammation","source":"DrugCentral FAERS","actionTaken":"Reported 72 times (LLR=171)"},{"llr":157.012,"date":"","count":37,"signal":"Laryngeal pain","source":"DrugCentral FAERS","actionTaken":"Reported 37 times (LLR=157)"},{"llr":136.828,"date":"","count":138,"signal":"Pyrexia","source":"DrugCentral FAERS","actionTaken":"Reported 138 times (LLR=137)"},{"llr":96.973,"date":"","count":63,"signal":"Chills","source":"DrugCentral FAERS","actionTaken":"Reported 63 times (LLR=97)"},{"llr":95.225,"date":"","count":91,"signal":"Hypotension","source":"DrugCentral FAERS","actionTaken":"Reported 91 times (LLR=95)"},{"llr":73.397,"date":"","count":100,"signal":"Rash","source":"DrugCentral FAERS","actionTaken":"Reported 100 times (LLR=73)"},{"llr":69.148,"date":"","count":121,"signal":"Nausea","source":"DrugCentral FAERS","actionTaken":"Reported 121 times (LLR=69)"},{"llr":67.872,"date":"","count":60,"signal":"Dehydration","source":"DrugCentral FAERS","actionTaken":"Reported 60 times (LLR=68)"},{"llr":62.942,"date":"","count":94,"signal":"Vomiting","source":"DrugCentral FAERS","actionTaken":"Reported 94 times (LLR=63)"},{"llr":58.923,"date":"","count":16,"signal":"Soft tissue disorder","source":"DrugCentral FAERS","actionTaken":"Reported 16 times (LLR=59)"},{"llr":57.748,"date":"","count":35,"signal":"Injection site erythema","source":"DrugCentral FAERS","actionTaken":"Reported 35 times (LLR=58)"},{"llr":57.729,"date":"","count":13,"signal":"Radiation skin injury","source":"DrugCentral FAERS","actionTaken":"Reported 13 times (LLR=58)"},{"llr":57.472,"date":"","count":23,"signal":"Rash papular","source":"DrugCentral FAERS","actionTaken":"Reported 23 times (LLR=57)"},{"llr":53.228,"date":"","count":30,"signal":"Injection site reaction","source":"DrugCentral FAERS","actionTaken":"Reported 30 times (LLR=53)"},{"llr":49.932,"date":"","count":20,"signal":"Injection site rash","source":"DrugCentral FAERS","actionTaken":"Reported 20 times (LLR=50)"}],"commonSideEffects":[{"effect":"Nausea/Vomiting ≥Grade 3","drugRate":"30%","_validated":true,"placeboRate":""},{"effect":"Nausea/Vomiting All Grades","drugRate":"96%","_validated":true,"placeboRate":""},{"effect":"Hypotension ≥Grade 3","drugRate":"8%","_validated":true,"placeboRate":""},{"effect":"Hypotension All Grades","drugRate":"62%","_validated":true,"placeboRate":""},{"effect":"Nausea/Vomiting ≥Grade 3","drugRate":"8%","_validated":true,"placeboRate":""},{"effect":"Nausea/Vomiting All Grades","drugRate":"53%","_validated":true,"placeboRate":""}],"contraindications":["ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds."],"specialPopulations":{"Lactation":"There are no data on the presence of ETHYOL in human milk, the effects on the breastfed infant, or the effects on milk production. However, because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from ETHYOL, advise not to breastfeed.","Pregnancy":"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 pregnant woman. There are no available data on ETHYOL use in pregnant women to evaluate for 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 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."},"discontinuationRates":[{"trial":"WR-38 study","drugArm":"17%","placeboArm":"","commonReason":"adverse reactions"}]},"trials":[],"aliases":[],"company":"Cosette","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=AMIFOSTINE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:43:51.949946+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:43:57.550575+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMIFOSTINE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:43:57.848062+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:43:50.830930+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:43:50.830949+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1006/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:43:58.555770+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: – Hypotension and Cardiovascular Events [see Warnings and Precautions (5.3) ] – Severe Cutaneous Reactions [see Warnings and Precautions (5.4) ] – Hypersensitivity [see Warnings and Precautions (5.5) ] – Nausea and Vomiting [see Warnings and Precautions (5.6) ] – Hypocalcemia [see Warnings and Precautions (5.7) ] Most common adverse reactions are hypotension, nausea and ","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:14.903241+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:44:17.415011+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"NDA020221","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:43:50.830953+00:00"}},"allNames":"ethyol","offLabel":[],"synonyms":["amifostine","aminopropylaminoethyl thiophosphate","ethiofos","gammaphos","WR-2721","amifostine trihydrate"],"timeline":[{"date":"1995-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from CLINIGEN HLTHCARE to Cosette"},{"date":"1995-12-08","type":"positive","source":"DrugCentral","milestone":"FDA approval (Clinigen Hlthcare)"},{"date":"2017-07-17","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 2 manufacturers approved"}],"aiSummary":"Ethyol (AMIFOSTINE) is a small molecule drug developed by Clinigen Healthcare and currently owned by Cosette. It targets the D(3) dopamine receptor and is classified as an amifostine. Ethyol is FDA-approved for preventing cancer chemotherapy-induced renal impairment and xerostomia secondary to radiation therapy. It has a short half-life of 0.15 hours and high bioavailability of 99%. Ethyol is off-patent with multiple generic manufacturers.","brandName":"Ethyol","ecosystem":[{"indication":"Prevention of Cancer Chemotherapy-Induced Renal Impairment","otherDrugs":[],"globalPrevalence":null},{"indication":"Prevention