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Pronunciation:nye LOE ti nib

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

donotYou should not use nilotinib if you are allergic to it, or if you have low blood levels of potassium or magnesium, or a history of Long QT syndrome.

Before using nilotinib, tell your doctor if you have heart disease or a heart rhythm disorder, liver disease, a personal history of pancreatitis, a family history of Long QT syndrome, or if your stomach has been surgically removed (total gastrectomy).

donotThere may be other drugs that could interact with nilotinib, or some that should not be used at the same time. Tell your doctor about all other medications you use.

Do not use this medication without telling your doctor if you are pregnant or breast-feeding a baby.

While using nilotinib, you may need frequent blood tests at your doctor's office.

Call your doctor at once if you have a serious side effect such as feeling light-headed with a fast or pounding heartbeat, pale skin, easy bruising or bleeding, fever, flu symptoms, cough with stabbing chest pain, mouth sores, feeling light-headed or short of breath, swelling, sudden headache or vision problems, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

What is nilotinib?

Nilotinib interferes with the growth of some cancer cells.

Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML).

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

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

donotYou should not use nilotinib if you are allergic to it, or if you have:
  • low blood levels of potassium or magnesium; or
  • a history of long QT syndrome.

To make sure nilotinib is safe for you, tell your doctor if you have any of these conditions:

  • heart disease;
  • a personal or family history of Long QT syndrome;
  • liver disease;
  • a personal history of pancreatitis; or
  • if your stomach has been surgically removed (total gastrectomy).
nopregFDA pregnancy category D. Do not use nilotinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.
nobrfeedIt is not known whether nilotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking nilotinib.

Nilotinib capsules may contain lactose. Talk to your doctor before using this medication if you have galactose intolerance, or severe problems with lactose (milk sugar).

How should I take nilotinib?

Nilotinib is usually taken every 12 hours. Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

icon26Take nilotinib on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take with food.
waterTake this medicine with a full glass of water.
nocrushSwallow the nilotinib capsule whole.

To make swallowing easier, you may open the nilotinib capsule and sprinkle the medicine into 1 teaspoon of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

emtYou will need frequent medical tests at your doctor's office to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.
donotDo not stop using nilotinib or change your dose without talking to your doctor. If you stop taking the medication too soon, your condition may get worse.
rtStore at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

emtSeek 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?

donotDo not take with food. Food can increase your blood levels of nilotinib and may increase your risk of harmful side effects.

Grapefruit and grapefruit juice may interact with nilotinib and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

Avoid taking an antacid within several hours before or after you take nilotinib.

What are the possible side effects of nilotinib?

emtGet emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
donotStop using nilotinib and call your doctor at once if you have a serious side effect such as:
  • headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, weakness, easy bruising or bleeding;
  • blood in your urine or stools;
  • severe pain in your upper stomach spreading to your back;
  • nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • lower back pain, numbness or tingly feeling around your mouth;
  • urinating less than usual or not at all;
  • muscle weakness, tightness, or contraction;
  • fast or slow heart rate, weak pulse, feeling short of breath; or
  • sudden severe headache, confusion, problems with vision, feeling like you might pass out.

Other common side effects may include:

  • diarrhea, constipation;
  • mild skin rash, temporary hair loss;
  • headache, back pain, joint or muscle pain;
  • tired feeling; or
  • cold symptoms such as 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?

Many drugs can interact with nilotinib and not all possible interactions are listed in this medication guide. Tell your doctor about all medications you use, and those you start or stop using during your treatment with nilotinib, especially:

  • esomeprazole (Nexium) and other stomach acid reducers;
  • ergotamine (Ergomar, Cafergot) or dihydroergotamine (D.H.E. 45, Migranal Nasal Spray);
  • St. John's wort;
  • theophylline (Aquaphyllin, Asmalix, Elixophyllin, Theolair, Theosol);
  • a blood thinner or medication to prevent blood clots;
  • an antibiotic, or tuberculosis medicine;
  • antifungal medication;
  • anti-malaria medication;
  • cancer medication, an immunosuppressant, or medicine to prevent organ transplant rejection;
  • heart or blood pressure medication, heart rhythm medication;
  • medications to treat HIV, AIDS, or hepatitis C;
  • medicine to treat depression or mental illness;
  • medicine to treat or prevent nausea;
  • narcotic pain medication, a sedative, or a medication to treat narcolepsy;
  • seizure medication; or
  • steroid medication.

This list is not complete and many other drugs can interact with nilotinib. This includes prescription, over-the-counter, vitamin, and herbal products. Give a list of all your medicines to any healthcare provider who treats you

Where can I get more information?

Your pharmacist can provide more information about nilotinib.

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.

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