Amifostine Injection
Amifostine is a protective agent given by intravenous infusion to reduce kidney damage from cisplatin chemotherapy in advanced ovarian cancer and to reduce severe dry mouth from radiation therapy in head and neck cancer.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Amifostine Injection: Patient Information Guide
A plain-language walkthrough of Amifostine Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Ethyol (amifostine) is a cytoprotective (cell-protecting) agent approved for two specific uses in cancer care:
- Ethyol injection reduces the cumulative kidney damage (renal toxicity) caused by repeated cisplatin chemotherapy in patients with advanced ovarian cancer
- Ethyol injection reduces the incidence of moderate to severe xerostomia (dry mouth) in patients undergoing post-operative radiation therapy for head and neck cancer, when the radiation port includes a substantial portion of the parotid glands (saliva-producing glands)
- Ethyol is not for use when chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive (primary) radiotherapy, unless as part of a clinical study
⚙️How it works▾
Ethyol is a prodrug — it starts out inactive. Once infused, enzymes (specifically alkaline phosphatase) in normal tissues rapidly convert it into an active protective compound called a free thiol metabolite. This metabolite works in two ways: it binds to and neutralizes the toxic byproducts generated by cisplatin before they can damage kidney cells, and it scavenges reactive oxygen species — unstable molecules that radiation and cisplatin produce and that destroy healthy tissue. Normal tissues activate the drug far more quickly and efficiently than tumor tissue, which is why healthy organs are better protected while the cancer-fighting effects of treatment remain largely intact.
💊How it's taken▾
Ethyol is given exclusively by intravenous (IV) infusion in a clinical setting — always before chemotherapy or radiation on each treatment day. The timing and duration of the infusion differ by use: when protecting the kidneys during cisplatin chemotherapy, the infusion runs over 15 minutes and is started 30 minutes before chemo; when protecting against dry mouth during radiation, the infusion runs over 3 minutes and starts 15–30 minutes before each radiation session.
- Patients must lie flat (supine) during every infusion
- Anti-nausea medication and hydration are given beforehand each time
- Blood pressure is monitored throughout and after the infusion
- Your oncology team sets the schedule — do not adjust or skip doses on your own
🤒Side effects — in detail▾
The most common side effects of Ethyol are nausea, vomiting, and low blood pressure (hypotension) — these occur frequently and can be significant.
- Low blood pressure during or shortly after infusion (very common, especially at the higher chemotherapy dose)
- Nausea and vomiting — often severe; anti-nausea medicines are given to help
- Low calcium levels in the blood (hypocalcemia) — may cause muscle cramps or tingling
- Chills and flushing
- Dizziness or faintness
- Sneezing
Serious reactions — including severe skin blistering, anaphylaxis (a severe allergic reaction), extreme blood pressure drops leading to fainting or heart rhythm changes, and dangerously low calcium — require immediate medical attention. Alert your care team right away if any of these occur.
⚠️Warnings & precautions▾
- Hypotension and cardiovascular events: Blood pressure can drop sharply during the infusion. Severe cases have included fainting, seizures, abnormal heart rhythms, heart attack, and cardiac arrest. Patients must be hydrated, lying flat, and continuously monitored. Blood pressure medications may need to be paused 24 hours before each dose.
- Severe skin reactions: Fatal and life-threatening skin reactions — including Stevens-Johnson syndrome and toxic epidermal necrolysis (severe skin blistering and peeling) — have been reported and can appear weeks after treatment starts. Stop Ethyol immediately if severe skin changes develop.
- Severe allergic reactions (anaphylaxis): Can include throat swelling, difficulty breathing, hives, and chest discomfort. Emergency medications must be available at every infusion.
- Nausea and vomiting: Frequently severe; anti-nausea medicines are required before every infusion, and fluid balance must be watched carefully.
- Low calcium (hypocalcemia): Patients at higher risk (such as those with nephrotic syndrome) need calcium monitoring; supplements may be needed.
- Embryo-fetal toxicity: Ethyol can harm a developing fetus. Pregnancy must be ruled out before starting treatment, and pregnant patients must be clearly informed of the risk.
- Potential interference with cancer treatment: Ethyol may reduce the effectiveness of chemotherapy or radiation in certain settings — it should not be used when curative treatment is the goal, outside of approved indications.
🔀What it interacts with▾
Ethyol has a small but important interaction profile — the main concern is with drugs that lower blood pressure:
- Antihypertensive medications (blood pressure drugs): Combining these with Ethyol significantly increases the risk of dangerous blood pressure drops during infusion. Your care team will typically pause these medications 24 hours before each Ethyol dose; if they cannot be stopped, Ethyol should be avoided at the higher chemotherapy dose.
