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.

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
6:59 PM 11/4/2009

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.