Class: Biological Therapy
Generic Name: Nilotinib
Trade Name: Tasigna®
How is this drug used? Nilotinib is FDA approved for the treatment of newly diagnosed adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, as well as for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib. 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? A genetic abnormality, referred to as the Philadelphia-chromosome, leads to continually active growth signaling to cancer cells in the majority of cases of chronic myeloid leukemia. Nilotinib inhibits the growth signaling processes, suppressing replication of Philadelphia-chromosome positive chronic myeloid leukemia cells.
How is nilotinib given (administered)? Nilotinib is administered orally in the form of a capsule. The dose depends on whether the patient is newly diagnosed with CML or has been previously treated, and also depends on the health of the patient. Nilotinib should not be taken with food.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with nilotinib. Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Electrocardiograms (ECG) are recommended at baseline and periodically thereafter in order to monitor heart function; nilotinib can cause a serious heart problem known as QTc prolongation. Patients may also undergo physical examinations, scans or other measures to assess side effects and response to therapy.
What are the most common (occur in 10% or more of patients) side effects of treatment with nilotinib?
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?
Tell your doctor if you experience any side effect that bothers you or does not go away. Call your doctor immediately if you feel lightheaded, faint, or have an irregular heartbeat; these may be signs of QTc prolongation (a serious heart problem).
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.
Copyright © 2010 CancerConnect Last updated 06/10.
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