Posted on April 28th, 2009 by
Generic Name: Clofarabine (kloe-FARE-eh-been)
Trade Name: Clolar™
For which conditions is this drug approved? Clofarabine is FDA-approved for the treatment of acute lymphoblastic leukemia in pediatric patients (ages 1 to 21 years), that has recurred or stopped responding to at least two prior 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? Clofarabine belongs to a group of drugs called antimetabolites. Clofarabine produces its anti-cancer effects by inhibiting the ability of a cell to produce DNA or repair DNA. By inhibiting the production and repair of DNA, clofarabine suppresses the ability of a cell to replicate or repair itself, ultimately causing cellular death.
How is clofarabine typically given (administered)? Clofarabine may be administered intravenously (into a vein). The dose and schedule for the administration of clofarabine is dependent upon many factors, including the particular treatment regimen being utilized, the patient’s height and weight, overall health, and the patient’s tolerance of therapy.
How are patients typically monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with clofarabine. Typically, blood may be drawn to check levels of blood cells and to monitor functions of some organ systems, such as the kidneys or liver. Physical examinations, scans, or other measures may also be utilized to assess side effects and response to therapy.
In addition, some 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 managed aggressively at the beginning of treatment. Blood tests will measures levels of electrolyte and metabolic products. 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. Capillary leak syndrome or systemic inflammatory response syndrome may also occur. Patients should immediately report signs of this, including difficulty in breathing, rapid breathing, reduced heart rate, and/or dizziness upon standing or sitting from a supine position.
What are the common (occur in 30% or more of patients) side effects of treatment with clofarabine?
What are the less common (occur in 10% to 29% of patients) side effects of treatment with clofarabine?
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. Click here to view the package insert for [hyperlink here].
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