Amifostine

Amifostine is a prescription medication used for the treatment of renal toxicity caused by treatment with a certain anti-cancer drug (cisplatin). Amifostine is also used to prevent dry mouth caused by radiation treatment for head and neck cancer.

• Amifostine is available under the following different brand names: Ethyol

Common side effects of Amifostine include:

• nausea and vomiting (can be frequent and severe)
• flushing (warmth, redness, or tingly feeling)
• chills
• unusual feelings of warmth or cold
• dizziness
• drowsiness
• hiccups
• sneezing
• fever, or
• general ill feeling

Serious side effects of Amifostine include:

• severe or ongoing vomiting;
• a light-headed feeling;
• weak or shallow breathing;
• chest pain, fast or slow heart rate;
• a seizure; or
• redness, rash, or blisters on the palms of the hands or the soles of the feet.

Rare side effects of Amifostine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Powder for injection

• 500 mg/vial

Nephrotoxicity

Adult dosage

• 910 mg/m² IV (15-minute infusion), 30 minutes before chemotherapy 

Xerostomia

Adult dosage

• 200 mg/m² IV (3-minute infusion), 15-30 minutes before radiation therapy  
• 500 mg SC every day prior to radiation therapy

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Amifostine has severe interactions with no other drugs.
• Amifostine has serious interactions with no other drugs.
• Amifostine has moderate interactions with at least 112 other drugs.
• Amifostine has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to aminothiol, monitor closely during and after IV

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Amifostine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Amifostine?”

Cautions

• Cardiovascular disease, hypocalcemia, hypotension, cutaneous reactions, or nausea/vomiting may occur
• Administer antiemetic medication prior to and in conjunction with therapy; monitor fluid balance when administered with highly emetogenic chemotherapy
• Monitor serum calcium levels in patients at risk of hypocalcemia; if necessary, administer calcium supplements
• Ensure adequate hydration
• Antitumor interference
• Drug may interfere with the antitumor activity of chemotherapy regimens
• Do not use in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure (e.g., certain malignancies of germ cell origin); except in the context of a clinical study
• Limited data are currently available regarding interference with antitumor efficacy when the drug is administered prior to cisplatin therapy in settings other than advanced ovarian cancer
• Radiotherapy interference
  • Drug may interfere with the antitumor activity of radiotherapy regimens; do not use in patients receiving definitive radiotherapy, except in the context of a clinical trial; there are insufficient data to exclude a tumor-protective effect in this setting
  • Safety and efficacy of Ethyol on the incidence of xerostomia in the setting of combined chemotherapy and radiotherapy, and in the setting of accelerated or hyperfractionated therapy, have not been established
• Cardiovascular events
  • Patients who are hypotensive or dehydrated should not receive therapy
  • If interruption of antihypertensive therapy is possible, interrupt antihypertensive therapy 24 hours prior to therapy administration
  • Hypotensive patients unable to safely interrupt antihypertensive therapy should not receive therapy
  • Monitor blood pressure during infusion; interrupt and restart infusion if a decrease in systolic blood pressure observed
• Severe cutaneous reactions
  • Fatal and serious cutaneous reactions reported with therapy, including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS)
  • Reactions have been reported more frequently when the drug is used as a radioprotectant
  • Monitor patients carefully prior to, during and after therapy administration; discontinue therapy for cutaneous reactions or mucosal lesions appearing outside of the injection site or radiation port and for erythematous, edematous or bullous lesions on palms or soles

Pregnancy and Lactation

• When used in combination with cisplatin, refer to cisplatin full prescribing information
• Verify pregnancy status in females of reproductive potential prior to initiating therapy
• Based on findings in animals, therapy can cause fetal harm when administered to a pregnant woman
• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes
• Advise pregnant women and females of reproductive potential of the potential risk to a fetus
• Infertility
  • Based on findings from animal studies, therapy may impair fertility in males of reproductive potential
• Lactation
  • When used in combination with cisplatin, refer to cisplatin full prescribing information for lactation information
  • There are no data on the presence of amifostine or metabolites in human milk, effects on breastfed child, or on milk production
  • Because of the potential for serious adverse reactions in a breastfed child, advise lactating women not to breastfeed during treatment