Nilotinib

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About This Drug

Nilotinib is used to treat cancer. It is given orally (by mouth).

Possible Side Effects

  • Bone marrow depression. This is a decrease in the number of white blood cells, red blood cells, and platelets. This may raise your risk of infection, make you tired and weak (fatigue), and raise your risk of bleeding.
  • Fever
  • Night sweats
  • Headache
  • Tiredness
  • Inflammation of the nasal passages and throat
  • Cough
  • Nausea and throwing up (vomiting)
  • Loose bowel movements (diarrhea)
  • Constipation (unable to move bowels)
  • Joint, bone and muscle pain
  • Arm or leg pain
  • Rash
  • Itching

Note: Each of the side effects above was reported in 20% or greater of patients treated with nilotinib. Not all possible side effects are included above.

Warnings and Precautions

  • Severe bone marrow depression
  • Blood clots and events such as stroke and heart attack.A blood clot in your leg may cause your leg to swell, appear red and warm, and/or cause pain. A blood clot in your lungs may cause trouble breathing, pain when breathing, and/or chest pain.
  • Abnormal heart beat and/or EKG which rarely can be life-threatening
  • Abnormal bleeding which can very rarely be life-threatening – symptoms may be coughing up blood, throwing up blood (may look like coffee grounds), red or black tarry bowel movements, abnormally heavy menstrual flow, nosebleeds or any other unusual bleeding
  • Fluid retention, you may have swelling of your legs, ankles and/or feet, trouble breathing because of fluid build-up in your lungs and/or your heart
  • Inflammation of your pancreas
  • Changes in your liver function
  • Electrolyte changes
  • This medication capsule contains lactose. Speak to your health care team if you have a severe lactose intolerance.
  • Tumor lysis syndrome: this drug may act on the cancer cells very quickly. This may affect how your kidneys work.
  • There is very rare increased risk of sudden death
  • Specific patients may be able to discontinue treatment only upon medical advice and continued monitoring.
  • Drug and food interactions may increase the risk of serious adverse effects. Speak to your health care team about drug and food interactions with this medication.

Note: Some of the side effects above are very rare. If you have concerns and/or questions, please discuss them with your medical team.

How to Take Your Medication

  • Take this drug by mouth without food approximately every 12 hours. Avoid food for at least 2 hours before the dose is taken and avoid food for at least 1 hour after the dose is taken.
  • Swallow the medicine whole with water. Do not chew or crush it.
  • If you have swallowing difficulties, you may open the capsule and sprinkle onto 1 teaspoon of applesauce and swallow immediately (within 15 minutes). Only applesauce should be used. Do not sprinkle your medication on any other food; do not use more than 1 teaspoon of applesauce.
  • Missed dose: If you vomit or miss a dose, take your next dose at the regular time.; Do not take 2 doses at the same time, instead, continue with your regular dosing schedule and contact your physician.
  • Handling: Wash your hands after handling your medicine, your caretakers should not handle your medicine with bare hands and should wear latex gloves.
  • This drug may be present in the saliva, tears, sweat, urine, stool, vomit, semen, and vaginal secretions. Talk to your doctor and/or your nurse about the necessary precautions to take during this time.
  • Storage:Store this medicine in the original container at room temperature. Discuss with your nurse or your doctor how to dispose of unused medicine

Treating Side Effects

  • Manage tiredness by pacing your activities for the day.
  • Be sure to include periods of rest between energy-draining activities.
  • To decrease infection, wash your hands regularly.
  • Avoid close contact with people who have a cold, the flu, or other infections.
  • Take your temperature as your doctor or nurse tells you, and whenever you feel like you may have a fever.
  • To help decrease bleeding, use a soft toothbrush. Check with your nurse before using dental floss.
  • Be very careful when using knives or tools.
  • Use an electric shaver instead of a razor.
  • Keeping your pain under control is important to your well-being. Please tell your doctor or nurse if you are experiencing pain.
  • Ask your doctor or nurse about medicines that are available to help stop or lessen constipation.
  • If you are not able to move your bowels, check with your doctor or nurse before you use enemas, laxatives, or suppositories.
  • Drink plenty of fluids (a minimum of eight glasses per day is recommended).
  • If you throw up or have loose bowel movements, you should drink more fluids so that you do not become dehydrated (lack water in the body from losing too much fluid).
  • If you get diarrhea, eat low-fiber foods that are high in protein and calories and avoid foods that can irritate your digestive tracts or lead to cramping.
  • Ask your nurse or doctor about medicine that can lessen or stop your diarrhea.
  • To help with nausea and vomiting, eat small, frequent meals instead of three large meals a day. Choose foods and drinks that are at room temperature. Ask your nurse or doctor about other helpful tips and medicine that is available to help or stop lessen these symptoms.
  • If you get a rash do not put anything on it unless your doctor or nurse says you may. Keep the area around the rash clean and dry. Ask your doctor for medicine if your rash bothers you.

