Ethyol Amifostine 500 mg/10mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cytoprotective Agent class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Amifostine is used to protect the kidneys from harmful effects of the chemotherapy drug cisplatin in patients that receive this medication for the treatment of ovarian cancer. Amifostine is also used to decrease dryness in the mouth caused by radiation treatment after surgery for head and neck cancer. Amifostine is in a class of medications called cytoprotectants. It works by protecting against the harmful effects of chemotherapy medications and radiation treatment.
Read the full MedlinePlus article ↗- Ethyol is a protector, not a cancer treatment itself. It's given right before your chemotherapy or radiation to help shield your healthy tissues — specifically your kidneys if you'...
- Why am I being given this medication on the day of my chemotherapy or radiation — what is it actually doing for me?
- That's a really important question, and your oncology team has thought about it carefully. Ethyol is designed to protect normal tissue more than tumor tissue, so for the approved u...
- Will this medication interfere with my cancer treatment and make it less effective?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Ethyol 500 mg/10mLthis 83107-0030-02 | Legacy | 3 vials | — | — | FDA listed | — |
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⏳ Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83107-0030-02 You're viewing this | 3 VIAL, SINGLE-DOSE in 1 CARTON (83107-030-02) / 10 mL in 1 VIAL, SINGLE-DOSE (83107-030-01) | 2026-03-16 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 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 )
1.1Reduction 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) ] .
1.2Reduction 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.
⏱️ 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 )
2.1Important 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.
2.2Recommended 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.
2.3Recommended 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).
2.4Dose 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 .
2.5Preparation 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 u…
💊 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.
⛔ 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 )
⚠️ 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.
5.1Effectiveness 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.
5.2Effectiveness 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.
5.3Hypotension 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 no…
🤒 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 .
6.1Clinical 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) [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.
6.2Post-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 [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…
🔄 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 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS - – Advise not to breastfeed. ( 8.2 ) See 17 for PATIENT COUNSELING INFORMAITON.
8.1Pregnancy 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 (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.
8.2Lactation 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.
8.3Females 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 [see Nonclinical Toxicology (13.1) ] .
8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.
8.5Geriatric 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.
🤰 Pregnancy ▾
8.1Pregnancy 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 (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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric 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.
🆘 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) ] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.3Pharmacokinetics 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.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
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) ] .
📋 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