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n.

An antineoplastic agent, C₄H₃FN₂O₂, used especially in the treatment of cancers of the skin, breast, and digestive system.

Key Terms: Cytotoxic drug, DNA, Infusion therapy.

Definition

Fluorouracil is a medication that kills cancer cells. It is also known as 5-FU or 5-fluourouracil, and as the brand name Adrucil.

Purpose 5-FU may be used in combination with other chemotherapy agents to treat cancers of the breast, stomach, colon, rectum, and pancreas.

Description 5-FU is a cytotoxic drug. This means that it kills cancer cells. 5-FU kills cells by interfering with the activities of DNA and RNA, which are molecules in the cells important in expressing genetic material.

Recommended Dosage

Most frequently, 5-FU is given as an injection into the vein (intravaneous injection or IV). Many different doses and regimens are used depending on the cancer diagnosis, and patients should discuss with their physician the dose based on the individual protocol used. A sample dose is 500 to 1,000 mg per square meter of body surface area given as a 24-hour infusion for four to five days every three weeks. A dose of 425 mg per square meter of body surface area per day for five days given along with the drug leucovorin is also common.

Precautions

Patients with allergic reaction to 5-FU should not be administered this drug. It is also inadvisable for pregnant women. 5-FU should be administered with caution to patients with impaired liver or kidney function, or in patients with a history of heart problems.

Side Effects

The amount of drug given and the duration of which it is given during a single session greatly influences the side effects seen. For example, when given as a 24-hour continuous infusion, the most common side effects are diarrhea and mouth ulcers. If 5-FU is given as a bolus infusion (a high quantity of the drug all at once), the most common side effect is bone marrow suppression; this results in a decrease of the white blood cells responsible for fighting infections, the platelets responsible for blood clotting, and the red blood cells responsible for providing oxygen to the cells of the body.

The severity of the side effects is increased when 5-FU is given with the drug leucovorin. Vomiting, diarrhea, nausea, and loss of appetite (anorexia) may occur regardless of how 5-FU is administered. The diarrhea side effect may be severe in some patients, and it is important for them to alert their doctor immediately so that appropriate medications for the diarrhea can be prescribed.

5-FU may cause rashes, increased sensitivity to sunlight, changes in skin color, changes to the fingernails, and redness and swelling in the palms of the hands and soles of the feet. Patients who have had heart disease before starting therapy with 5-FU may have problems with blood flow to the heart. Rarely, 5-FU may cause an allergic reaction, dry eyes, sleepiness, confusion, headache, changes in walking gait, involuntary rapid movement of the eyes, and difficulty speaking. When 5-FU is applied directly on the skin, there are usually no side effects except for those to the skin itself. These may include burning sensations, pain, and darkening of the skin color.

Some authorities recommend discontinuation of 5-FU therapy as soon as mild side effects are observed as a way of reducing the extent of injury to the digestive tract. Administration may then be restarted at a lower dose after the side effects have stopped.

Interactions

People taking fluorouracil should consult their doctor before taking any other prescription drug, over-thecounter drug, or herbal remedy.

—Bob Kirsch

n

trade names: Efudex, Fluoroplex; drug class: topical antineoplastic; action: inhibits synthesis of DNA and RNA in susceptible cells; uses: keratosis, basal cell carcinoma.

Brand names: Adrucil®, Carac™, Efudex®, Fluoroplex®

Chemical formula:

Drug Forms:
• Fentanyl transmucosal lozenges (Actiq®) (below)
• Epinephrine inhalation solution
• Citalopram oral solution

Español:
• Pastillas transmucosas (Actiq®) de fentanilo
• Solución para inhalación de epinefrina
• Solución oral de citalopram

Fentanyl transmucosal lozenges (Actiq®)

What are fentanyl transmucosal lozenges?

