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Nilotinib

Generic Name: nilotinib (nye LOE ti nib)
Brand Name: Tasigna

Medically reviewed on Aug 27, 2018

What is nilotinib?

Nilotinib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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 medications have been tried without success.

Nilotinib may also be used for purposes not listed in this medication guide.

Important Information

You should not use nilotinib if you have long QT syndrome, or low blood levels of potassium or magnesium.

Nilotinib can cause a serious heart problem, especially if you use certain other medicines at the same time. Tell your doctor about all your other medicines. Your heart function may need to be checked before and during treatment with nilotinib.

Call your doctor right away or get emergency medical help if you have fast or pounding heartbeats and sudden dizziness (like you might pass out).

Avoid eating anything for at least 2 hours before and 1 hour after you take nilotinib.

Before taking this medicine

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 nilotinib and for at least 14 days after your last dose.

Do not breast-feed while you are taking nilotinib and for at least 14 days after your last dose.

How should I take nilotinib?

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, at least 1 hour before or 2 hours after a meal. Do not take with food. Food can increase your blood levels of nilotinib and may increase harmful side effects.

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.

Avoid eating anything for at least 2 hours before and 1 hour after you take nilotinib.

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.

What happens if I miss a dose?

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.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness and vomiting.

What should I avoid while taking 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.

Nilotinib can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Nilotinib side effects

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. Tell your doctor if your child is not growing at a normal rate while using nilotinib.

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.

Nilotinib dosing information

Usual Adult Dose for Chronic Myelogenous Leukemia:

Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ CML):
-Newly Diagnosed in Chronic Phase (Ph+ CML-CP): 300 mg orally twice a day, approximately 12 hours apart
-Resistant or Intolerant in Chronic Phase and Accelerated Phase (Ph+ CML-CP and Ph+ CML-AP): 400 mg orally twice a day, approximately 12 hours apart

Comments:
-This drug should be taken on an empty stomach; no food should be consumed for at least 2 hours before the dose and for at least 1 hour after the dose is taken.
-This drug may be given in combination with hematopoietic growth factors (e.g., erythropoietin or G-CSF), hydroxyurea, or anagrelide if clinically indicated.

Uses:
-For newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
-For chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included imatinib

Usual Pediatric Dose for Chronic Myelogenous Leukemia:

1 year and older:
Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ CML):
-Newly Diagnosed in Chronic Phase (Ph+ CML-CP) or Resistant or Intolerant in Chronic Phase and Accelerated Phase (Ph+ CML-CP and Ph+ CML-AP): 230 mg/m2 (rounded to the nearest 50 mg dose [to a maximum single dose of 400 mg]) orally twice a day, approximately 12 hours apart; continue if clinical benefit is observed or until unacceptable toxicity occurs

Comments:
-This drug should be taken on an empty stomach; no food should be consumed for at least 2 hours before the dose and for at least 1 hour after the dose is taken.
-This drug may be given in combination with hematopoietic growth factors (e.g., erythropoietin or G-CSF), hydroxyurea, or anagrelide if clinically indicated.

Uses:
-For pediatric patients 1 year or older with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
-For pediatric patients 1 year or older with chronic phase Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) with resistance or intolerance to prior tyrosine-kinase inhibitor (TKI) therapy

What other drugs will affect nilotinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Nilotinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect nilotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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