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Class: Supportive care

Generic Name: Amifostine (a-mi-FOSS-teen)

Trade Name: Ethyol®

For which conditions is Ethyol approved for? Ethyol is FDA approved to reduce side effects to the kidneys caused by repeated administration of the chemotherapy agent cisplatin (Platinol®) in patients with advanced ovarian cancer. It is also FDA approved to reduce dry mouth caused by radiation therapy following surgery in patients with head and neck cancer.

It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.

What is the mechanism of action? Ethyol belongs to a group of agents called cytoprotectants, which protect normal tissue from some of the side effects caused by some treatments for cancer. Ethyol provides these protective effects after being broken down in the body to specific metabolites. Through chemical reactions, the metabolites from Ethyol deactivate molecules from cisplatin or radiation therapy that cause side effects. The protective metabolites of Ethyol tend to accumulate more in healthy cells than in cancerous cells, so that cancer cells are not protected from the anti-cancer effects of treatment.

How is Ethyol typically given (administered)? Ethyol is typically administered intravenously (into a vein). Ethyol is given approximately 15 to 30 minutes prior to treatment with chemotherapy or radiation therapy. Because low blood pressure may occur during Ethyol administration, patients typically receive the drug while lying down, have their blood pressure frequently monitored, and may receive intraveneous fluid to help maintain their blood pressure. Uncommonly, patients may experience other side effects during the administration of Ethyol. These side effects include fever, chills, difficulty breathing, low levels of oxygen in the blood, chest tightness, skin abnormalities, inflammation of the larynx, or heart attack. Patients should inform their healthcare provider if they are experiencing lightheadedness, fever, chills, difficulty breathing, chest tightness or pain, difficulty speaking, or skin abnormalities during the administration of Ethyol.

How are patients typically monitored? Patients will usually have their blood pressure monitored frequently – approximately every 5 minutes – during the administration of Ethyol and periodically after administration. Patients may also be monitored for calcium levels in their blood.

What are the common (occur in 30% or more of patients) side effects of treatment with Ethyol?

• Low blood pressure
• Nausea and vomiting
• Flushing

(All side effects occur during administration.)

What are the less common (occur in 10% to 29% of patients) side effects of treatment with Ethyol?

• Dizziness
• Fatigue
• Somnolence
• Chills
• Hiccups
• Redness of the face or neck
• Sneezing
(All side effects occur during administration.)

This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

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Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

• Pay careful attention to the physician’s instructions and inform the physician of any side effects.
• Wear sunscreen and protective clothing and try to minimize sun exposure.
• Drink plenty of water or liquid prior to receiving Ethyol.
• Eat small meals frequently to help alleviate nausea.
• Maintain adequate rest and nutrition.

Are there any special precautions patients should be aware of before starting treatment?

• Patients should tell their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
• It is important that patients inform their physician of any pre-existing conditions (chicken pox, infection, heart disease, kidney disease, liver disease, lung disease, thyroid disease, etc.) as they may worsen with this drug.
• Patients should inform their physician if they have ever had convulsions or seizures.
• Patients should inform their physician about any other medication they are taking (whether prescription or over the counter, including vitamins, herbs, etc.) as they may interfere with treatment.
• Patients should check with their physician before starting any new drug or nutritional supplement.
• Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
• Patients should inform their physician if they are taking antihypertensive medication (medication to treat high blood pressure) before receiving Ethyol because Ethyol causes low blood pressure.

When should patients notify their physician? (If any of these problems occur during infusion of Ethyol)

• Difficulty breathing
• Skin reactions
• Lightheadedness, dizziness
• Prolonged or severe nausea or vomiting
• Chest pain or chest tightness
• Fever
• Chills
• Tremors or shaking

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.



The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.