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Treatment Name: Nilotinib (Tasigna®)

Nilotinib (Tasigna®) is a Chemotherapy Regimen for Chronic Myeloid Leukemia (CML)

How does nilotinib work?
Nilotinib is designed to stop cancerous white blood cells from growing and dividing. It may also permit non-cancerous blood cells in the bone marrow to grow normally.

Goals of therapy:
Nilotinib is taken to reduce symptoms from Chronic Myeloid Leukemia (CML) or prevent them from ever occurring. Nilotinib is not usually a cure, and is usually taken for many years to prevent CML from progressing to more aggressive phases. All signs of CML may become undetectable after taking it for one or more years.

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Schedule

Usual starting dose for newly diagnosed chronic phase

  • Nilotinib 300 mg (two 150 mg) oral capsules by mouth TWICE daily, every day without food
    • Nilotinib is best taken WITHOUT food, on an empty stomach. No food should be eaten for two hours before or until one hour after each dose. Food in the stomach increases the absorption of nilotinib, which may increase the risk of side effects
    • It is OK to take nilotinib with water

Usual starting dose for resistant/intolerant chronic phase or accelerated phase:

  • Nilotinib 400 mg (two 200 mg) oral capsules by mouth TWICE daily, every day without food
    • Nilotinib is best taken WITHOUT food, on an empty stomach. No food should be eaten for two hours before or until one hour after each dose. Food in the stomach increases the absorption of nilotinib, which may increase the risk of side effects 
    • It is OK to take nilotinib with water

Nilotinib is usually dispensed by a pharmacy and taken at home. Some patients may require hospitalization when initially diagnosed and begin treatment with nilotinib before leaving the hospital. Typical duration of therapy is life-long.

It is important that you do not miss doses, unless your doctor specifically says that this is okay. Missing doses may prevent you from achieving a remission and increase the risk of nilotinib no longer working.

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

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Side Effects

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

Severe side effects are rare and occur in less than 3% of patients.

Some of the side effects listed may be due to CML, rather than nilotinib. Therefore, some of these side effects may go away with continued treatment. The percentage of patients that stopped using nilotinib due to unacceptable side effects is about 5% for those taking 300 mg twice daily, and 9% for those taking 400 mg twice daily.

Certain side effects were more common with imatinib (Gleevec®), than nilotinib, such as: nausea, diarrhea, vomiting, muscle spasm, water retention or swelling.

Certain side effects were more common with nilotinib than imatinib (Gleevec®), such as: rash, headache, itching, and hair thinning (usually not complete hair loss).

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingHair LossHair LossFatigue Fatigue PainPainDiarrheaDiarrhea

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Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before treatment, once weekly during the first month, then every other week during the second month, and then monthly until stable. Most patients achieve a complete hematologic (blood) response within four weeks of beginning therapy with nilotinib. Labs at diagnosis often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), Lactate Dehydrogenase (LDH), magnesium, phosphorous, uric acid, plus any others your doctor may order. Tumor lysis syndrome is usually not seen after the first two weeks of therapy.

Additionally, a simple test known as an electrocardiogram (called "ECG", or "EKG") is often performed before you start treatment to make sure your heart rhythm is normal and it stays that way while receiving nilotinib. It is recommneded that an ECG is repeated roughly 7 days after starting or after any increase in dose to make sure your heart's ryhthm has not changed. Maintaining normal potassium and magnesium concentrations in your blood may help to prevent heart-related problems.

Importantly, your doctor will order a test known as BCR/ABL. Your doctor uses the BCR/ABL percentage (%) to monitor your response to nilotinib.

How do I know if I am responding to Nilotinib?
It is important for you to know what your BCR/ABL% is. This way, if it begins to increase you can look for reasons why. Missed doses and drug interactions are the most common reasons for an increasing BCR/ABL%.

How often is imaging needed?
Imaging may be checked before treatment, and periodically thereafter. Imaging may include: a chest X-ray, or CT scan of the lungs. These are most often done to look for an infection causing pneumonia.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to interrupt nilotinib therapy for a short period of time (several days), increase the dose if the BCR/ABL% is increasing, decrease the dose if the normal blood cells are too low, or switch therapy if goals of therapy are not being met.

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ChemoExperts Tips

  • A chemical in grapefruit juice, star fruit, and pomegranate can block the body’s ability to break down nilotinib and increase the levels in your body. This may lead to an an increase in side effects, therefore it is best to avoid these foods
  • Nilotinib is best taken without food, on an empty stomach. No food should be eaten for two hours before or one hour after taking a dose. Food in the stomach increases the absorption, which may increase the risk of side effects
  • Antacids or proton-pump inhibitors, such as omeprazole (Prilosec®), may decrease the amount of nilotinib that can be absorbed which may decrease its effectiveness. Tell your doctor if you take medications that affect stomach acid
  • Although rash is common, it is rarely severe. When rash occurs, it usually appears on the forearms, chest, abdominal (stomach) area, and occasionally on the face. In most cases, therapy with nilotinib can be continued and the rash will go away on its own or with topical creams or lotions recommended by your doctor
  • Bring all of your pill bottles to every clinic visit! This will make it easier for your healthcare team to monitor nilotinib safely with all other medications. A pharmacist should ALWAYS review your medication list to ensure drug interactions are prevented or managed appropriately
  • If you are having trouble paying for nilotinib, there are many patient assistance programs available to help. Ask your doctor or pharmacist to help you with this before you run out!
  • Clinical trials may exist for CML. 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 Nilotinib (Tasigna®), 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 Nilotinib (Tasigna®). Depending upon your income, they may be able to help cover the cost of:

  • Nilotinib

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 Nilotinib (Tasigna®) 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 Nilotinib (Tasigna®)

