About TASIGNA
TASIGNA® (nilotinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of TASIGNA is based on major molecular response and cytogenetic response rates. The study is ongoing and further data will be required to determine long-term outcome.
TASIGNA is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myeloid (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of TASIGNA is based on hematologic and cytogenetic response rates.
In people with Ph+ CML, the bone marrow (the soft tissue inside bones where blood cells are made) produces too many white blood cells and these cells are often immature or damaged. TASIGNA is thought to work at the source of Ph+ CML by blocking the signal that causes your body to produce too many white blood cells.
Ph+ CML happens when an abnormal gene, called BCR-ABL, produces an abnormal protein called Bcr-Abl, which then leads to abnormalities in your body's process for making blood cells. The Bcr-Abl protein acts like a switch that keeps your white-blood cell production in the "on" position. Your bone marrow keeps making damaged white blood cells that, over time, crowd out healthy red blood cells and platelets.
TASIGNA may bind to the Bcr-Abl protein, which may block the signal that leads to the production of leukemic cells. Blocking the signal may lead to the death of leukemic cells and may help provide room for healthy blood cells to grow.
Even when test results show that TASIGNA is working, you may have levels of the Bcr-Abl protein in your blood that are not detectable by blood and bone marrow tests. If you stop taking TASIGNA or change your dose without speaking with your doctor, the abnormal protein could lead to the production of more leukemic cells. This is why it is so important you keep taking TASIGNA exactly as prescribed.
How is TASIGNA different from GLEEVEC?
TASIGNA is thought to work similarly to GLEEVEC. GLEEVEC may bind to the Bcr-Abl protein, which may block the signal that causes your body to produce too many damaged white blood cells. However, over time, the Bcr-Abl protein can change or mutate. This can lead to GLEEVEC resistance, meaning that GLEEVEC no longer stops the signal that leads to the overproduction of damaged white blood cells. TASIGNA is thought to bind to some mutations of the Bcr-Abl protein that cause GLEEVEC resistance.
How TASIGNA Works
What is the most important information to know about 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 Indications
TASIGNA is a prescription medicine used to treat a type of leukemia called Philadelphia chromosome–positive chronic myeloid leukemia (Ph+ CML) in adults who:
- Are newly diagnosed with Ph+ CML in chronic phase (CP). The study is ongoing and further data will be required to determine long-term outcomes
- Are in chronic phase (CP) or accelerated phase (AP) Ph+ CML and are resistant or intolerant to prior therapy that included imatinib
Important Safety Information
Important Information about TASIGNA® (nilotinib)
It is not known if TASIGNA is safe or effective in children.
What is the most important information to know about 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
Taking TASIGNA:
- 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
Who should not take TASIGNA?
Do not take if you have:
- Low levels of potassium or magnesium in your blood
- Long QTc syndrome
TASIGNA is a prescription medication. TASIGNA comes in 150 mg and 200 mg capsules. Your doctor will prescribe 300 mg of TASIGNA to be taken twice a day for a total daily dose of 600 mg or 400 mg of TASIGNA to be taken twice a day for a total daily dose of 800 mg. Each dose should be taken approximately 12 hours apart.
Swallow TASIGNA capsules whole with water. If you cannot swallow TASIGNA capsules whole, tell your doctor.
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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.
Call your doctor right away if you faint or have an irregular heartbeat while taking TASIGNA.
These can be symptoms of QT prolongation.
Call your doctor immediately if you experience any of these symptoms.
Serious side effects
TASIGNA is sometimes associated with serious side effects, some symptoms of which include:
- Feeling lightheaded, fainting, or having an irregular heartbeat
- Unexplained bleeding or bruising
- Blood in urine or stool
- Unexplained weakness
- Yellow skin and eyes
- Shortness of breath
- Sudden stomach area pain with nausea and vomiting
- Sudden headache, changes in your eyesight, not being aware of what is going on around you, and becoming unconscious
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.
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.
Your doctor may have you stop TASIGNA for some time or reduce your dose if you have side effects with it.
Please see accompanying patient information, including Boxed WARNING, and the TASIGNA Medication Guide you received with your prescription.
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