Blood Testing and TASIGNA

Your blood demands to be monitored.

Monitoring matters when you have Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). Your doctor can only see how you’re responding to treatment by looking at the results of regular blood tests. Your blood counts should be checked every 2 weeks for the first 2 months and then monthly thereafter. Monitoring is a key part of your treatment. During treatment with TASIGNA^® (nilotinib) capsules your healthcare provider will do tests to check for side effects and to see how well TASIGNA is working for you.

Measuring response to your treatment

When you’re taking TASIGNA, you want to see the number of leukemic cells in your body go down. In addition to going for any blood work your doctor may require, it’s important to talk with your doctor about what your results mean.

Here are the tests your doctor will likely recommend, the types of response, and what you should ask your doctor. You can download the TASIGNA Treatment Guide to have a place to record the results of your blood work.

Complete blood count (CBC)

• What it tests: Counts the number of white blood cells, red blood cells, and platelets in the blood

• Type of response: Determines if the number of white blood cells, red blood cells, and platelets are within the normal range

• What to ask your doctor: Discuss your blood counts and record your results

Cytogenetic test

• What it tests: A sample of your bone marrow is removed and your doctor measures the number of cells with the Philadelphia chromosome

• Types of responses
  • Minor cytogenetic response: More than 35% of cells in the bone marrow are Ph+
  • Partial cytogenetic response (PCyR): 1% to 35% of cells in the bone marrow are Ph+
  • Complete cytogenetic response (CCyR): The number of cells in the bone marrow with Ph+ is undetectable

• What to ask your doctor: Discuss your cytogenetic results and record the percentage of Ph+ cells detected

Standardized polymerase chain reaction (PCR or molecular) test

The PCR test measures the number of cells that have the BCR-ABL1 gene. This abnormal gene creates a damaged protein called BCR-ABL. It causes the bone marrow to create leukemic cells. 

• What it tests: When the number of chronic myeloid leukemia (CML) cells is low, Philadelphia chromosome–positive (Ph+) cells may not be visible with a cytogenetic test. Only PCR testing is sensitive and clear enough to check for even the smallest amount of leukemic cells

• Types of responses
  • Early molecular response: The amount of the BCR-ABL1 gene in the body is less than or equal to (≤)10% at 3 months and 6 months after starting treatment. This means that no more than 1 out of every 10 cells has the BCR-ABL1 gene
  • Major molecular response (MMR): The amount of BCR-ABL1 in the body is ≤0.1%. This means that 1 out of every 1,000 cells or fewer has the BCR-ABL1 gene
  • Deep molecular response (DMR): The amount of BCR-ABL1 in the body is almost undetectable. Your doctor may call this MR4.5 (BCR-ABL1 ≤0.0032%). This means that 1 out of every 32,000 cells or fewer has the BCR-ABL1 gene
• What to ask your doctor: Discuss your PCR test results and record the percentage of BCR-ABL1 detected

Testing, talking, tracking

Of course, it’s not enough to get your blood tested. You need to discuss your results with your doctor, so you can track and understand your progress. To keep up with your blood work, be sure to download the TASIGNA Treatment Guide. 

Other tests your doctor will require

During treatment with TASIGNA your doctor will do tests to check for side effects. These tests will check your heart (electrocardiogram), blood cells (white blood cells, red blood cells, and platelets), electrolytes (potassium, magnesium), cholesterol, blood sugar, pancreas function, and liver function. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects. You should follow your doctor’s instructions.

Treatment-free remission

After taking TASIGNA for at least 3 years, your doctor may determine if you meet certain criteria to be eligible to try stopping treatment with TASIGNA. This is called treatment-free remission (TFR). If your doctor decides you are eligible to attempt TFR, you can expect an increase in the frequency of monitoring. Learn more about TFR.