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Treatment Name: Ceritinib (Zykadia®)

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

How does ceritinib work?
Ceritinib 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, ceritinib slows the growth of the cancer and causes some of the cancer cells to die.

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

Schedule

  • Usual starting dose: 750 mg (five 150 mg) oral capsules by mouth daily

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

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability

Side Effects

In clinical studies, the most commonly reported side effects with ceritinib are shown here:

  • Nausea (83%)
  • Diarrhea (83%)
  • Vomiting (65%)
  • Fatigue (51%)
  • Liver injury (41%)
  • Constipation (36%)
  • Abdominal pain (38%)
  • Decreased appetite (32%)
  • Cough (23%)
  • Weakness (20%)
  • Weight loss (20%)
  • Fever (20%)
  • Shortness of breath (15%)
  • Headache (15%)
  • Trouble sleeping (15%)
  • Dizziness (14%)
  • Back pain (12%)
  • Joint pain (12%)
  • Muscle pain (11%)
  • Arm or leg pain (11%)
  • Mouth sores (11%)
  • Anemia [low red blood cell count] (11%)
  • High blood sugar (10%)
  • Rash (10%)
  • Fluid accumulation in extremities (9%)
  • Sinus infection (7%)
  • Altered taste (6%)

Roughly 6% of patients discontinue ceritinib due to unacceptable side effects.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment and then periodically during treatment. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), blood magnesium levels, blood phosphorous levels, plus any others your doctor may order. Moderate to severe nausea (occurs in 5% of patients) and moderate to severe diarrhea (occurs in 7% of patients) may lead to dehydration and electrolyte imbalances. Blood tests may be more frequent in cases of severe nausea or diarrhea.

How often is imaging needed?
Imaging may be checked before treatment and up to every six 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 ceritinib as planned, or delay or switch therapy.

ChemoExperts Tips

  • May cause significant nausea and vomiting. An anti-nausea medication is recommended 30 - 60 minutes before each dose to avoid or minimize nausea and vomiting
  • Ceritinib, in addition to some other medications, may increase your risk of experiencing a rare but serious heart rhythm problem known as a prolonged QTc interval. Talk to your doctor or pharmacist to see if any of your other medications can increase your risk of an arhythmia
  • 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 Ceritinib (Zykadia®), 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 Ceritinib (Zykadia®). Depending upon your income, they may be able to help cover the cost of:

  • Ceritinib

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 Ceritinib (Zykadia®) 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 Ceritinib (Zykadia®)

Individual Drug Label Information

Ceritinib (Zykadia®)

  • Ceritinib is an oral capsule, only available in 150 mg strength 
  • Should be taken on an empty stomach, at least 2 hours before a meal or two hours after a meal. Food increases absorption so it is best to take on an empty stomach to avoid an increase in side effects. It can be taken at any time of the day as long as it is taken at the same time each day 
  • If you forget to take a dose, take the missed dose only if it has been less than 12 hours since the dose was due. If it has been more than 12 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 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 ceritinib. This could increase your risk of experiencing side effects. Avoid eating grapefruit and drinking anything containing grapefruit juice during treatment 
  • Avoid smoking and therapy with St. Johns Wort, as it will decrease blood levels of ceritinib and could decrease its effectiveness 
  • Avoid during pregnancy. Contact your doctor immediately if you think you may have become pregnant. 
  • Females who are of child bearing age should use contraception during treatment and for at least 2 weeks after stopping ceritinib 
General Ceritinib (Zykadia) Side Effects 
  • May slow the heart rate. Contact your doctor is you experience a slower resting heart rate or signs of a slow heart rate such as dizziness, lightheadedness, or fainting 
  • May increase risk for a rare, but serious heart arrhythmia. Electrocardiograms and blood electrolytes (potassium, magnesium, calcium) may be checked periodically to help keep the heart healthy
  • May cause severe diarrhea.
  • May increase blood sugar. Risk of experiencing high blood sugar increases in diabetic patients or those receiving oral or intravenous steroid medications such as prednisone or dexamethasone
  • Cough, shortness of breath, respiratory infections, and rare but serious lung injuries have been reported
  • Pancreatitis 
  • Severe liver injury 
  • May alter taste or decrease your appetite 
  • Constipation 
  • Headache 
  • Pain in your back, arms, and legs 
  • May cause fluid to accumulate, most commonly in the legs 
  • Mouth sores 
  • May cause fatigue or generalized weakness 
  • Click on the ceritinib (Zykadia) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

Shaw AT, Kim DW, Mehra R, et al. Ceritinib in ALK-rearranged non-small-cell lung cancer. N Engl J Med 2014;370:1189-1197.

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