ETHYOL and Xerostomia

What is ETHYOL?

ETHYOL^® is a prescription drug given by injection prior to each postoperative radiation treatment session for head and neck cancer. ETHYOL is used to lower the rate of moderate to severe xerostomia (dry mouth). It is used in patients receiving radiation therapy following surgery for head and neck cancer when the radiation area includes a large part of the parotid glands (the largest of the salivary glands).

ETHYOL is not approved for use in combination with radiation therapy other than as described above.

Why would my doctor prescribe ETHYOL?

Your doctor probably chose ETHYOL because it helps protect you from moderate to severe xerostomia (pronounced zero-stow-me-uh) that can be caused by radiation treatment of the head and neck regions following surgery. Xerostomia is a loss of saliva production resulting in dry mouth. This happens when your salivary glands are damaged and aren't working properly. This type of damage can occur during radiation treatment and may become apparent during treatment or after treatment is completed. Studies have shown that ETHYOL helps protect salivary gland tissue from damage caused by radiation, specifically to the parotid glands (the largest of the salivary glands).

How does ETHYOL work?

When given before each radiation treatment session, ETHYOL enters parotid gland cells and helps protect the cells against the toxic effects of radiation therapy.

What are the benefits of adding ETHYOL to radiation therapy?

Giving ETHYOL before each radiation treatment can significantly reduce the incidence of moderate to severe xerostomia. A clinical trial studied ETHYOL in patients with head and neck cancer undergoing radiation therapy. Half of these patients received ETHYOL; the other half did not. Salivary function in all of the patients was checked about 9-12 months after they finished radiation therapy, and it was checked again another year later. Fewer patients in the group treated with ETHYOL had moderate to severe xerostomia compared with patients in the group that were not treated with ETHYOL.^1-3

Please see important safety information and full Prescribing Information.

References
1. ETHYOL^® (amifostine) for Injection [package insert]. Gaithersburg, MD: MedImmune, LLC, 2007.
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;18:3339-3345.
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;63:985-990.

Indication

ETHYOL is not approved for use in combination with radiation therapy other than as described above.

Important Safety Information

Allergic reactions, including sudden severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue) and severe skin reactions, have been associated with ETHYOL administration. Some severe reactions have been fatal or have required hospitalization and/or stopping ETHYOL. Severe skin reactions can develop weeks after starting ETHYOL treatment. Minor skin reactions have also been commonly reported. Nausea and/or vomiting occur frequently after ETHYOL is given, and may be severe. Your health care team should monitor you carefully before, during, and after ETHYOL therapy.

In a radiotherapy clinical trial of patients with head and neck cancer, the most common side effects reported in patients receiving ETHYOL were nausea/vomiting (53%) and low blood pressure (15%). Other side effects reported during or after ETHYOL therapy were flushing (feeling warm), chills, malaise (general feeling of sickness), fever, rash, dizziness, drowsiness, hiccups, and sneezing.

You should not take ETHYOL if you:

Have low blood pressure
Are dehydrated
Have an allergy to ETHYOL or any of its ingredients

When receiving ETHYOL:

Take antinausea medications if prescribed by your doctor. Medications should be taken when and as directed
Drink plenty of fluids as directed by your doctor
Have your blood pressure monitored by a member of your health care team
Your doctor may monitor your serum calcium levels
Promptly report any skin reactions to your doctor

Tell your doctor about your health history and any other medications you are taking, as these medications may need to be stopped during ETHYOL therapy.

Please see full Prescribing Information for ETHYOL.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

ETHYOL^® is a registered trademark held by MedImmune, LLC, a member of the AstraZeneca group of companies.

This site is intended for US consumers only.

Scroll down for Important Safety Information