FENTANYL (Actiq®) relieves pain flares or breakthrough pain that your regularly prescribed long-acting pain medicine does not control. Do not use this medicine for pain that will go away in a few days such as pain from surgery, doctor or dentist visits or any other short-lasting pain. When you place Actiq® in your mouth it will dissolve slowly and the medicine is absorbed through the lining of your mouth. Federal law prohibits the transfer of fentanyl to any person other than the patient for whom it was prescribed. Do not share this medicine with anyone else, it is only for you. Generic fentanyl transmucosal lozenges are not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• dental disease
• diabetes mellitus
• head injury
• heart disease
• intestinal disease
• kidney disease
• liver disease
• lung disease or breathing difficulties
• seizures (convulsions)
• an allergic or unusual reaction to fentanyl, meperidine, other medicines, sulfites, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Use Actiq® when you have an acute breakthrough pain episode. Follow the directions on the prescription. Cut open the package using scissors and remove the unit. Do not open the package until you are ready to use it. Place the unit in your mouth between your cheeks and gum and suck on the medicine. Move the unit around in your mouth, especially along your cheeks. Twirl the handle often. Finish the unit completely to get the most relief. If you finish it too quickly, you will swallow more of the medicine and get less pain relief.

Do not bite or chew the unit. If you feel dizzy or sick to your stomach before you have finished the medicine, remove the unit from your mouth. Dispose of the unit right away or put it in the temporary storage bottle to dispose of latter. You may drink water before using the unit but do not drink or eat anything while using the unit.

• To dispose of the Actiq® unit after use:
Once you have finished the unit and the medicine is totally gone, throw the handle away in a place that is out of the reach of children and pets. If medicine remains on the handle after you have finished, place the handle under hot running tap water until the medicine is gone. Then, throw the handle away out of the reach of children and pets. If you did not finish the entire unit and you cannot immediately get rid of the medicine, put the unit in the temporary storage bottle that you have received in the Actiq® Welcome Kit. Push the unit into the opening on the top of the unit it falls completely into the bottle. NEVER leave unused or partly used units where children or pets can get to them. You should empty the storage bottle and run the handles under hot tap water to get rid of the medicine at least once a day.

What if I miss a dose?

This medicine is used on an "as needed" basis. If you do not finish the whole unit each time you have an episode of breakthrough pain or your if pain is not relieved after finishing a whole unit, call your prescriber or health care professional.

What drug(s) may interact with fentanyl?

• amiodarone
• antidepressant drugs called MAOIs
• anti-retroviral protease inhibitors, especially ritonavir
• bosentan
• butorphanol
• delavirdine
• efavirenz
• erythromycin
• fluconazole
• fluvoxamine
• fluoxetine
• imatinib, STI-571
• itraconazole
• herbal products containing St. John's wort
• ketoconazole
• medicines for diarrhea
• medicines for high blood pressure
• medicines for seizures
• mifepristone, RU-486
• nalbuphine
• nefazodone
• nevirapine
• other strong medicines for pain
• pentazocine
• rifabutin
• rifampin
Because fentanyl may cause drowsiness, other medications that also cause drowsiness may increase this effect of fentanyl. Some medicines that cause drowsiness are:
• alcohol and alcohol-containing medicines
• barbiturates, such as phenobarbital
• certain antidepressants or tranquilizers
• muscle relaxants
• certain antihistamines used in cold medicines
Ask your prescriber or health care professional about other medicines that may increase the effect of fentanyl.

Tell your prescriber or health care professional about all other medicines you that are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also, tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking fentanyl?

Tell your prescriber or health care professional if fentanyl is not easing your pain. You should start to feel some relief from the pain while you are using the unit. You may not get full relief for up to 45 minutes after have finished using the product. If you need to use more than 4 units per day, call your prescriber or health care professional. Visit your prescriber or health care professional for regular checks on your progress.

Do not use a second unit without checking with your prescriber or health care professional. While your exact dose is being determined, you may need to use more than one unit to control your pain. Wait at least 15 minutes after finishing a unit completely before using another.

