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Ethyol (Intravenous)

Generic Name: amifostine (Intravenous route)

a-mi-FOS-teen

Commonly used brand name(s)

In the U.S.

  • Ethyol

Available Dosage Forms:

  • Powder for Solution

Therapeutic Class: Cytoprotective Agent

Uses For Ethyol

Amifostine is used to help prevent or lessen some of the side effects of cisplatin (a cancer medicine) or radiation therapy on the kidneys and salivary glands.

Amifostine is to be given only by or under the immediate supervision of your doctor.

Before Using Ethyol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Use of amifostine injection in children is not recommended. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of amifostine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart disease, which may require an adjustment of dose in patients receiving amifostine.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Congestive heart failure or
  • Heart attack, history of or
  • Heart disease or
  • Heart rhythm problems or
  • Kidney disease or
  • Stroke, history of or
  • Transient ischemic attacks (TIA or mini-stroke), history of—Use with caution. May cause side effects to become worse.
  • Dehydration or
  • Hypotension (low blood pressure)—Should not be used in patients with these conditions.

Proper Use of Ethyol

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed into one of your veins.

Amifostine injection is given before cisplatin therapy or radiation therapy. It must be injected slowly, so your IV tube will need to stay in place for at least 15 minutes before cisplatin treatment or at least 3 minutes before radiation therapy.

You may receive other medicines to help prevent nausea and vomiting. You may also be given calcium supplements if needed.

Drink plenty of fluids during the 24 hours before receiving amifostine.

Precautions While Using Ethyol

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Low blood pressure (hypotension) may occur with this medicine. Check with your doctor right away if you have the following symptoms: blurred vision, confusion, severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly, sweating, or unusual tiredness or weakness.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are receiving this medicine.

This medicine may cause a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

This medicine may cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

This medicine may cause hypocalcemia (low calcium in the blood). Check with your doctor if you have stomach cramps, confusion, convulsions, trouble breathing, irregular heartbeat, mood or mental changes, muscle cramps in the hands, arms, feet, legs, or face, or numbness and tingling around the mouth, fingertips, or feet.

Ethyol Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Blurred vision
  • confusion
  • dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
  • fainting or loss of consciousness
  • fast or irregular breathing
  • itching
  • nausea, vomiting
  • red, scaly, swollen, or peeling areas of the skin
  • skin rash
  • sweating
  • swelling of the eyes or eyelids
  • tightness in the chest
  • trouble with breathing
  • unusual tiredness or weakness
Rare
  • Blistering, peeling, or loosening of the skin
  • burning or tingling sensation
  • chills
  • cough
  • cracks in the skin
  • diarrhea
  • fast, slow, or irregular heartbeat or pulse
  • fever
  • joint or muscle pain
  • loss of bladder control
  • loss of heat from the body
  • muscle cramps in the hands, arms, feet, legs, or face
  • muscle spasm or jerking of all extremities
  • no blood pressure or pulse
  • numbness and tingling around the mouth, fingertips, or feet
  • palpitations
  • red irritated eyes
  • red skin lesions, often with a purple center
  • seizures
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomach cramps
  • stopping of the heart
  • sudden loss of consciousness
  • tremor
Incidence not known
  • Bloody urine
  • decreased frequency or amount of urine
  • difficulty in swallowing
  • hives or welts
  • hoarseness
  • increased blood pressure
  • increased thirst
  • lower back or side pain
  • loss of appetite
  • pain or discomfort in the arms, jaw, back, or neck
  • slow or irregular breathing
  • swelling of the face, fingers, or lower legs
  • weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common or rare
  • Feeling unusually warm or cold
  • flushing or redness of the face or neck
  • headache
  • hiccups
  • nervousness
  • pounding in the ears
  • sleepiness (severe)
  • sneezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Side Effects (complete list)

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