ETHYOL PRESCRIBING INFORMATION | SAFETY INFORMATION







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How does Ethyol work?
Who should not receive Ethyol?
Taking other medications with Ethyol
How much Ethyol will I receive and how often?
How is Ethyol given?
Important safety information

Ethyol is a prescription medication that can help reduce the severity of xerostomia for patients with head and neck cancer who have undergone surgery followed by radiation involving a substantial portion of the salivary glands (these are located below and in front of the ear).

Ethyol may also be given to patients with advanced ovarian cancer who are being treated with a chemotherapy prescription medication called cisplatin. In these cases, Ethyol may reduce the kidney damage that can occur when patients receive repeated doses of cisplatin.

If you are being treated with radiation or cisplatin and have more questions about these side effects or what you may expect during and after treatment, please ask your physician or nurse.

The following information is intended for patients who will receive or who are receiving Ethyol treatments. It is being provided to help them understand why their physician is recommending Ethyol and what to expect during treatment. However, this guide cannot give patients all the details about Ethyol. Patients should always ask their physician for information about any prescription medications they are receiving.

Cisplatin and radiation are examples of treatments that are often used to kill cancer cells, but they may also damage normal cells in your body. Damage to normal cells can cause side effects.¹

How does Ethyol work?

Your physician or nurse will give you Ethyol before you receive your cisplatin or radiation therapy. This will ensure that Ethyol is present in your normal cells before cisplatin or radiation is given to you. When Ethyol is in your normal cells, it can help protect them from the damaging effects of these therapies.

Who should not receive Ethyol?

You should NOT receive Ethyol if:

You are allergic to amifostine

You have low blood pressure

You are dehydrated

Before you start treatment with Ethyol be sure to tell your physician if you have any other health conditions, such as:

Low blood calcium levels

Heart problems

History of stroke or related conditions

Talk to your physician or nurse if you have any questions about whether Ethyol is right for you.

Taking other medications with Ethyol

Tell your physician or nurse about any and all prescription and non-prescription medications you are taking, including:

High blood pressure medication

Medication for low blood calcium levels

If you are taking medications, your physician may change the dose of those products while you are being treated with Ethyol. After your treatments begin, check with your physician or nurse before taking any new medicines, stopping the ones you already take, or changing the dose of any medications.

How much Ethyol will I receive and how often?

The dose of Ethyol that you will receive depends on many factors, including your height and weight, and whether you are receiving cisplatin to treat advanced ovarian cancer, or you are receiving radiation after surgery to treat head and neck cancer. It is up to your physician to determine the dose of Ethyol you will receive.

How is Ethyol given?

Before administering Ethyol, your healthcare provider may ask you to increase your fluid intake and/or take additional medications to help prevent or control some possible side effects.

Each day before you receive Ethyol:

	Drink 8 to 12 cups of water or other non-alcoholic clear fluids.² This will help to ensure that you are well hydrated.
	If you are receiving Ethyol with cisplatin, your physician may have you stop taking any blood pressure medication the day before you receive Ethyol.

Each day of your Ethyol treatment:

	You may receive other medicine to prevent side effects like nausea and vomiting. It is important to take this medication as directed by your physician to minimize side effects that could occur from treatment.
	Your physician or nurse may give you clear fluids to help prevent side effects.
	A nurse may check your blood pressure before, during, and/or after you receive Ethyol.

Important safety information

Nausea and/or vomiting occur frequently after Ethyol is given and may be severe. Before and after you receive Ethyol, your physician or nurse will check to see if you experience any of these effects. If you experience nausea and vomiting with Ethyol, consult your physician who can prescribe medications to cut down on this side effect. Another common side effect you may experience is a temporary drop in blood pressure. Drinking plenty of fluids may help you lower the risk of experiencing a drop in blood pressure and may help minimize nausea and vomiting. Cutaneous eruptions have also been commonly reported during clinical trials and were generally nonserious.

Less common side effects are:

Flushing (feeling warm)

Dizziness

Fever

Chills

Drowsiness

Hiccups

Allergic reactions

Sneezing

Arrythmias (irregular heartbeat)

Tell your physician if you have any side effects while taking Ethyol.

If you have an allergic reaction, rash, hives, wheezing, throat and/or chest tightness, or other serious breathing difficulties, tell your physician or nurse immediately.

Special notes:

	If your blood pressure drops too much, your physician or nurse may change the position of your body or stop giving you Ethyol until it returns to normal. In very rare cases, a drop in blood pressure has led to seizures, difficulty breathing, or kidney failure.
	Be sure to tell all physicians, dentists, and pharmacists who are treating you that you are receiving Ethyol.

References: 1. American Cancer Society. What causes side effects? Available at: http://www.cancer.org/docroot/ETO/content/ETO_1_7X_What_ Causes_Side_Effects
.asp. Accessed June 14, 2005. 2. National Cancer Institute. Nutrition in cancer care. Available at: http://www.cancer.gov/cancertopics/pdq/supportivecare/nutrition/
patient/allpages. Accessed March 7, 2005.