Pronunciation:

a-mi-FOS-teen

Brand Names:

• Ethyol

Dosage Forms:

• Powder for Solution

Classifications:

Therapeutic—

Cytoprotective Agent

Uses of This Medicine:

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.

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

Before Using This Medicine:

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.

Children—

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

Older adults—

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 kidney, liver, or heart disease, which may require caution and an adjustment in the dose in patients receiving amifostine.

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.

Other 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.

Other interactions—

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 This Medicine:

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 This Medicine:

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.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine. If you think you have become pregnant while using this medicine, tell your doctor right away.

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, sweating, or unusual tiredness or weakness.

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

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell 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.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Side Effects of This Medicine:

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

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 with 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

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.