Food and Drug Interactions

  • Do not eat grapefruit or drink grapefruit juice while taking this medicine. Grapefruit and grapefruit juice may raise the levels of nilotinib in your body. This could make side effects worse.
  • Nilotinib capsules contain lactose, check with your doctor if you have severe problems with galactose intolerance.
  • Check with your doctor or pharmacist about all other prescription medicines and dietary supplements you are taking before starting this medicine as there are known drug interactions with nilotinib. Also, check with your doctor or pharmacist before starting any new prescription or over-the-counter medicines, or dietary supplement to make sure that there are no interactions.
  • Avoid the use of St. John’s Wort while taking nilotinib as this may lower the levels of the drug in your body, which can make it less effective.
  • Drugs that treat heartburn and stomach upset such Maalox®, Mylanta®, Protonix®, Nexium®, Prilosec®, Pepcid®, Tagamet®, and Zantac® may lower the effect of your cancer treatment if taken with nilotinib. Call your doctor to find out what drug you may take with nilotinib to help with heartburn or stomach upset.

When to Call the Doctor

Call your doctor or nurse if you have any of these symptoms and/or any new or unusual symptoms:

  • Fever of 100.5 F (38 C) or higher
  • Chills
  • Fatigue that interferes with your daily activities
  • Feeling dizzy or lightheaded
  • Headache that does not go away
  • Easy bleeding or bruising
  • Feeling that your heart is beating in a fast or not normal way (palpitations)
  • Wheezing or trouble breathing
  • Pain in your chest
  • Cough
  • Coughing up blood
  • Chest pain or symptoms of a heart attack. Most heart attacks involve pain in the center of the chest that lasts more than a few minutes. The pain may go away and come back. It can feel like pressure, squeezing, fullness, or pain. Sometimes pain is felt in one or both arms, the back, neck, jaw, or stomach. If any of these symptoms last 2 minutes, call 911.
  • Symptoms of a stroke such as sudden numbness or weakness of your face, arm, or leg, mostly on one side of your body; sudden confusion, trouble speaking or understanding; sudden trouble seeing in one or both eyes; sudden trouble walking, feeling dizzy, loss of balance or coordination; or sudden, bad headache with no known cause.If you have any of these symptoms for 2 minutes, call 911.
  • Nausea that stops you from eating or drinking and/or is not relieved by prescribed medicines
  • Throwing up more than 3 times a day
  • Loose bowel movements (diarrhea) 4 times a day or loose bowel movements with lack of strength or a feeling of being dizzy
  • No bowel movement in 3 days or when you feel uncomfortable
  • Blood in your urine, vomit (bright red or coffee-ground) and/or stools (bright red, or black/tarry)
  • Signs of tumor lysis: Confusion or agitation, decreased urine, nausea/vomiting, diarrhea, muscle cramping, numbness and/or tingling, seizures.
  • Signs of possible liver problems: dark urine, pale bowel movements, bad stomach pain, feeling very tired and weak, unusual itching, or yellowing of the eyes or skin
  • Your leg or arm is swollen, red, warm and/or painful
  • A new rash or a rash that is not relieved by prescribed medicines
  • If you think you may be pregnant

Reproduction Warnings

  • Pregnancy warning: This drug may have harmful effects on the unborn baby. Women of child bearing potential should use effective methods of birth control during your cancer treatment and for 2 weeks after treatment. Let your doctor know right away if you think you may be pregnant.
  • Breastfeeding warning: Women should not breast feed during treatment and for 2 weeks after treatment because this drug could enter the breast milk and cause harm to a breast feeding baby.
  • Fertility warning: Human fertility studies have not been done with this drug. Talk with your doctor or nurse if you plan to have children. Ask for information on sperm or egg banking.

Revised December 2017

This information is intended to provide helpful health information to the general public and is not to be used in place of any medical, health, psychological, or any other kind of personal professional services. The information herein does not cover all possible uses, actions, precautions, side effects, or interactions of the medicines mentioned, nor is the information intended as medical advice for individual problems or for making an evaluation as to the risks and benefits of taking a particular medication. The dose, method of administration and contraindications for any administered medication should be confirmed before use. UPMC specifically disclaims all responsibility for any liability, loss or risk, personal or otherwise, which is incurred as a consequence, directly or indirectly, of the use and application of any medication mentioned herein.