nilotinib

What is the most important information I should know about nilotinib?

What is nilotinib?

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.

What should I discuss with my healthcare provider before taking nilotinib?

• 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.

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.

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

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.

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?

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.

What are the possible side effects of nilotinib?

• 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.

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.

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.

Where can I get more information?

Your pharmacist can provide more information about nilotinib.