Ethyol

The Burden of Xerostomia

Xerostomia is a significant and debilitating effect of radiotherapy

  • Up to 80% of patients receiving radiotherapy may experience xerostomia4
  • Xerostomia may occur
    • Within a few days following treatment and for a period of several months; yet, be reversible4-6
    • Months or years after treatment, when the condition is progressive, irreversible, and negatively impacts a patient’s quality of life4-7

  • Compositional changes may occur, causing the saliva to become more viscous and appear yellow, brown, or white in color4
  • Patients may experience a sore throat and changes in vocal quality4
  • Dryness of the mouth and lips may make it difficult to eat4
    • Patients may lose their sense of taste or find that food tastes metallic or salty
    • They may find it difficult to chew and swallow
  • Patients may not be able to wear or tolerate dentures4,5
    • Dentures may move and shift, altering one’s appearance and ability to speak and eat, and damaging the vulnerable mucosa further

References:
4. Pinna R, Campus G, Cumbo E, et. al. Xerostomia induced by radiotherapy: an overview of the physiopathology, clinical evidence, and management of the oral damage. Ther Clin Risk Manag. 2015;11:171-188. 5. Tanasiewicz M, Hildebrandt T, Obersztyn I. Xerostomia of various etiologies: a review of the literature. Adv Clin Exp Med. 2016;25(1):199-206. 6. Langendijk JA, Doornaert P, Verdonck-de Leeuw IM, et. al. Impact of late treatment-related toxicity on quality of life among patients with head and neck cancer treated with radiotherapy. J Clin Oncol. 2008;26(22):3770-3776. 7. Berkey FJ. Managing the adverse effects of radiation therapy. Am Fam Physician. 2010;82(4):381-388.

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.

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.

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 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.

Click here to view Full Prescribing Information.