Monitoring Ph+ CML
Periodic testing is an important part of treatment.
A key goal of treatment with TASIGNA 150-mg or 200-mg capsules is to eliminate or reduce the number of cells containing the abnormal chromosome that causes Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Your doctor will recommend several types of laboratory tests to help monitor whether or not you are responding to your TASIGNA treatment and for possible TASIGNA-related side effects.
It is important that your response to TASIGNA is checked periodically. The 3 main kinds of tests used to monitor how well you are responding to your medication are:
- Hematologic tests
- Cytogenetic tests
- Molecular tests
These tests involve taking blood or bone marrow samples. Each test looks at a different level of response to treatment, with increasing sensitivity. Your doctor uses these tests to help manage your disease and decide if treatment changes are needed. Your doctor may recommend you are monitored every 3 months using all or some of these tests.
Hematologic Tests
A hematologic test is a simple blood test. A sample of blood is taken (usually from a vein in your arm), and then the laboratory counts the number of white blood cells, red blood cells, and platelets in the blood sample. If your blood cell counts have returned to within the normal range, you have achieved what is called a complete hematologic response. This does not mean, however, that your Ph+ CML is cured.
However, even when your blood cell counts return to normal, your doctor may recommend other, more specific tests to monitor your progress. To help keep your blood cell counts within the normal range, it is very important you continue taking your TASIGNA exactly as directed by your doctor.
Cytogenetic Tests
In cytogenetic testing, laboratory technicians look at samples of your bone marrow or blood under a microscope and count the number of cells that contain the Ph chromosome. If no cells with the Ph chromosome are found, it is called a complete cytogenetic response. This does not mean, however, that your Ph+ CML is cured.
Even when cytogenetic tests find no cells containing the Ph chromosome, you can still have abnormal white blood cells containing the Ph chromosome in your body that cannot be detected by cytogenetic testing. To help prevent these low levels of white blood cells from increasing again, you should continue taking your TASIGNA exactly as directed by your doctor.
Complete cytogenetic response:
No (0%) cells in the sample have the Ph chromosome
Partial cytogenetic response:
1-34% of cells in the sample (1-34 out of 100) have the Ph chromosome
There are 2 types of cytogenetic tests:
- Karyotyping—looks at a small number of bone marrow cells and white blood cells (20 to 25) to count how many contain the Ph+ chromosome
- FISH (fluorescence in situ hybridization)—performed on either blood or bone marrow cells, this test looks for abnormal cells that contain the abnormal BCR-ABL gene, which is located on the Ph chromosome. This test can find 1 abnormal cell out of a background of up to 500 normal cells
If you have a complete cytogenetic response your physician may order another, even more sensitive test to determine your molecular response to treatment.
Molecular Tests
The most sensitive kind of test that is currently available for monitoring the response to treatment for Ph+ CML is called a Q-RT-PCR (quantitative reverse transcription-polymerase chain reaction). Q-RT-PCR requires a sample of blood or bone marrow, and it can detect a single abnormal cell containing the Bcr-Abl protein in up to 1 million normal cells.
Only your doctor can decide which tests are right for you in monitoring your Ph+ CML. Work closely with your doctor to monitor your progress. It is important that you don't change the amount of TASIGNA you take or stop taking it without talking to your doctor first. Being aware of how you are responding to treatment can help you and your doctor continue to manage your condition.
What Does Intolerant Mean?
TASIGNA is indicated for adult patients with Ph+ CML in chronic or accelerated phase who are resistant to or intolerant of imatinib mesylate.
What is the most important information to know about prescription TASIGNA?
TASIGNA can cause a possible life-threatening heart problem called QT prolongation.
QT prolongation causes an irregular heartbeat, which may lead to sudden death.
Your doctor should check your heart with a test called an electrocardiogram (ECG):
- Before starting TASIGNA
- 7 days after starting TASIGNA
- With any dose changes
- Regularly during TASIGNA treatment
TASIGNA® (nilotinib) Indications
TASIGNA is a prescription medicine used to treat adults with newly diagnosed Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The efficacy of TASIGNA is based on major molecular response and cytogenetic response rates. The study is on-going and more data will be needed to determine long-term outcomes.
TASIGNA is also used to treat chronic phase or accelerated phase Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who are no longer benefiting from previous other treatments, including imatinib (GLEEVEC), or have taken other treatments, including imatinib (GLEEVEC) but cannot tolerate them. The efficacy of TASIGNA is based on hematologic response and cytogenetic response rates.
IMPORTANT SAFETY INFORMATION ABOUT TASIGNA® (nilotinib)
What is the most important information to know about prescription TASIGNA?
TASIGNA can cause a possible life-threatening heart problem called QT prolongation.
QT prolongation causes an irregular heartbeat, which may lead to sudden death.
