ETHYOL® is supplied in a single-dose vial containing 500 mg of amifostine. For intravenous administration (IV), ETHYOL should be reconstituted with 9.7 ml of sterile 0.9% Sodium Chloride Injection.
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).
It is recommended that antiemetic medication, including dexamethasone 20 mg IV 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 Cumulative Renal Toxicity with Chemotherapy:
The recommended starting dose of ETHYOL is 910 mg/m2 administered once daily as a 15-minute IV infusion, starting 30 minutes prior to chemotherapy. The 15-minute infusion is better tolerated than more extended infusions.
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.
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 IV 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.
Pretreat with ETHYOL® (amifostine) without compromising antitumor efficacy
To reduce potential hypotensive events1:
Indication: ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.
ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.
IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Patients should be adequately hydrated prior to ETHYOL infusion. Blood pressure should be monitored prior to, during and immediately after infusion. Antiemetic medication should be administered prior to and in conjunction with ETHYOL.
IMPORTANT SAFETY INFORMATION
ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.
WARNINGS AND PRECAUTIONS
ETHYOL should not be administered in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure. ETHYOL should not be administered in patients receiving definitive radiotherapy, since there are at present insufficient data to exclude a tumor-protective effect in this setting.
Patients who are hypotensive or in a state of dehydration should not receive ETHYOL. Patients should have antihypertensive therapy interrupted 24 hours preceding administration of ETHYOL. Patients should not receive ETHYOL where therapy cannot be stopped for 24 hours preceding treatment.
The fluid balance of the patient should be carefully monitored when ETHYOL is administered with highly emetogenic chemotherapy.
Fatal and serious cutaneous reactions such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS) have been reported with ETHYOL treatment. These reactions is higher in patients receiving ETHYOL as a radioprotectant. Serious cutaneous reactions may develop weeks after initiation of ETHYOL administration. Discontinue Ethyol for cutaneous reactions or mucosal lesions appearing outside the injection site or radiation port and for erythematous, edematous or bullous lesions on the palms or soles. Monitor patients carefully prior to, during and after ETHYOL administration. In case of severe acute allergic reactions ETHYOL should be immediately and permanently discontinued. Epinephrine and other appropriate measures should be available for treatment of serious allergic events such as anaphylaxis.
In a randomized study of patients with ovarian cancer given ETHYOL, the most common adverse events included transient hypotension, nausea, vomiting, and a decrease in serum calcium concentrations. Other adverse events reported in clinical studies involving patients with ovarian or head and neck cancers include hypersensitivity and anaphylactic reactions, flushing, chills, malaise, pyrexia, diplopia, blurred vision, rash, dizziness, somnolence, hiccups, diarrhea, and sneezing. Injection site reactions including pruritus and urticaria were also observed.
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