Why is this medication prescribed?
Nilotinib is used to treat certain types of chronic myeloid leukemia (CML; a type of cancer of the white blood cells). Nilotinib is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein in cancer cells. This helps to stop or slow the spread of cancer cells.
How should this medicine be used?
Nilotinib comes as a capsule and a tablet to take by mouth. Take twice a day. Take capsules on an empty stomach, at least 2 hours before or 1 hour after eating any food. Take nilotinib at around the same times every day. Try to space your doses about 12 hours apart.
Take nilotinib exactly as directed. Ask your doctor or pharmacist to explain any part you do not understand. Do not take more or less of it or take it more often than prescribed by your doctor.
Swallow the capsules and tablets whole with a glass of water; do not split, chew, or crush them. If you are not able to swallow the capsules whole, mix the contents of a capsule in one teaspoon of applesauce. Swallow the mixture immediately (within 15 minutes.) Do not store the mixture for future use. Tell your doctor if you are not able to swallow the tablets whole.
Your doctor may decrease your nilotinib dose or stop your treatment depending on how well the medication works for you and if you experience any side effects. Continue to take nilotinib even if you feel well. Do not stop taking nilotinib without talking to your doctor.
Nilotinib tablets are used in different dosages than the capsules. Do not switch from one to the other without talking to your doctor.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking nilotinib,
- tell your doctor and pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
- if you are taking antacids containing magnesium, aluminum (Maalox®, Mylanta®, Tums®, others), or simethicone, take the antacid 2 hours before or at least 2 hours after you take nilotinib.
- if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine, famotidine, nizatidine (Axid®), or ranitidine, take it at least 10 hours before or at least 2 hours after you take nilotinib.
- the following nonprescription or herbal products may interact with nilotinib: St. John's wort and proton-pump inhibitors such as esomeprazole (Nexium®), lansoprazole (Prevacid®), and omeprazole (Prilosec®). Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking nilotinib. Do not start any of these medications while taking nilotinib without discussing with your healthcare provider.
- tell your doctor if you have had a stroke or surgery to remove the entire stomach (total gastrectomy). Also, tell your doctor if you have or have ever had decreased blood flow to your legs, any heart problems, bleeding problems, liver problems, pancreatitis (swelling of the pancreas, a gland behind the that produces substances to help with digestion), or any condition that makes it difficult for you to digest lactose (milk sugar) or other sugars.
- tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are taking nilotinib. You may have to take a pregnancy test before starting treatment. You should use effective birth control to prevent pregnancy while you are taking nilotinib and for 14 days after your final dose. Talk to your doctor about birth control methods that you can use during your treatment. If you become pregnant while taking nilotinib, call your doctor immediately. Nilotinib may harm the fetus.
- tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while you are taking nilotinib and for 14 days after your final dose.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking nilotinib.
What special dietary instructions should I follow?
Do not eat grapefruit, drink grapefruit juice, or take any supplement containing grapefruit extract while taking this medication.
What should I do if I forget a dose?
Skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What side effects can this medication cause?
Nilotinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- rash
- itching
- nausea
- vomiting
- diarrhea
- constipation
- heartburn
- gas
- loss of appetite
- headache
- dizziness
- tiredness
- difficulty falling asleep or staying asleep
- night sweats
- muscle cramps
- back, bone, joint, limb, or muscle pain
- hair loss
- dry or reddened skin
- numbness, burning, or tingling in the hands or feet
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:
- unusual bleeding or bruising, blood in urine, bloody or black, tarry stools
- sudden headache, confusion, or changes in vision
- unusual tiredness or weakness
- pale skin
- chest pain or discomfort, problems walking or speaking, numbness, change in leg skin color, or pain or cold sensation in legs
- stomach pain with nausea and vomiting
- fever, chills, sore throat, ongoing cough and congestion, or other signs of infection
- swelling of hands, ankles, feet, or face; sudden weight gain; or shortness of breath
- pain or discomfort in the right upper stomach area, yellowing of the skin and eyes, or dark urine
- urinating less often than usual
Nilotinib may cause children to grow more slowly. Your child's doctor will watch your child's growth carefully while your child is taking nilotinib. Talk to your child's doctor about the risks of giving this medication to your child.
Nilotinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What should I know about storage and disposal of this medication?
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).
Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reachhttps://www.upandaway.org
Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include:
- fever, sore throat, chills, or other signs of infection
- vomiting
- drowsiness
What other information should I know?
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.
Brand names
- Danziten®
- Tasigna®