Xalkori™

Posted on September 6th, 2011 by

Class: Biological Therapy

Generic Name: Crizotinib

Trade Name: Xalkori®

How is this drug used? Xalkori is used for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors test positive for an abnormality in the anaplastic lymphoma kinase (ALK) gene, or whose tumors are  ROS1-positive.

What is the mechanism of action? Between one percent and seven percent of non-small cell lung cancers have an abnormal version of the ALK gene that contributes to the growth and development of cancer cells. Xalkori blocks certain proteins, including the protein produced by the abnormal ALK gene.

How is Xalkori given (administered)? Xalkori is taken orally (by mouth).

How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Xalkori.  Typically, blood will be drawn to check levels of blood cells and to monitor functions of some organ systems. Patients may undergo physical examinations and other tests to assess side effects and response to therapy.

What are the most common side effects of treatment with Xalkori?

  • Vision problems
  • Nausea
  • Diarrhea
  • Vomiting
  • Swelling of the hands or feet
  • Constipation

What are some of the less common but potentially serious side effects of Xalkori?

  • Swelling of the lungs (pneumonitis)
  • Liver problems
  • Heart problems (QT interval prolongation)

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 discuss side effects with your physician.
  • Do not drink grapefruit juice or eat grapefruit during treatment with Xalkori (it can increase the amount of Xalkori in your body to a harmful level).

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

  • Patients should inform their physician about all medical conditions, including problems with the heart, liver, or kidneys.
  • Patients should inform their physician of any other medication or supplement they are taking (whether prescription or over-the-counter), including St. John’s Wort, antidepressants, anti-fungal medications, antibiotics, and medicines for tuberculosis, HIV-AIDS, heart conditions, and seizures.
  • Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. Xalkori may harm an unborn baby.
  • If patients experience vision changes, dizziness, or fatigue while taking Xalkori, they should use caution when driving a car or using machinery.

When should patients notify their physician?

Tell your doctor if you experience any side effects that bother you or don’t go away. Tell your doctor right away if you have any changes to your vision, such as flashes of light, blurred vision, sensitivity to light, or new or increased floaters. Also watch for signs of serious side effects and report these to your doctor immediately: symptoms of lung swelling include new or worsening problems with breathing or shortness of breath, cough, or fever; symptoms of liver problems include a yellowing of the skin or the whites of the eyes, feeling tired, dark or brown urine, nausea or vomiting, decreased appetite, pain on the right side of the stomach, and easy bruising or bleeding; and symptoms of QT interval prolongation (a heart problem) include abnormal heartbeats and feeling dizzy or faint.

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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Tags: Biological Therapy, X

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