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Treatment Name: Imatinib (Gleevec®)

Imatinib (Gleevec®) is a Chemotherapy Regimen for Chronic Myeloid Leukemia (CML)

How does Imatinib work?
Imatinib 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:
Imatinib is taken to reduce symptoms from Chronic Myeloid Leukemia (CML) or prevent them from ever occurring. Imatinib is usually taken for many years to prevent CML from progressing to more aggressive phases. Imatinib is not commonly given with the goal of cure, but all signs of the CML may become undetectable after taking it for one or more years.

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Schedule

Usual starting dose for chronic phase

  • Imatinib 400 mg, one oral tablet by mouth once daily, every day

Usual starting dose for accelerated phase, or blast phase:

  • Imatinib 600 mg, oral tablets by mouth once daily, every day (tablet combinatons vary to equal 600 mg)

Imatinib is dispensed by a pharmacy and taken at home. Some patients may require hospitalization when initially diagnosed and begin treatment with imatinib before leaving the hospital. Typical duration of therapy is usually 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 imatinib 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 Imatinib are shown here:

  • Water retention (56%)
  • Nausea (44%)
  • Muscle cramps (38%)
  • Bone pain (37%)
  • Fatigue (35%)
  • Skin rash (34%)
  • Diarrhea (33%)
  • Headache (31%)
  • Abdominal Pain (27%)
  • Common cold or other respiratory infection (up to 22%)
  • Bruising or bleeding (21%)
  • Vomiting (17%)
  • Upset stomach (16%)
  • Cough (15%)
  • Dizziness (15%)
  • Weight gain (13%)
  • Fever (13%)
  • Trouble sleeping (12%)
  • Itching (7%)

Some of the side effects listed may be due to CML, rather than Imatinib. Therefore, some of these side effects may go away with continued treatment. Severe side effects are rare and occur in less than 3% of patients. The percentage of patients that stopped using Imatinib due to unacceptable side effects is about 12%.

Side effect videos Side Effect Videos
Nausea and VomitingNausea and VomitingPainPainFatigue Fatigue DiarrheaDiarrheaBleedingBleedingAnemiaAnemiaNeutropenic FeverNeutropenic Fever

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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, then monthly until stable. Most patients achieve a complete hematologic (blood) response within 4 weeks of beginning therapy. 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 not usually seen after the first two weeks of therapy.

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

How do I know if I am responding to Imatinib?
It is important for you to know what your BCR/ABL% is. This way, if it begins to increase, you will know and 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 Imatinib 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 are not being met.

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ChemoExperts Tips

  • Imatinib is best taken with food to avoid heartburn and nausea. Patients with a history of heartburn should take it at least 2 hours before bedtime
  • A chemical in grapefruit juice, star fruit, and pomegranate can decrease the body’s ability to break down Imatinib and increase the drug amount in your body. This may lead to increased side effects, therefore it is best to avoid grapefruit, star fruit, and pomegranate
  • Daily weight should be monitored when beginning therapy. This will help determine if swelling in the legs needs to be treated with diuretics. Bring a journal with these daily weights to each clinic visit
  • Although rash is common, it is rarely severe. When rash occurs, it usually appears on the forearms, chest, abdominal area, and occasionally on the face. In most cases, therapy can be continued. Most rashes go away on their 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 make sure Imatinib can be taken safely with all your 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 Imatinib, 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 Imatinib (Gleevec®), 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 Imatinib (Gleevec®). Depending upon your income, they may be able to help cover the cost of:

  • Imatinib

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 Imatinib (Gleevec®) 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 Imatinib (Gleevec®)

Individual Drug Label Information

Imatinib (Gleevec®)

  • Imatinib is an oral tablet of either 100 mg or 400 mg  
  • It is usually taken with food and a large glass of water. Doses up to 600 mg may be taken once daily, but the 800 mg dose is best taken as 400 mg by mouth twice daily 
  • For patients unable to swallow tabs, they may be dissolved in apple juice. For example, a 400 mg tab may be mixed in 8 ounces of apple juice and then swallowed immediately after dissolving
  • A chemical in certain fruits such as: grapefruit, star fruit, and pomegranate decreases the body’s ability to break down Imatinib so it is best to avoid these 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
  • Store tablets at room temperature, 77°F (25°C)
  • Dosage adjustments may be required for severe liver or kidney problems, low white blood cells (neutrophils), low red blood cells, or low platelets
  • Women of child-bearing potential should avoid becoming pregnant, or taking this 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 balance this with Imatinib therapy
  • 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 Imatinib
General Imatinib (Gleevec) Side Effects
  • Water retention is common. Patients should weigh themselves daily and keep a journal to show their doctor, who may then prescribe diuretics (water pills) or recommend withholding treatment for a short time
  • Nausea, vomiting, & upset stomach may be minimized by taking with food
  • Muscle cramps can sometimes be treated with electrolytes such as potassium or magnesium prescribed by your doctor
  • Skin rash often resolves with continued treatment. Tell your doctor immediately if you develop a rash
  • Fatigue
  • Diarrhea often resolves with continued treatment
  • Bruising or bleeding; anemia
  • Fever may be a sign of infection. Keep a thermometer at home and report any fevers immediately
  • Trouble sleeping
  • Click on the imatinib (Gleevec) package insert below for reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue BleedingBleedingPainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

1. O’Brien SG, Guilhot F, Larson RA, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003;348:994-1004.

2. Guilhot F. Indications for Imatinib Mesylate Therapy and Clinical Management. Oncologist. 2004;9:271-281.

3. Marin D, Bazeos A, Mahon FX, et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol. 2010;28:2381-2388.

4. Larson RA. Is there a best TKI for chronic phase CML? Blood. 2015;126:2370-2375.

Created: August 29, 2015 Updated: September 5, 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 Blast Phase?

When a patient with CML has a bone marrow biopsy that shows more than 20% blasts, they are said to be in blast phase, or blast crisis. Patients with blast phase usually have symptoms similar to acute leukemia such as: easy bruising or bleeding, fever, poor appetite, weight loss, or an enlarged spleen.

Clinical Studies

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

1. O’Brien SG, Guilhot F, Larson RA, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med. 2003;348:994-1004.

2. Guilhot F. Indications for Imatinib Mesylate Therapy and Clinical Management. Oncologist. 2004;9:271-281.

3. Marin D, Bazeos A, Mahon FX, et al. Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. J Clin Oncol. 2010;28:2381-2388.

What is BCR/ABL?

A gene mutation within CML cells. The percent of cells that have the BCR/ABL mutation goes down by taking Imatinib therapy. The goal is that the percentage will become undetectable. This happens for 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 Imatinib.

Responding to Imatinib?

The optimal response to Imatinib 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 three months of Imatinib (without missing doses) may need to switch therapy to another medication that treats CML.

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

  • Newly Diagnosed (No Imatinib 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 are diuretics?

Diuretics are medicines used to make people urinate. They are usually taken to help get rid of excess water that the body is holding onto. Excess water weight usually appears as swelling in the extremities such as arms, legs, or feet. It can occur in other areas such as in the lungs or around the eyes.

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, 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.