of Xerostomia Secondary to Radiation Therapy","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"D(3) dopamine receptor","novelty":"Follow-on","targets":[{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor"},{"gene":"ALPL","source":"DrugCentral","target":"Alkaline phosphatase, tissue-nonspecific isozyme","protein":"Alkaline phosphatase, tissue-nonspecific isozyme"}],"modality":"Small Molecule","drugClass":"amifostine","explanation":"ETHYOL is prodrug that is dephosphorylated by alkaline phosphatase in tissues to 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 more rapid generation of the active thiol metabolite as well as 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.","oneSentence":"Ethyol works by protecting the kidneys and salivary glands from damage caused by chemotherapy and radiation.","technicalDetail":"Ethyol exerts its protective effects by scavenging free radicals and chelating metals, thereby reducing oxidative stress and inflammation in the kidneys and salivary glands.","_target_confidence":0.5},"commercial":{"launchDate":"1995","_launchSource":"DrugCentral (FDA 1995-12-08, CLINIGEN HLTHCARE)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/156","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=AMIFOSTINE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=AMIFOSTINE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T08:40:39.135885","_validation":{"fieldsValidated":1,"lastValidatedAt":"2026-04-20T03:44:18.322082+00:00","fieldsConflicting":1,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"mesna","drugSlug":"mesna","fdaApproval":"1988-12-30","genericCount":9,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"dexrazoxane","drugSlug":"dexrazoxane","fdaApproval":"1995-05-26","genericCount":4,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"leucovorin","drugSlug":"leucovorin","fdaApproval":"1952-06-20","patentExpiry":"Dec 23, 2044","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"levofolinic acid","drugSlug":"levofolinic-acid","fdaApproval":"2008-03-07","relationship":"same-class"},{"drugName":"rasburicase","drugSlug":"rasburicase","fdaApproval":"2002-07-12","relationship":"same-class"},{"drugName":"palifermin","drugSlug":"palifermin","fdaApproval":"2004-12-15","relationship":"same-class"},{"drugName":"glucarpidase","drugSlug":"glucarpidase","fdaApproval":"2012-01-17","relationship":"same-class"},{"drugName":"arginine","drugSlug":"arginine","fdaApproval":"1973-02-28","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"lysine","drugSlug":"lysine","fdaApproval":"","relationship":"same-class"},{"drugName":"trilaciclib","drugSlug":"trilaciclib","fdaApproval":"2021-02-12","patentExpiry":"Oct 25, 2031","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"amifostine","indications":{"approved":[{"name":"Prevention of Cancer Chemotherapy-Induced Renal Impairment","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":{"age":"advanced ovarian cancer patients","stage":"advanced ovarian cancer","prior treatment":"repeated administration of cisplatin"}},{"name":"Prevention of Xerostomia Secondary to Radiation Therapy","source":"DrugCentral","snomedId":"","regulator":"FDA","eligibility":{"age":"patients undergoing post-operative radiation treatment for head and neck cancer","stage":"head and neck cancer","radiation port":"substantial portion of the parotid glands","prior treatment":"post-operative radiation treatment"}}],"offLabel":[{"name":"Chemotherapy-induced neutropenia","source":"DrugCentral","drugName":"AMIFOSTINE"},{"name":"Drug-induced mucositis","source":"DrugCentral","drugName":"AMIFOSTINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Myelodysplastic syndrome","source":"DrugCentral","drugName":"AMIFOSTINE","evidenceCount":0,"evidenceLevel":"emerging"},{"name":"Prevention of Chemotherapy-Induced Neurotoxicity","source":"DrugCentral","drugName":"AMIFOSTINE","evidenceCount":7,"evidenceLevel":"emerging"},{"name":"Prevention of Radiation Therapy-Induced Mucositis","source":"DrugCentral","drugName":"AMIFOSTINE","evidenceCount":4,"evidenceLevel":"emerging"}],"pipeline":[]},"currentOwner":"Cosette","drugCategory":"mature","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"mesna","brandName":"mesna","genericName":"mesna","approvalYear":"1988","relationship":"same-class"},{"drugId":"dexrazoxane","brandName":"dexrazoxane","genericName":"dexrazoxane","approvalYear":"1995","relationship":"same-class"},{"drugId":"leucovorin","brandName":"leucovorin","genericName":"leucovorin","approvalYear":"1952","relationship":"same-class"},{"drugId":"levofolinic-acid","brandName":"levofolinic acid","genericName":"levofolinic acid","approvalYear":"2008","relationship":"same-class"},{"drugId":"rasburicase","brandName":"rasburicase","genericName":"rasburicase","approvalYear":"2002","relationship":"same-class"},{"drugId":"palifermin","brandName":"palifermin","genericName":"palifermin","approvalYear":"2004","relationship":"same-class"},{"drugId":"glucarpidase","brandName":"glucarpidase","genericName":"glucarpidase","approvalYear":"2012","relationship":"same-class"},{"drugId":"arginine","brandName":"arginine","genericName":"arginine","approvalYear":"1973","relationship":"same-class"},{"drugId":"lysine","brandName":"lysine","genericName":"lysine","approvalYear":"","relationship":"same-class"},{"drugId":"trilaciclib","brandName":"trilaciclib","genericName":"trilaciclib","approvalYear":"2021","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT07157033","phase":"PHASE1,PHASE2","title":"A Phase 1 Study to Evaluate Safety and Efficacy of XER-001 (Amifostine for Nasoduodenal Delivery) in Combination With 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