Amifostine

What is Amifostine?

• Amifostine (Ethyol) is a cytoprotective agent used for Renal (kidney) toxicity, Xerostomia.

WR-1065 skeletal

What are the uses of this medicine?

Amifostine (Ethyol) is used to prevent: Renal (kidney) toxicity:

• It is used to reduce the nephrotoxic effects caused by repeated treatment with cisplatin for advanced ovarian cancer.

Xerostomia (dry mouth):

• It is used to decrease dryness in the mouth caused by radiation therapy after surgery in some patients with head and neck cancer.

Limitation of Use:

• Avoid the use of ETHYOL in settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy.

How does this medicine work?

• 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.
• After dephosphorylation of amifostine by alkaline phosphatase to an active free sulfhydryl (thiol) metabolite, the thiol metabolite binds to and detoxifies cytotoxic platinum-containing metabolites of cisplatin and scavenges free radicals induced by cisplatin and ionizing radiation.
• The elevated activity of this agent in normal tissues results from both the relative abundance of alkaline phosphatase in normal tissues and the greater vascularity of normal tissues compared to tumor tissues.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• known hypersensitivity to aminothiol compounds.

What drug interactions can this medicine cause?

• Closely monitor patients receiving anti-hypertensive medications or other drugs that could cause or potentiate hypotension when used with ETHYOL.

Is this medicine FDA approved?

• Initial U.S. Approval: 1995

How should this medicine be used?

• Prior to ETHYOL infusion, verify that patients are adequately hydrated and correct existing dehydration if clinically indicated.
• When administering ETHYOL at the 910 mg/m2 dose, antiemetic medications, including intravenous dexamethasone 20 mg and a serotonin 5HT3 receptor antagonist, are recommended prior to ETHYOL administration.
• When administering ETHYOL at the 200 mg/m2 dose, it is recommended that antiemetic medication be administered prior to ETHYOL administration.
• Patients should be kept in a supine position during the ETHYOL infusion.

Recommended dosage and administration: Renal (kidney) toxicity:

• For reduction of cumulative renal toxicity with chemotherapy, the recommended starting dose is 910 mg/m2 administered once daily as a 15-minute intravenous infusion, starting 30 minutes prior to chemotherapy.

Xerostomia (dry mouth):

• For reduction of moderate to severe xerostomia from radiation of the head and neck, the recommended dose is 200 mg/m2 administered once daily as a 3-minute intravenous infusion, starting 15-30 minutes prior to standard fraction radiation therapy.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: sterile lyophilized powder in 10 mL single-dose vials.

This medicine is available in fallowing brand namesː

• ETHYOL

What side effects can this medication cause?

The most common side effects of this medicine include:

• hypotension
• nausea
• vomiting

What special precautions should I follow?

• ETHYOL may interfere with the antitumor activity of chemotherapy regimens. Do not use ETHYOL 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).
• ETHYOL may interfere with the antitumor activity of the radiotherapy regimens. Do not use ETHYOL in patients receiving definitive radiotherapy.
• Severe hypotension with serious sequelae have been reported. Patients who are hypotensive or dehydrated should not receive ETHYOL. If interruption of antihypertensive therapy is possible, interrupt antihypertensive therapy 24 hours prior to ETHYOL administration. Monitor blood pressure during infusion; interrupt and restart infusion if decrease in systolic blood pressure is observed. Do not administer ETHYOL to hypotensive patients who are taking antihypertensive therapy that cannot be stopped for 24 hours prior to ETHYOL administration.
• Fatal and severe cutaneous reactions have been reported in clinical studies and post-marketing experience in patients treated with ETHYOL. Monitor patients prior to, during, and weeks after administration for severe cutaneous reactions. Discontinue for cutaneous reactions or lesions appearing outside of the injection site/radiation port or on the palms or soles.
• Hypersensitivity reactions, including anaphylaxis, have been reported. Discontinue for severe acute allergic reactions. Administer treatment for serious allergic events.
• Nausea and/or vomiting occur frequently after ETHYOL infusion and may be severe. Administer antiemetic medication prior to and in conjunction with ETHYOL. Monitor fluid balance when administered with highly emetogenic chemotherapy.
• Monitor serum calcium levels in patients at risk of hypocalcemia, such as those with nephrotic syndrome, or patients receiving multiple doses of ETHYOL. If necessary, calcium supplements can be administered.
• Based on findings in animals, ETHYOL can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus. Also, refer to the cisplatin full prescribing information for pregnancy and contraception information.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• anxiety
• reversible urinary retention
• hypotension

Management of overdosage:

• Hypotension, should be managed by infusion of normal saline and other supportive measures, as clinically indicated.

Can this medicine be used in pregnancy?

• Based on findings in animals, ETHYOL can cause fetal harm when administered to a pregnant woman.
• There are no available data on ETHYOL 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.

Can this medicine be used in children?

• The safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• AMIFOSTINE

Inactive ingredients:

• none

Who manufactures and distributes this medicine?

Manufactured for:

• Clinigen, Inc.
• Yardley, PA

What should I know about storage and disposal of this medication?

• Store the lyophilized dosage form at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
• Follow special handling and disposal procedures.

• Dailymed label info on Amifostine
• FDA Amifostine

Amifostine Resources
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