idelines for interrupting and restarting Amifostine infusion if a decrease in systolic blood pressure should occur are provided in the DOSAGE AND ADMINISTRATION section. Hypotension may occur during or shortly after Amifostine infusion, despite adequate hydration and positioning of the patient (see ADVERSE REACTIONS and PRECAUTIONS). Hypotension has been reported to be associated with dyspnea, apnea, hypoxia, and in rare cases seizures, unconsciousness, respiratory arrest and renal failure.
3. Cutaneous Reactions
Serious cutaneous reactions have been associated with Amifostine administration. Serious cutaneous reactions have included erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, toxoderma and exfoliative dermatitis. These reactions have been reported more frequently when Amifostine is used as a radioprotectant (see ADVERSE REACTIONS). Some of these reactions have been fatal or have required hospitalization and/or discontinuance of therapy. Patients should be carefully monitored prior to, during and after Amifostine administration. Serious cutaneous reactions may develop weeks after initiation of Amifostine administration (see PRECAUTIONS).
4. Hypersensitivity
Allergic manifestations including anaphylaxis and severe cutaneous reactions have been associated with Amifostine administration.
Nausea and Vomiting
Antiemetic medication should be administered prior to and in conjunction with Amifostine (see DOSAGE AND ADMINISTRATION). When Amifostine is administered with highly emetogenic chemotherapy, the fluid balance of the patient should be carefully monitored.
5. Hypocalcemia
Serum calcium levels should be monitored in patients at risk of hypocalcemia, such as those with nephrotic syndrome or patients receiving multiple doses of Amifostine (see ADVERSE REACTIONS). If necessary, calcium supplements can be administered.
Precautions
General
Patients should be adequately hydrated prior to the Amifostine infusion and blood pressure should be monitored (see DOSAGE AND ADMINISTRATION).
The safety of Amifostine administration has not been established in elderly patients, or in patients with preexisting cardiovascular or cerebrovascular conditions such as ischemic heart disease, arrhythmias, congestive heart failure, or history of stroke or transient ischemic attacks. Amifostine should be used with particular care in these and other patients in whom the common Amifostine adverse effects of nausea/vomiting and hypotension may be more likely to have serious consequences.
Prior to chemotherapy, Amifostine should be administered as a 15-minute infusion (see DOSAGE AND ADMINISTRATION). Blood pressure should be monitored every 5 minutes during the infusion, and thereafter as clinically indicated.
Cutaneous Reactions
Cutaneous reactions may require permanent discontinuation of Amifostine or urgent dermatologic consultation and biopsy (see below).
Cutaneous eva luation of the patient prior to each Amifostine administration should be performed with particular attention paid to the development of the following:
Any rash involving the lips or involving mucosa not known to be due to another etiology (e.g., radiation mucositis, herpes simplex, etc.)
Erythematous, edematous, or bullous lesions on the palms of the hands or soles of the feet and/or other cutaneous reactions on the trunk (front, back, abdomen)
Cutaneous reactions with assoc |
