June 30, 2010


By Anonymous User

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?

  • Rash
  • Pruritis (itching)
  • Headache
  • Nausea
  • Fatigue
  • Myalgia (muscle pain)
  • Nasopharyngitis
  • Constipation
  • Diarrhea
  • Low blood cell counts

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.
  • If possible, avoid large crowds or people who are sick or not feeling well
  • Wash hands often to reduce the risk of infection.
  • Avoid activities that may cause injury or bruising.

Are there any special precautions patients should be aware of before starting treatment?

  • 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 interact with 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. It is not known if nilotinib passes into breast milk.
  • Patients should inform their physician about all medical conditions, including heart problems, irregular heartbeat, QTc prolongation or family history of the condition, liver problems, history of pancreatitis, low blood levels of potassium or magnesium, a severe problem with lactose, or surgery to remove the stomach.

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.

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.



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.

Tags: Biological Therapy, T

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