Your doctor should check your heart with a test called an electrocardiogram (ECG):
- Before starting TASIGNA
- 7 days after starting TASIGNA
- With any dose changes
- Regularly during TASIGNA treatment
You may lower your chances for having QT prolongation with TASIGNA if you:
- Take TASIGNA on an empty stomach
- DO NOT TAKE TASIGNA WITH FOOD
- Food can affect the levels of TASIGNA in your body, which can lead to serious side effects
- Taking TASIGNA on an empty stomach may lower your chances of having a possibly life-threatening heart problem called QT prolongation
- QT prolongation causes an irregular heartbeat, which may lead to sudden death
Who should not take TASIGNA?
Do not take if you have:
- Low levels of potassium or magnesium in your blood
- Long QTc syndrome
Taking TASIGNA:
- TASIGNA should be taken exactly as instructed by your doctor. Do not change the dose or stop taking TASIGNA unless instructed to by your doctor.
- Take TASIGNA at least 2 hours after eating any food
- After taking TASIGNA, wait at least 1 hour before eating any food
-
Avoid grapefruit, grapefruit juice, and any supplement containing grapefruit extract while taking TASIGNA.
Food and grapefruit products increase the amount of TASIGNA in your body
- Avoid taking other medicines or other supplements with TASIGNA that can also cause QT prolongation
- Swallow TASIGNA capsules whole with water. If you cannot swallow TASIGNA capsules whole, tell your doctor
-
If you cannot swallow TASIGNA capsules whole:
- Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple)
- Do not use more than 1 teaspoon of applesauce
- Only use applesauce. Do not sprinkle TASIGNA onto other foods
- Swallow the mixture right away (within 15 minutes)
- Open the TASIGNA capsules and sprinkle the contents in 1 teaspoon of applesauce (puréed apple)
- Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. It may affect the levels of TASIGNA in the blood
- If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a missed dose
Before taking TASIGNA
Talk to your doctor or pharmacist about all other medication(s) you may be taking, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements, since they may affect how TASIGNA works and increase your chance of serious and life-threatening side effects.
Tell your doctor if:
- You have a heart disorder or are taking medication for the heart
- You have an irregular heartbeat
- You have QT prolongation or a family history of it
- You have liver problems
- You know that you suffer from low blood levels of electrolytes, such as potassium, magnesium, or calcium
- You have a pancreas disorder
- You have had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
Also tell your doctor if you are pregnant, breast-feeding, or lactose-intolerant. The TASIGNA capsules contain lactose. Most patients who have mild or moderate lactose intolerance can take TASIGNA.
Serious side effects
TASIGNA may cause serious side effects including:
- QT prolongation. Call your doctor right away if you feel lightheaded, faint or have an irregular heartbeat while taking TASIGNA. These can be symptoms of QT prolongation, a possible life-threatening heart problem
-
Low blood counts. Low blood counts are common with TASIGNA. Your doctor will check your blood counts regularly during treatment with TASIGNA. Symptoms of low blood counts include:
- Unexplained bleeding or bruising
- Blood in urine or stool
- Unexplained weakness
- Shortness of breath
- Liver damage. Symptoms include yellow skin and eyes
- Pancreas inflammation (pancreatitis). Symptoms include sudden stomach area pain with nausea and vomiting
- Bleeding in the brain. Symptoms include sudden headache, changes in your eyesight, not being aware of what is going on around you and becoming unconscious
-
Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have:
- kidney failure and the need for dialysis treatment
- an abnormal heart beat
Your doctor may do blood tests to check you for TLS
Call your doctor immediately if you experience any of these symptoms. Your doctor may change your dose. Your doctor may have you stop TASIGNA for some time or lower your dose if you have side effects with it.
Common side effects
Most patients experience side effects at some time. Some common side effects you may experience include:
- Low blood count
- Rash
- Nausea
- Fever
- Stomach (abdominal) pain
- Headache
- Itching
- Muscle and joint pain
- Tiredness
- Diarrhea
- Constipation
- Back pain
- Muscle spasms
- Weakness
- Hair loss
- Runny or stuffy nose, sneezing, sore throat
- Cough
Be sure to tell your doctor or pharmacist if you have any side effects during treatment with TASIGNA. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
It is not known if TASIGNA is safe or effective in children.
Tell your doctor if you are pregnant or planning to become pregnant. TASIGNA may harm your unborn baby. If you are able to become pregnant, you should use effective birth control during treatment with TASIGNA. Talk to your doctor about the best birth control methods to prevent pregnancy while you are taking TASIGNA.
Tell your doctor if you are breast-feeding or plan to breast-feed. It is not known if TASIGNA passes into your breast milk. You and your doctor should decide if you will take TASIGNA or breast-feed. You should not do both.
If you take too much TASIGNA, call your doctor or poison control center right away.
Your doctor will check your heart, do regular blood tests, and take bone marrow samples during treatment with TASIGNA. These are done to check for side effects with TASIGNA and to see how well TASIGNA is working for you. Your doctor should check your blood to monitor the amount of blood cells (white blood cells, red blood cells, and platelets) during treatment. These should be checked every 2 weeks for the first 2 months and then monthly thereafter, or as considered necessary by your doctor.
Please see the full prescribing information including the Boxed WARNING, and the TASIGNA Medication Guide.
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