Frequently Asked Questions About Fludara® (Fludarabine)
Generic Name: Fludarabine (floo-DARE-uh-been)
Trade Name: Fludara®
For which conditions is Fludara approved for? Fludara is FDA approved for the treatment of chronic lymphocytic leukemia that has stopped responding to, or never responded to previous therapies, and may be used as therapy for patients with non-Hodgkin’s lymphoma or acute leukemia that has stopped responding to standard therapies. 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? Fludara belongs to a group of agents called antimetabolites. Fludara produces its anti-cancer effects through chemical reactions that inhibit the production of DNA, RNA and certain proteins. Inhibiting the synthesis of DNA and RNA stops cellular replication and causes cellular death.
How is Fludara typically given (administered)? Fludara may be given intravenously (into a vein)., 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 Fludara. 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 are susceptible to developing a condition called tumor lysis syndrome, in which electrolyte and metabolic disturbances occur. Tumor lysis syndrome can be prevented if treated at an early stage. Blood tests will measures levels of electrolyte and metabolic products, and patients should contact their healthcare provider if they experience symptoms such as nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort.
Patients may also develop a condition called hemolytic anemia when being treated with Fludara. This condition results in very low levels of functioning red blood cells, and although it is uncommon, patients will be monitored for this condition.
An additional uncommon side effect from treatment with Fludara is central nervous toxicity, resulting in weakness, agitation, confusion, visual disturbances, seizures, and/or coma. Although patients will be monitored for this, they should notify their physician if they are experiencing any of these symptoms.
What are the common (occur in 30% or more of patients) side effects of treatment with Fludara?
• Low levels of white blood cells – increases risk of infection
• Low levels of red blood cells – increases risk of anemia and blood transfusions
• Low levels of platelets – increases risk of bleeding
• Nausea and vomiting
• Generalized weakness
• Loss of appetite
What are the less common (occur in 10% to 29% of patients) side effects of treatment with Fludara?
• Numbness or tingling of fingers and toes
• Difficulty breathing
• Fluid retention and/or swelling
• Weight gain
• Muscle aches
• Visual disturbances
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?
• 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.
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?
• Shortness of breath, difficulty breathing
• Inability to urinate or decreased urine
• Signs of infection such as redness or swelling, pain on swallowing, coughing up mucous, or painful urination
• Signs of tumor lysis syndrome: nausea and vomiting, shortness of breath, an irregular heartbeat, clouding of urine, lethargy and/or joint discomfort
• Swelling of ankles, feet or face
• Numbness or tingling of toes or fingers
• Fever, chills, cough, sore throat, flu or cold-like symptoms
• Persistent or severe fatigue/weakness
• Unexplained or excessive bleeding (nosebleeds, bruising, black tarry stools, blood in the urine, etc.)
• Weakness, agitation, confusion, changes in vision, seizures
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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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.