Posted on April 28th, 2009 by
Generic Name: fluorouracil (fler-oh-YOO-rah-sil), 5-FU, 5-fluorouracil
Trade Name: Adrucil®, Carac®, Efudex® and Fluoroplex®
For which conditions is this drug approved? Fluorouracil 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. Fluorouracil 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? Fluorouracil 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 fluorouracil typically given (administered)? Fluorouracil 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 fluorouracil 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 fluorouracil will also undergo skin assessments.
What are the common (occur in 30% or more of patients) side effects of treatment with fluorouracil?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with fluorouracil?
What are possible late side effects of treatment with fluorouracil? 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.
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?
Are there any special precautions patients should be aware of before starting treatment?
When should patients notify their physician?
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.
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