For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens or radiation therapy is altered by ETHYOL.

There are at present only limited data on the effects of ETHYOL on the efficacy of chemotherapy or radiotherapy in other settings. ETHYOL should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study (see WARNINGS).

For Reduction of Cumulative Renal Toxicity with Chemotherapy: The recommended starting dose of ETHYOL is 910 mg/m² administered once daily as a 15-minute i.v. infusion, starting 30 minutes prior to chemotherapy.

The 15-minute infusion is better tolerated than more extended infusions. Further reductions in infusion times for chemotherapy regimens have not been systematically investigated.

Patients should be adequately hydrated prior to ETHYOL infusion and kept in a supine position during the infusion. Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.

The infusion of ETHYOL should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below:

If the blood pressure returns to normal within 5 minutes and the patient is asymptomatic, the infusion may be restarted so that the full dose of ETHYOL may be administered. If the full dose of ETHYOL cannot be administered, the dose of ETHYOL for subsequent chemotherapy cycles should be 740 mg/m².

It is recommended that antiemetic medication, including dexamethasone 20 mg i.v. and a serotonin 5HT₃ receptor antagonist, be administered prior to and in conjunction with ETHYOL. Additional antiemetics may be required based on the chemotherapy drugs administered.

For Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck: The recommended dose of ETHYOL is 200 mg/m² administered once daily as a 3-minute i.v. infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy).

Patients should be adequately hydrated prior to ETHYOL infusion. Blood pressure should be monitored at least before and immediately after the infusion, and thereafter as clinically indicated.

It is recommended that antiemetic medication be administered prior to and in conjunction with ETHYOL. Oral 5HT₃ receptor antagonists, alone or in combination with other antiemetics, have been used effectively in the radiotherapy setting.

ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of amifostine on the anhydrous basis.

Prior to intravenous injection, ETHYOL is reconstituted with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution (500 mg amifostine/10 mL) is chemically stable for up to 5 hours at room temperature (approximately 25°C) or up to 24 hours under refrigeration (2°C to 8°C).

ETHYOL prepared in polyvinylchloride (PVC) bags at concentrations ranging from 5 mg/mL to 40 mg/mL is chemically stable for up to 5 hours when stored at room temperature (approximately 25°C) or up to 24 hours when stored under refrigeration (2°C to 8°C).

CAUTION: Parenteral products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if cloudiness or precipitate is observed.

The compatibility of ETHYOL with solutions other than 0.9% Sodium Chloride for Injection, or Sodium Chloride solutions with other additives, has not been examined. The use of other solutions is not recommended.

ETHYOL (amifostine) for Injection is supplied as a sterile lyophilized powder in 10 mL single-use vials (NDC 58178-017-01). Each single-use vial contains 500 mg of amifostine on the anhydrous basis. The vials are available packaged as follows:

3 pack - 3 vials per carton (NDC 58178-017-03)

Store the lyophilized dosage form at Controlled Room Temperature 20°-25°C (68°-77°F) [See USP].

U.S. Patents 5,424,471; 5,591,731; 5,994,409

Manufactured by: MedImmune Pharma B.V., 6545 CG Nijmegen , The Netherlands Or: Ben Venue, Inc.

Bedford, Ohio 44146 Marketed by: MedImmune Oncology, Inc. a subsidiary of MedImmune, Inc., Gaithersburg, MD 20878 For product information, please call 1 877 633 4411 © 2003 MedImmune Oncology, Inc.Revision Date 3/2003

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