Ethyol

Effective in Xerostomia

Pretreatment with ETHYOL® (amifostine) significantly reduces early- and later-onset xerostomia in patients with head and neck cancer

*According to Radiation Therapy Oncology Group (RTOG) late radiation morbidity scoring criteria.
†Data from Brizel et al 2000.
‡Data from Wasserman et al 2005.
  • Xerostomia in patients pretreated with ETHYOL did not occur until higher cumulative doses of radiation had been delivered2
  • The most commonly reported side effects were nausea, vomiting, allergic reaction and hypotension2
Brizel study overview: An open-label, phase 3, multi-institutional, randomized trial of 303 patients with newly diagnosed, previously untreated squamous cell head and neck cancer. ETHYOL 200 mg/m2 was administered 15 to 30 minutes before radiotherapy daily as a 3-minute IV infusion. The mean dose of radiation delivered was 64 ± 8 Gy in the ETHYOL + radiation patients and 65 ± 5 Gy in the radiotherapy alone patients. The primary end points included the incidence of grade ≥2 acute and late xerostomia (1 year after the initiation of treatment).2

†Data from Brizel et al 2000.
‡Data from Wasserman et al 2005.
  • More than 70% of patients pretreated with ETHYOL continued to have significantly more meaningful unstimulated saliva production 2 years after radiotherapy (P=0.082 at 24 months)3
  • Significantly more patients pretreated with ETHYOL reported improvements in mouth dryness from 12 to 24 months (P<0.001)3
Wasserman study overview: A 2-year follow-up study to the open-label, phase 3 study conducted by Brizel et al (2000), that evaluated the effects of ETHYOL on chronic xerostomia and tumor control 18 and 24 months after initial radiotherapy. The objectives were to evaluate the magnitude of xerostomia improvement and the potential compromise to the antitumor efficacy of radiotherapy over a longer, more clinically relevant follow-up time. Analysis was performed at 18 and 24 months.3


References:

2. Brizel DM, Wasserman TH, Henke M, et al. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol. 2000;18(19):3339-3345. 3. Wasserman TH, Brizel DM, Henke M, et al. Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and-neck cancer: 2-year follow-up of a prospective, randomized, phase III trial. Int J Radiat Oncol Biol Phys. 2005;63(4):985-990. 8. Hensley ML, Hagerty KL, Kewalramani T, et al. American Society of Clinical Oncology 2008 Clinical Practice Guideline Update: use of chemotherapy and radiation therapy protectants. J Clin Oncol. 2009;27(1):127-145.

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.

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