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.

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.

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.

Usual Adult Dose for Chronic Myelogenous Leukemia:

Newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP): 300 mg orally twice a day
Resistant or intolerant Ph+ CML-CP and chronic myeloid leukemia in accelerated phase (CML-AP): 400 mg orally twice a day

Comments:
-Doses should be administered about 12 hours apart.
-This drug may be given in combination with hematopoietic growth factors (e.g., erythropoietin, granulocyte colony-stimulating factor [G-CSF]), hydroxyurea, or anagrelide if clinically indicated.

Uses:
-For the treatment of patients with newly diagnosed Ph+ CML-CP
-For the treatment of patients with chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant/intolerant to prior therapy that included imatinib

Usual Pediatric Dose for Chronic Myelogenous Leukemia:

1 year or older: 230 mg/m2 orally twice a day
-Rounded to the nearest 50 mg dose
-Maximum dose: 400 mg/dose

Dosing based on BSA:
-BSA up to 0.32 m2: 50 mg orally twice a day
-BSA 0.33 to 0.54 m2: 100 mg orally twice a day
-BSA 0.55 to 0.76 m2: 150 mg orally twice a day
-BSA 0.77 to 0.97 m2: 200 mg orally twice a day
-BSA 0.98 to 1.19 m2: 250 mg orally twice a day
-BSA 1.2 to 1.41 m2: 300 mg orally twice a day
-BSA 1.42 to 1.63 m2: 350 mg orally twice a day
-BSA at least 1.64 m2: 400 mg orally twice a day

Comments:
-Doses should be administered about 12 hours apart.
-Therapy should be continued as long as clinical benefit is observed or until unacceptable toxicity occurs.
-This drug may be given in combination with hematopoietic growth factors (e.g., erythropoietin, G-CSF), hydroxyurea, or anagrelide if clinically indicated.

Uses:
-For the treatment of patients with newly diagnosed Ph+ CML-CP
-For the treatment of patients with chronic phase and accelerated phase Ph+ CML with resistance or intolerance to prior tyrosine-kinase inhibitor therapy

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 breastfeed while you are taking nilotinib and for at least 14 days after your last 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.

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

Overdose symptoms may include drowsiness and vomiting.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit, drink grapefruit juice, or take any supplement containing grapefruit extract while taking this medication.

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.

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).

Nilotinib may cause serious side effects. 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 nilotinib.

Common side effects of nilotinib 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.

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.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.