Generic Name: fluorouracil (fler-oh-YOO-rah-sil), 5-FU, 5-fluorouracil
Trade Name: Adrucil®, Carac®, Efudex® and Fluoroplex®
For which conditions is Efudex approved for? Efudex is FDA approved for the treatment of the following conditions: anal cancer, cervical cancer, colon cancer, rectal cancer, breast cancer, stomach (gastric) cancer, head and neck cancer, bladder cancer, neuroendocrine tumors, hepatobiliary cancers, thymic cancers, and pancreatic cancer. Efudex may also come in a topical form that is FDA approved for the treatment of superficial basal cell carcinoma. It is important for patients to remember that physicians have the ability to prescribe medication for conditions other than those for which the drug has been approved by the FDA. Patients who have received a prescription of this drug for a condition other than which it is approved may wish to discuss this issue with their physician.
What is the mechanism of action? Efudex belongs to a class of agents called antimetabolites. Antimetabolites produce their anti-cancer effects by inhibiting the ability of a cell to produce or repair DNA, thereby making the cell unable to replicate or repair itself and ultimately causing cellular death.
How is Efudex typically given (administered)? Efudex may be given intravenously (into a vein), and may be applied topically as a skin cream. The information on this sheet mainly covers the intravenous formulation. The dose depends on several factors, including the condition being treated, the size of the patient, the particular regimen being used, and the overall health of the patient.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with flourouracil. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy. In addition, patients will have their heart function monitored, as treatment with Efudex may produce damage to the heart. Patients should notify their healthcare provider if they notice changes in heart rate or rhythm, or experience chest pain. Patients who are using the topical Efudex will also undergo skin assessments.
What are the common (occur in 30% or more of patients) side effects of treatment with Efudex?
- Low levels of white blood cells – increases the risk of infection
- Low levels of red blood cells – increases the risk of anemia and blood transfusions
- Low levels of platelets – increases the risk of bleeding
- Mouth sores
- Loss of appetite
- Changes in taste, metallic taste in mouth following IV bolus injection
- Reactions of the eyes resulting in watery eyes or sensitivity to sunlight
- Discoloration of vein in which the drug was administered
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Efudex?
- Pain, peeling, redness, rash, or swelling of the palms of the hands or soles of the feet (hand-foot syndrome)
- Discoloration of the skin
- Darkening of the skin where previous radiation was administered?
- Rash or itching
- Skin sensitivity to sunlight
- Hair loss
- Discoloration of nails, loss of nails
- Cracking, peeling or excessively dry skin
What are possible late side effects of treatment with Efudex? With the use of this drug, there is risk of developing damage to the heart after treatment is completed, although this is uncommon. Patients experiencing chest or jaw pain, difficulty breathing, sweating or noticeable changes in heart rate or rhythm should contact their healthcare provider immediately.
This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.
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Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.
What can patients do to help alleviate or prevent discomfort and side effects?
- Pay careful attention to the physician’s instructions and inform the physician of any side effects.
- Maintain adequate rest and nutrition.
- Wear sunscreen and protective clothing and try to minimize sun exposure.
- Drink plenty of fluids. (Patients should ask their physician about the amount of liquid to consume during a day.)
- If possible, avoid large crowds or people who are sick or not feeling well, as this drug may leave some patients susceptible to infection.
- Wash hands often to reduce the risk of infection.
- Eat small meals frequently to help alleviate nausea.
- If patients have been prescribed an anti-nausea medication, they should be sure to take the prescribed doses.
- Avoid activities that may cause injury or bruising.
- Use a soft toothbrush and an electric razor to prevent cuts on the mouth or skin.
- For mouth sores, patients should rinse their mouth three times a day with a salt and soda solution (8 ounces of water mixed with ½ to 1 tsp baking soda and/or ½ to 1 tsp salt) and brush their teeth with a soft toothbrush to help prevent the development of mouth sores.
Are there any special precautions patients should be aware of before starting treatment?
- Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. This drug may cause birth defects. It is important to use some kind of birth control while undergoing treatment. Also, patients may want to talk to their physician if they are considering having children in the future, since some drugs may cause fertility problems.
- It is important that patients inform their physician of any pre-existing conditions (chicken pox, heart disease, kidney disease, liver disease, lung disease, etc.) as they may worsen with this drug.
- Patients should inform their physician of any other medication they are taking (whether prescription or over-the-counter, including vitamins, herbs, etc.) as they may interfere with treatment.
- Patients should check with their physician before starting any new drug or nutritional supplement.
- Patients should inform their physician of any known drug or food allergies or any reactions to medications they have experienced in the past.
When should patients notify their physician?
- Chest pain or palpitations
- Noticeable changes in heart rate or rhythm
- Excessive pain or peeling of the palms of the hands or soles of the feet
- Excessive peeling or cracking of skin
- Flu or cold-like symptoms: fever, chills, sore throat, cough
- Signs of infection – redness, swelling, pus, tenderness, painful urination
- Persistent or severe fatigue
- Unexplained or pronounced bleeding (nosebleeds, bruising, blood in the urine, black tarry stools, etc.)
- Mouth sores
- Persistant nausea, vomiting or abdominal pain
- Persistant or severe diarrhea
- Vision changes
- Confusion, mental changes
- Allergic reaction including swelling of the mouth, lips, and/or throat, wheezing or difficulty breathing, hives or rash
What is a package insert? A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics, and metabolism of the specific drug.By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy, or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition, or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment in selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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