ave been reported rarely. (See WARNINGS and PRECAUTIONS)
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Overdosage
In clinical trials, the maximum single dose of Amifostine was 1300 mg/m2. No information is available on single doses higher than this in adults. In the setting of a clinical trial, pediatric patients have received single Amifostine doses of up to 2700 mg/m2. At the higher doses, anxiety and reversible urinary retention occurred.
Administration of Amifostine at 2 and 4 hours after the initial dose has not led to increased nausea and vomiting or hypotension. The most likely symptom of overdosage is hypotension, which should be managed by infusion of normal saline and other supportive measures, as clinically indicated.
Amifostine Dosage and Administration
For Reduction of Cumulative Renal Toxicity with Chemotherapy: The recommended starting dose of Amifostine for injection 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 Amifostine for injection 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 Amifostine for injection should be interrupted if the systolic blood pressure decreases significantly from the baseline value as listed in the guideline below:
Guideline for Interrupting Amifostine for injection Infusion Due to Decrease in Systolic Blood Pressure Baseline Systolic Blood Pressure (mm Hg)
<100 100 to 119 120 to 139 140 to 179 ≥180
Decrease in systolic blood pressure during infusion of Amifostine for injection (mm Hg) 20 25 30 40 50
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 Amifostine for injection may be administered. If the full dose of Amifostine for injection cannot be administered, the dose of Amifostine for injection 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 Amifostine for injection. Additional antiemetics may be required based on the chemotherapy drugs administered.
Reconstitution
Amifostine for Injection is supplied as a sterile powder requiring reconstitution for intravenous infusion. Each single-use vial contains 500 mg of Amifostine on the anhydrous basis.
Prior to intravenous injection, Amifostine for injection 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).
Amifostine for injection 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: Parente |
