Important Administration Instructions

Hydration and Premedication
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. Additional antiemetics may be required based on the chemotherapy drugs administered.

When administering ETHYOL at the 200 mg/m2 dose, it is recommended that antiemetic medication be administered prior to ETHYOL administration. Oral 5HT3 receptor antagonists, alone or in combination with other antiemetics are recommended in the radiotherapy setting.

Supine Position and Blood Pressure Monitoring
Patients should be kept in a supine position during the ETHYOL infusion.

When administering ETHYOL at the 910 mg/m2 dose, monitor blood pressure before, at least every 5 minutes during the infusion, at the end of the infusion, and thereafter as clinically indicated.

When administering ETHYOL at the 200 mg/m2 dose, monitor blood pressure before and at the end of the infusion, and thereafter as clinically indicated.

Recommended Dose for Reduction of Cumulative Renal Toxicity with Chemotherapy

The recommended starting dose of ETHYOL is 910 mg/m2 administered as a 15-minute intravenous infusion, starting 30 minutes prior to chemotherapy. Do not exceed a 15-minute infusion time due to the increased risk of infusion-related reactions. The use of less than 15-minute infusion times for ETHYOL use with chemotherapy have not been established.

Recommended Dose for Reduction of Moderate to Severe Xerostomia from Radiation of the Head and Neck

The recommended dose of ETHYOL is 200 mg/m2 administered as a 3-minute intravenous infusion, starting 15-30 minutes prior to standard fraction radiation therapy (1.8-2.0 Gy).

Dose Modifications for Infusion-Related Reactions

The infusion of ETHYOL should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in Table 1.

If severe infusion-related reactions occur, immediately and permanently discontinue ETHYOL.

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.

When administering ETHYOL at the 910 mg/m2 dose, if the full dose of ETHYOL cannot be administered, the dose of ETHYOL for subsequent chemotherapy cycles should be 740 mg/m2.

Preparation

Reconstitution
During reconstitution of ETHYOL, the use of gloves is recommended, and avoid contact with the skin or mucous membranes. Follow special handling and disposal procedures [see References (15)].

A vial of ETHYOL may contain more drug than is required for the recommended dose or multiple vials may be needed to obtain the recommended dose.

Reconstitute ETHYOL with 9.7 mL of sterile 0.9% Sodium Chloride Injection, USP. The reconstituted solution contains a concentration of 50 mg/mL amifostine, and should be colorless. The reconstituted solution 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).

Dilution
Further dilute to ETHYOL with 0.9% Sodium Chloride Injection, USP to a final concentration of 5 mg/mL to 40 mg/mL before administration. 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).

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

Incompatibilities

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.