- Other drugs that can lower blood pressure or cause hypotension: These require close monitoring throughout the infusion period.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to aminothiol compounds: Ethyol is contraindicated — do not use it if you have a known allergy to this class of compounds
- Low blood pressure or dehydration: Ethyol must not be given until these are corrected; always tell your team how you are feeling before each infusion
- Blood pressure medications: Tell your care team about all medications; these may need to be temporarily held before each dose
- Pregnancy: Ethyol can cause fetal harm based on animal studies — pregnancy should be confirmed negative before starting, and the risk must be discussed clearly
- Breastfeeding: Do not breastfeed during treatment; it is unknown if Ethyol or its metabolites pass into breast milk and could harm a nursing infant
- Males of reproductive potential: Animal studies suggest Ethyol may impair male fertility — discuss this with your doctor if relevant
- Children: Safety and effectiveness in pediatric patients have not been established
- Older adults: Should be monitored with extra caution due to the greater likelihood of reduced heart, kidney, or liver function and the presence of other medical conditions or medications
- Risk of low calcium (e.g., nephrotic syndrome): Tell your doctor — calcium levels will need to be monitored and supplements may be required
🚑If you take too much▾
In clinical trials, the highest single dose studied was 1,300 mg/m² — there is no information on doses above this in adults. At higher doses, anxiety and reversible urinary retention (difficulty urinating) were reported. The most likely effect of too much Ethyol is a significant drop in blood pressure, which is managed with IV fluids (normal saline) and supportive care as needed.
📡Pharmacodynamics — effects in the body▾
Ethyol's active thiol metabolite works by selectively accumulating in normal tissues, where it neutralizes the reactive toxic byproducts of cisplatin and scavenges harmful free radicals generated by radiation. Because tumor tissue has lower enzyme activity, poorer blood supply, and a less favorable environment for activating the drug, it takes up far less of the protective metabolite — helping preserve the cancer-killing effects of treatment while shielding healthy organs.
🔬Pharmacokinetics — how your body processes it▾
Ethyol is cleared from the bloodstream extremely rapidly — less than 10% remains in the plasma just 6 minutes after administration, with a distribution half-life of under 1 minute and an elimination half-life of about 8 minutes. It is quickly converted in the body to its active free thiol metabolite, which reaches the bone marrow within 5–8 minutes of IV infusion. Kidney excretion of the parent drug and its metabolites during the first hour after dosing is low. Prior use of dexamethasone or metoclopramide does not affect how the body handles Ethyol.
📦How to store it▾
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) .
📄 Written from Amifostine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Amifostine Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why am I being given this medication on the day of my chemotherapy or radiation — what is it actually doing for me? ▾
Will this medication interfere with my cancer treatment and make it less effective? ▾
What side effects should I expect during or right after the infusion? ▾
Are there any warning signs during or after treatment that I should tell someone about immediately? ▾
I take blood pressure medication every day — do I need to do anything differently on infusion days? ▾
Is it safe to take this if I am pregnant or planning to become pregnant? ▾
Is Amifostine Injection available over the counter? ▾
When was Amifostine Injection first available? ▾
Who makes Amifostine Injection? ▾
💬 Answers drafted from Amifostine Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Amifostine Injection comes
Amifostine Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Ethyol injection is used to reduce cumulative kidney damage in patients with advanced ovarian cancer receiving repeated cisplatin chemotherapy
- Ethyol injection is used to reduce the risk of moderate to severe dry mouth (xerostomia) in patients receiving post-operative radiation therapy for head and neck cancer when the parotid glands are in the radiation field
- Ethyol is given as an intravenous infusion by a healthcare provider before chemotherapy or radiation — not self-administered at home
- Ethyol infusion for chemotherapy use is given over 15 minutes, starting 30 minutes before cisplatin; for radiation use, it is given over 3 minutes, starting 15–30 minutes before radiation therapy
- Ethyol requires patients to remain lying flat (supine) during the infusion, with blood pressure monitored throughout
- Anti-nausea medications and adequate hydration are given before each Ethyol infusion to reduce the risk of vomiting and low blood pressure
📊 Amifostine Injection across the U.S. market
How Amifostine Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Amifostine Injection products
A representative set of FDA-listed product records for Amifostine Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 500 mg/10 mL | Intravenous | Clinigen Limited × 2 listings | NDA | View NDC → |
| 500 mg/10 mL | Intravenous | Legacy Pharma USA Inc. | NDA | View NDC → |
| 500 mg | — | Symbiosis Pharmaceutical Services Limited | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Amifostine Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Amifostine Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Amifostine Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Amifostine Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 4126 1 dose form · 1 strength
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Dose form (SCDF) Injection RxCUI 1721593In current FDA listingsClinical drug / strength (SCD) 500 MGRxCUI 308096
Look up RxCUI 4126 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Amifostine Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Amifostine Injection belongs to the Cytoprotective Agent class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Legacy Pharma USA Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.