Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML) in adults and children who are at least 1 year old.
Nilotinib is usually given after other treatments have failed.
Nilotinib may also be used for purposes not listed in this medication guide.
uses
What is Tasigna (Nilotinib) used for?
- Chronic Myelogenous Leukemia
warnings
What is the most important information I should know about Tasigna (Nilotinib)?
You should not use nilotinib if you are allergic to it, or if you have:
- low blood levels of potassium or magnesium; or
- a heart rhythm disorder called long QT syndrome.
Tell your doctor if you have ever had:
- heart disease, heartbeat problems, or long QT syndrome (in you or a family member);
- a stroke;
- blood circulation problems in your legs;
- bleeding problems;
- low blood levels of potassium or magnesium;
- severe problems with lactose (milk sugar);
- liver disease;
- pancreatitis; or
- surgical removal of your stomach (total gastrectomy).
You may need to have a negative pregnancy test before starting this treatment.
Do not use nilotinib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 14 days after your last dose.
Do not breastfeed while you are taking nilotinib and for at least 14 days after your last dose.
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Side Effects
What are the side effects of Tasigna (Nilotinib)?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Contact your doctor right away or get emergency medical help if you have symptoms of a serious heart problem: fast or pounding heartbeats and sudden dizziness (like you might pass out).
Call your doctor at once if you have:
- unusual bleeding (bruises, blood in your urine or stools);
- swelling, rapid weight gain, feeling short of breath;
- bleeding in the brain–sudden headache, confusion, vision problems, and dizziness;
- signs of liver or pancreas problems–upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, jaundice (yellowing of the skin or eyes);
- low blood cell counts–fever, chills, night sweats, mouth sores, pale skin, unusual weakness;
- signs of decreased blood flow–leg pain or cold feeling, chest pain, numbness, trouble walking, speech problems; or
- signs of tumor cell breakdown–confusion, weakness, muscle cramps, nausea, vomiting, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.
Nilotinib can affect growth in children and teenagers. Tell your doctor if your child is not growing at a normal rate while using this medicine.
Common side effects may include:
- nausea, vomiting, diarrhea, constipation;
- rash, temporary hair loss;
- night sweats;
- pain in your bones, spine, joints, or muscles;
- headache, feeling tired; or
- runny or stuffy nose, sneezing, cough, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Pregnancy & Breastfeeding
Can I take Tasigna (Nilotinib) if I’m pregnant or breastfeeding?
You may need to have a negative pregnancy test before starting this treatment.
Do not use nilotinib if you are pregnant. It could harm the unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 14 days after your last dose.
Do not breastfeed while you are taking nilotinib and for at least 14 days after your last dose.
Interactions
What drugs and food should I avoid while taking Tasigna (Nilotinib)?
Grapefruit may interact with nilotinib and lead to unwanted side effects. Avoid the use of grapefruit products.
Avoid taking a stomach acid reducer (such as Pepcid, Tagamet, or Zantac) within 10 hours before or 2 hours after you take nilotinib.
Avoid taking an antacid that contains aluminum, magnesium, or simethicone (such as Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, or Rolaids) within 2 hours before or 2 hours after you take nilotinib.
Dosage Guidelines & Tips
How to take Tasigna (Nilotinib)?
Use Tasigna (Nilotinib) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.
Nilotinib is usually taken every 12 hours. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Take nilotinib on an empty stomach. Do not take with food. Food can increase your blood levels of nilotinib and may increase harmful side effects.
Avoid eating anything for at least 2 hours before and 1 hour after you take nilotinib.
Take this medicine with a full glass of water. Swallow the capsule whole.
If you cannot swallow a capsule whole, open it and sprinkle the medicine into a teaspoon of applesauce. Swallow the mixture right away without chewing. Do not save it for later use.
Nilotinib is to be taken long-term. You should not stop using nilotinib unless your doctor tells you to.
Nilotinib can lower your blood cell counts. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.
Nilotinib can cause a serious heart problem. Your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG) before and during your treatment with nilotinib.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Overdose Signs
What happens if I overdose on Tasigna (Nilotinib)?
Overdose symptoms may include drowsiness and vomiting.
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Images
NVR, BCR
Color: red
Shape: capsule
Imprint: NVR, BCR
NVR, TKI
Color: yellow
Shape: capsule
Imprint: NVR, TKI
NVR ABL
Color: red/yellow
Shape: capsule
Imprint: NVR ABL