Individual Drug Label Information

Nilotinib (Tasigna®)

  • Nilotinib is an oral capsule that comes in either a 150 mg or 200 mg capsule. It is usually dispensed in “blister packs,” and not a bottle. Typically, a 28-day supply is given each month, totalling 112 capsules 
  • Nilotinib should be taken on an empty stomach. It is best to avoid eating at least one hour after a dose and at least two hours before a dose, unless instructed otherwise by a doctor or pharmacist. It may be taken with a large glass of water  
  • For patients unable to swallow capsules, the contents of each capsule may be dispersed in one teaspoon of applesauce 
  • A chemical in grapefruit juice decreases the body’s ability to break down nilotinib so it is best to avoid grapefruit and grapefruit juice to help prevent an increase in side effects 
  • If you miss a dose, take the next scheduled dose at the regular time. Do not take two doses at the same time 
  • Nilotinib should be stored at room temperature  
  • Dosage adjustments may be required for severe liver or kidney problems, or for low: white blood cells (neutrophils), red blood cells, or platelets 
  • Women of child-bearing potential should avoid becoming pregnant while taking nilotinib or taking it in the first trimester of pregnancy as it may harm the unborn baby. Women wanting to become pregnant should consult their doctor regarding the safest way to approach pregnancy 
  • May interact with a steroid known as dexamethasone (Decadron), or a variety of anti-seizure medicines. A dosage increase is sometimes required to avoid losing response to nilotinib  
  • Nilotinib may alter the heart’s rhythm. An echocardiogram is recommended before treatment to make sure it is safe to take. Your doctor may prescribe potassium or magnesium if your blood levels are low to help keep your heart functioning normally 
General Nilotinib (Tasigna) Side Effects  
  • Skin rash-- often resolves with continued treatment. Tell your doctor immediately if you develop a rash
  • Headache may vary in frequency and severity 
  • Nausea-- can often be managed with anti-nausea medications. Vomiting is rare  
  • Hair Loss is usually mild and is more accurately described as hair thinning. It may be more common at higher doses 
  • Muscle cramps or spasms can sometimes be treated with electrolytes such as potassium or magnesium prescribed by your doctor 
  • Itching 
  • Fatigue 
  • Diarrhea becomes less frequent with continued treatment. Diarrhea is usually managed using over-the-counter medications such as loperamide (Imodium®) 
  • Water retention, unlike imatinib (Gleevec), is rare  
  • Click on the nilotinib (Tasigna) package insert below for reported side effects and possible drug interactions

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

See DailyMed package insert.

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References

Saglio G, Kim DW, Issaragrisil S, et al. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia. N Engl J Med. 2010;362:2251-2259.

Created: August 30, 2015 Updated: September 6, 2018

What is Chronic Myeloid Leukemia (CML)?

A disease of the white blood cells found in the bone marrow that results when 2 chromosomes trade small sections of their DNA forming what is known as the “Philadelphia Chromosome.” When this happens within a white blood cell, it may grow and divide without being able to stop.

CML is a relatively rare condition and represents about 10% of diagnosed leukemias. CML is not thought to be an inherited disorder and most of the time, the cause is unknown. The average age at diagnosis is about 65 years old.

CML can present in one of three phases: Chronic Phase, Accelerated Phase, or Blast Crisis

Without treatment, CML may evolve over time causing aggressive disease. This may lead to symptoms such as weight loss, abdominal discomfort, decreased appetite, fever, bruising or bleeding, among others. The stage of CML can vary at diagnosis and throughout treatment. The effectiveness of the treatment may depend upon the phase of CML 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 Chronic Phase?

When a patient with CML has a bone marrow biopsy that shows less than 10% blasts, they are said to be in chronic phase. Patients in chronic phase have few or no symptoms from CML.

What is Accelerated Phase?

When a patient with CML has a bone marrow biopsy that shows between than 11 – 20% blasts, they are said to be in accelerated phase. Patients with accelerated phase usually have symptoms such as poor appetite, weight loss, an enlarged spleen, or fever.

What is BCR/ABL?

A gene mutation within CML cells. The percent of cells that have the BCR/ABL mutation goes down by taking nilotinib therapy. The goal is that the percentage will become undetectable. This happens in the many patients and is known as a complete molecular response, or 0.000%. At diagnosis, the BCR/ABL % is often very high, sometimes exceeding 100%. This is because the test is based upon the average BCR/ABL% from patients in one of the earliest clinical studies with imatinib. Having a BCR/ABL% greater than 100% at diagnosis does not usually affect the response to nilotinib.

Responding to Nilotinib?

The optimal response to nilotinib depends upon how long you have been taking it for. Ultimately, the goal is an undetectable BCR/ABL%, or 0.0000%, but a level less than 1% usually predicts long-term survival as well. Patients who have a BCR/ABL of 10% or more after 3 months of nilotinib (without missing doses) may need to switch therapy to another medication that treats CML.

Goal BCR/ABL% (International Scale, IS) while taking Nilotinib therapy:

  • Newly Diagnosed (No Nilotinib therapy): [~80 - more than 100%]
  • Complete Hematologic Response (CHR): Less than 10%
  • Complete Cytogenetic Response (CCyR): Less than 1%
  • Major Molecular Response (MMR): Less than 0.1%
  • Complete Molecular Response (CMR): 0.0000%

What is Tumor Lysis Syndrome?

Tumor lysis syndrome occurs when many cancer cells die quickly and release their contents into the bloodstream. Many times the body has the ability to flush these substances out through the kidneys or metabolize them via the liver. However, sometimes the body needs medicines to help eliminate these substances and to prevent organ damage.

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

What does "Cure" mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, doctors use the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.