In the U.S.—

In Canada—

• Antineoplastic adjunct
• cytoprotective agent

Amifostine (am-i-FOS-teen) is used to help prevent or lessen some side effects caused by other medicines or radiation therapy that are used to treat cancer.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Parenteral
• Injection (U.S. and Canada)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to amifostine.

Pregnancy—Amifostine has not been studied in pregnant women. However, in animal studies, large doses caused toxic or harmful effects in the fetus.

Because amifostine may cause birth defects or other harmful effects in the fetus, it is usually recommended that women being treated for cancer use birth control.

Breast-feeding—It is not known whether amifostine passes into the breast milk. Breast-feeding is not recommended during treatment.

Children—Although this medicine has been given to a limited number of children, there is no specific information comparing use of amifostine in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although amifostine has been given to a limited number of elderly people, there is no specific information comparing use of amifostine in the elderly with use in other age groups.

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. When you are receiving amifostine, it is especially important that your health care professional know if you are taking any of the following:

• Amantadine (e.g., Symmetrel) or
• Antidepressants (medicine for depression) or
• Antihypertensives (medicine for high blood pressure) or
• Antipsychotics (medicine for mental illness) or
• Beta-adrenergic blocking agents used in the eye, such as betaxolol (e.g., Betoptic), carteolol (e.g., Ocupress), levobunolol (e.g., Betagan), metipranolol (e.g., OptiPranolol), and timolol (e.g., Timoptic), or
• Bromocriptine (e.g., Parlodel) or
• Deferoxamine (e.g., Desferal) or
• Diuretics (water pills) or
• Levodopa (e.g., Dopar) or
• Medicine for heart disease or
• Nabilone (e.g., Cesamet) (with high doses) or
• Narcotic pain medicine or
• Nimodipine (e.g., Nimotop) or
• Pentamidine (e.g., Pentam) or
• Pimozide (e.g., Orap) or
• Promethazine (e.g., Phenergan) or
• Trimeprazine (e.g., Temaril)—Amifostine sometimes causes low blood pressure while it is being injected. These other medicines may add to this effect and increase the chance of a severe lowering of your blood pressure during treatment. You may have to stop taking the other medicine for a while before amifostine is given, but do not stop taking it on your own. Instead, the doctor who is treating your cancer should plan the best way to avoid this problem together with the doctor who ordered the other medicine for you.

• Dehydration or
• Heart or blood vessel disease or
• Low blood pressure or
• Nausea, history of, or
• Vomiting, history of, or
• Stroke (history of) or
• Transient ischemic attacks (sometimes called TIAs or “ministrokes”), history of—Some of amifostine's side effects can cause harm to patients with these conditions

• Kidney disease—The chance of low blood calcium may be increased in people with some forms of kidney disease

Dosing—

The dose of amifostine will be different for different patients. It depends on the patient's size. The medicine will be given by, or under the immediate supervision of, the doctor treating you for cancer.

• For parenteral dosage form (injection):
  • For preventing or lessening side effects caused by medicines used to treat cancer:
    • Adults—910 milligrams (mg) for each square meter of body surface area, injected into a vein starting 30 minutes before the cancer medicine.
    • Children—Use and dose will have to be determined by the doctor.
  • For preventing or lessening side effects caused by radiation therapy used to treat cancer:
    • Adults—200 milligrams (mg) for each square meter of body surface area, injected into a vein starting 15 to 30 minutes before the radiation treatment.
    • Children—Use and dose will have to be determined by the doctor.

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.

Tell the doctor or the person giving you the injection right away if you feel dizzy or faint while the injection is being given. Also, check with your doctor as soon as possible if any of the following side effects occur later on:

• More common
  • Blurred vision;  confusion;  dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly;  fainting or loss of consciousness;  fast or irregular breathing ;  itching;  nausea and vomiting ;  red, scaly, swollen, or peeling areas of skin;  swelling of eyes or eyelids;  trouble in breathing;  tightness in chest;  wheezing;  skin rash;  sweating ;  unusual tiredness or weakness 
  
  

• Rare
  • Burning or tingling sensation;  convulsions ;  fast, slow or irregular heartbeat or pulse;  loss of bladder control;  muscle cramps ;  muscle spasm or jerking of all extremities;  palpitations 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common or rare
  • fever;  headache;  nervousness;  pounding in the ears;  sleepiness (severe) 
  
  

Other side effects that sometimes occur are harmless and will go away without treatment. These are:

• Less common or rare
  • Feeling unusually warm or cold;  flushing or redness of face or neck;  hiccups 
  
  

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

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in the product labeling, amifostine is used in certain patients with the following medical conditions:

• Mucositis in patients receiving radiation therapy or radiation combined with chemotherapy
• Myelodysplastic syndromes

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.