If you develop problems breathing, slow breathing, remove the unit from your mouth. ATTENTION CAREGIVERS: If you see the person using the unit develop breathing problems or if you have a hard time waking the person, remove the unit from their mouth and call for emergency help.

Use exactly as directed by your prescriber or health care professional. If you are taking fentanyl on a regular basis, do not suddenly stop taking it. Your body becomes used to the fentanyl and when you suddenly stop taking it, you may develop a severe reaction. This does NOT mean you are 'addicted' to fentanyl. Addiction is a behavior related to getting and using a drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine such as fentanyl to control your pain.

You may get drowsy or dizzy when you first start taking fentanyl or change doses. Do not drive, use machinery, or do anything that needs mental alertness until you know how fentanyl affects you. Stand or sit up slowly, this reduces the risk of dizzy or fainting spells. These effects may be worse if you are an older patient. The drowsiness should decrease after taking fentanyl for a couple of days. If you have not slept because of your pain, you may sleep more the first few days your pain is controlled to catch-up on missed sleep.

Be careful taking other medicines which may also make you tired. This effect may be worse when taking these medicines with fentanyl. Alcohol can increase possible drowsiness, dizziness, and confusion and may affect your breathing. Avoid alcohol while taking fentanyl.

Fentanyl will cause constipation. Make sure to take a laxative and/or a stool softener while taking fentanyl. Try to have a bowel movement every 2—3 days, at least. If you do not have a bowel movement for 3 days or more call your prescriber or health care professional. They may recommend using an enema or suppository to help you move your bowels.

Your mouth may get dry. Drinking plenty of water, chewing sugarless gum or sucking on hard sugarless candy may help to relieve dry mouth symptoms. In addition, each Actiq® unit contains sugar. Frequent use of sugar-containing products may increase the risk of dental cavities. Have regular dental check-ups.

Diabetic patients should be aware that each Actiq® unit contains 2 g sugar (approximately ½ teaspoon). Depending upon the number of units used, patients may notice changes in their blood sugar and/or insulin requirements. Discuss any changes in your condition with your health care provider. 

If you are going to have surgery, tell your prescriber or health care professional that you are taking fentanyl.

Rarely, fentanyl may cause you to have hallucinations (to see things that are not really there) or cause your legs or arms to 'jerk' or have spasms. If you experience these effects, call your prescriber or health care professional.

What side effects may I notice from receiving fentanyl?

Side effects that you should report to your prescriber or health care professional as soon as possible:
Rare or uncommon:
• breathing difficulties, wheezing
• cold, clammy skin
• seizures
• slow or fast heartbeat
• severe rash
• unusual weakness
More common:
• confusion
• lightheadedness or fainting spells
• nervousness or restlessness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• itching
• blurred vision
• clumsiness, unsteadiness
• constipation
• decrease or difficulty passing urine
• dizziness, drowsiness
• dry mouth
• flushing
• headache
• nausea/vomiting
• pinpoint pupils
• sweating

Where can I keep my medicine?

Keep out of the reach of children and pets. You should receive an Actiq® Welcome Kit that includes a child-resistant lock, a portable locking pouch and a child-resistant temporary storage bottle to help you store your medicines out of the reach of children. Keep Actiq® in its foil package until you are ready to use it. Do not use if the foil package has been damaged or opened before you are ready to use it. Dispose of the used units properly.

Store at room temperature below 30 degrees C (86 degrees F). Do not refrigerate or freeze. Do not store above 86 degrees F (30 degrees C).

• When you are no longer using Actiq®:
If you are no longer using Actiq® and have unused units in your home, dispose of them as soon as possible. Remove the unit from the pouch using scissors and hold the unit by the handle over the toilet. Using wire-cutting pliers, cut the medicine end off so that it falls into the toilet. Throw the handle away in a place that is out of reach of children. Flush the toilet twice after 5 units have been cut. Do not flush more than 5 units at one time. Do not flush the entire unused units, handles or foil pouches down the toilet.

Last updated: 7/1/2002

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

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