Ethyol

What is Ethyol used for?

Ethyol is used to lower the side effects of some chemo drugs or radiation.

This medicine is not approved for use in children. However, the doctor may decide the benefits of taking Ethyol outweigh the risks. If your child has been given Ethyol, ask the doctor for information about the benefits and risks. Talk with the doctor if you have questions about giving Ethyol to your child.

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:

H2N(CH2)3NH(CH2)2S-PO3H2

Amifostine is a white crystalline powder which is freely soluble in water. Its empirical formula is C5H15N2O3PS and it has a molecular weight of 214.22.

ETHYOL is the trihydrate form of amifostine and is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-dose 10 mL vial contains 500 mg of amifostine on the anhydrous basis.

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.

Before taking Ethyol, tell your doctor:

• If you are allergic to Ethyol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Fluid loss or low blood pressure.
• If you are breast-feeding. Do not breast-feed while you take Ethyol.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Ethyol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ethyol?

• Tell all of your health care providers that you take Ethyol. This includes your doctors, nurses, pharmacists, and dentists.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• If you are taking drugs for high blood pressure, talk with your doctor. Your doctor may ask you to skip that drug the day before and on the morning of care.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Check your blood pressure as you have been told.
• You will need to be sure that you are not dehydrated before getting Ethyol. Check with your doctor to see if you need to drink extra fluids before getting Ethyol.
• Other drugs will be given with Ethyol to help avoid side effects.
• A severe and sometimes deadly reaction has happened. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. If you have questions, talk with the doctor.
• If you are 65 or older, use Ethyol with care. You could have more side effects.
• This medicine may affect being able to father a child. Talk with the doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• A pregnancy test will be done to show that you are NOT pregnant before starting Ethyol. If you get pregnant while taking Ethyol, call your doctor right away.

How is Ethyol best taken?

Use Ethyol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of Ethyol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low calcium levels like muscle cramps or spasms, numbness and tingling, or seizures.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Very bad dizziness or passing out.
• Shortness of breath.
• Seizures.
• Chest pain or pressure.
• Fast, slow, or abnormal heartbeat.
• Fever or chills.
• Swollen gland.
• Redness or irritation of the palms of hands or soles of feet.
• Very bad irritation where the shot was given.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Ethyol?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ethyol?

• If you need to store Ethyol at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PAL DISPLAY PANEL – 500 MG