Nilotinib capsules

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.
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.