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Treatment Name: Crizotinib (Xalkori®)

Crizotinib (Xalkori®) is a Chemotherapy Regimen for Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)

How does crizotinib work?
Crizotinib is designed to bind to and block the function of a mutated protein called “anaplastic lymphoma kinase” (ALK) present in cancer cells. The mutated ALK protein causes the cancer cell to grow and divide more rapidly and to survive longer. Approximately 2% to 7% of patients with NSCLC have this mutation. By blocking the function of the abnormally active ALK protein, crizotinib slows the growth of the cancer and causes some of the cancer cells to die.

Goals of therapy:
Crizotinib is given to patients to slow the progression and to stop the spreading of the disease. Crizotinib is not currently given with the goal of cure.

Schedule

  • Usual starting dose: 250 mg oral capsule by mouth twice daily

Crizotinib is usually taken at home. Crizotinib is taken continuously as long as the drug is working and no unacceptable side effects are experienced.

Side Effects

In clinical studies, the most commonly reported side effects with crizotinib are shown here. Side effects sometimes have percentage ranges [example: 48 – 61% get diarrhea] because they differed between in clinical studies:

  • Nausea (56%)
  • Diarrhea (48 - 61%)
  • Vomiting (47%)
  • Visual changes (41 - 71%)
  • Sinus infection (26 - 32%)
  • Altered taste (26%)
  • Abdominal pain (26%)
  • Constipation (24 - 43%)
  • Cough (23%)
  • Headache (22%)
  • Low white blood cells [neutropenia] (21%)
  • Nerve pain (20%)
  • Fever (19%)
  • Fluid accumulation in extremities (16 - 49%)
  • Arm or leg pain (16%)
  • Dizziness (15 - 22%)
  • Mouth sores (14%)
  • Decreased appetite (13 - 30%)
  • Shortness of breath (13 - 18%)
  • Weakness (13%)
  • Liver injury (12 - 38%)
  • Fatigue (10 - 29%)
  • Anemia [low red blood cells] (8%)
  • Rash (9%)
  • Hair loss (8%)
  • Lung injury (1%)

Roughly, 6% - 12% of patients discontinue crizotinib due to unacceptable side effects.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaPainPainConstipationConstipationFatigue Fatigue Hair LossHair LossNeutropenic FeverNeutropenic FeverAnemiaAnemia

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, then every two weeks for the first two months, then monthly while on treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood magnesium levels, plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before treatment and approximately every 6 to 8 weeks during treatment. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans. Electrocardiograms (ECG also known as "EKG") may be performed periodically during treatment to assess your heart rhythm.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue crizotinib as planned, or delay or switch therapy.

ChemoExperts Tips

  • Crizotinib may cause significant nausea and vomiting. An anti-nausea medication is recommended 30 - 60 minutes before each dose of crizotinib to avoid nausea and vomiting due to crizotinib
  • Crizotinib as well as several other medications may increase your risk of experiencing a rare, but serious heart rhythm problem known as "prolonged QTc interval." Talk to your doctor or pharmacist to see if any of your other medications can increase your risk of an abnormal heart rhythm.
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for lung cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Crizotinib (Xalkori®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Crizotinib (Xalkori®). Depending upon your income, they may be able to help cover the cost of:

  • Crizotinib

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Crizotinib (Xalkori®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Crizotinib (Xalkori®)

Individual Drug Label Information

Crizotinib (Xalkori®)

  • Crizotinib is an oral capsule available in 200 mg and 250 mg
  • Taken with or without food. Swallow capsules whole and do not open them
  • If you forget to take a dose, take the missed dose only if it has been less than six hours since the dose was due. If it has been more than six hours, do not take the missed dose and wait until the next regularly scheduled dose is due
  • If you vomit up a dose, do not take another dose to make it up. Take the next dose at the next regularly scheduled time
  • Store at room temperature in a cool, dry place
  • Dosage adjustments may be required for decreased kidney function or severe side effects 
  • May interact with certain antifungal and seizure medications. Ask your doctor or pharmacist to review your medications for any possible interactions
  • May interact with grapefruit and grapefruit juice causing increased blood levels of crizotinib. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment unless otherwise instructed by a physician
  • Avoid smoking and therapy with St. Johns Wort, as each will decrease blood levels of crizotinib which could decrease its effectiveness against the cancer
  • Avoid during pregnancy. Contact your doctor immediately if you think you may have become pregnant. Do not breastfeed for at least 45 days after stopping crizotinib
  • Males with female partners who are of child bearing age should use a condom during treatment and at least 90 days after stopping crizotinib
General Crizotinib (Xalkori) Side Effects
  • Decrease in heart rate. Contact your doctor if your heart rate is slower than normal at rest, or you have signs of a slow heart rate such as dizziness, lightheadedness, or fainting
  • May cause severe eye toxicity. Contact your doctor immediately if you experience any changes in vision
  • Can cause a rare but serious heart arrhythmia. Electrocardiograms (ECG, or "EKG") and blood electrolytes (potassium, magnesium, calcium) may be checked periodically
  • May cause severe diarrhea
  • May cause cough, shortness of breath, respiratory infections, and rare but serious lung injuries
  • Severe liver injury
  • May lower white blood cell count
  • May alter taste or decrease your appetite
  • Constipation
  • Headache
  • Nerve pain, or other generalized pain in your arms and/or legs
  • Fluid build-up, most commonly in the legs
  • Mouth sores
  • May cause fatigue or generalized weakness
  • May decrease fertility
  • Click on the crizotinib (Xalkori) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaHair LossHair LossFatigue Fatigue ConstipationConstipationPainPain

See DailyMed package insert.

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References

1. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non–small-cell lung cancer. New Engl J Med. 2010;363:1693-1703.

2. Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368:2385-2394.

3. Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371:2167-2177.

Created: February 17, 2016 Updated: August 30, 2016

What is Lung Cancer, Non-Small Cell Lung Cancer (NSCLC)?

What is Non-Small Cell Lung Cancer?
A disease of the tissue found in the lung.  Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Known causes include smoking and exposure to environmental toxins.  The stage of NSCLC can vary at diagnosis and throughout treatment.  Stages include stage I, II, III, and IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium

Clinical Studies

If you are interested in reading the clinical trials results, please click on references below:

1. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non–small-cell lung cancer. New Engl J Med. 2010;363:1693-1703.

2. Shaw AT, Kim DW, Nakagawa K, et al. Crizotinib versus chemotherapy in advanced ALK-positive lung cancer. N Engl J Med. 2013;368:2385-2394.

3. Solomon BJ, Mok T, Kim DW, et al. First-line crizotinib versus chemotherapy in ALK-positive lung cancer. N Engl J Med. 2014;371:2167-2177.