Ethyol

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
CONTRAINDICATIONS

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.

Serious cutaneous reactions such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxoderma and exfoliative dermatitis have been associated with ETHYOL administration. The reported incidence of serious skin reactions is higher in patients receiving ETHYOL as a radioprotectant than in patients receiving ETHYOL as a chemoprotectant. In case of severe allergic reactions including anaphylaxis and severe cutaneous 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. The fluid balance of the patient should be carefully monitored when ETHYOL is administered with highly emetogenic chemotherapy. Serious cutaneous reactions may develop weeks after initiation of ETHYOL administration.

ADVERSE REACTIONS
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 flushing, chills, malaise, fever, diplopia, blurred vision, rash, dizziness, somnolence, hiccups and sneezing. Injection site reactions including pruritus and urticaria were also observed.

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