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Generic Name:

nilotinib, Oral capsule

All Brands

  • Tasigna
SECTION 1 of 5

Highlights for nilotinib

Oral capsule
1

Nilotinib is used to treat chronic forms of myeloid leukemia.

2

This drug is available as a capsule that you take by mouth.

3

Nilotinib is available as the brand-name drug Tasigna. It isn’t available as a generic drug.

IMPORTANT INFORMATION

FDA warning

This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.

Heart rhythm changes and sudden death warning. This drug can slow your heart rhythm (prolong your QT interval). This can lead to death. Having low levels of potassium and magnesium in your body can also increase your risk of slowed heart rhythm from this drug. Do not take this drug if you have low levels of potassium or magnesium or a condition called long QT syndrome.

Your doctor will check these levels before and during your therapy with this drug. Your doctor will also check your heart function before you start taking this drug, after you have been taking it for 7 days, and periodically after that. They’ll also check your heart function after any dosage changes. You should not take drugs that change your heart rhythm while you are taking this drug. Taking this drug with food increases your risk of heart rhythm changes.

Reduced number of blood cells

This drug can decrease your bone marrow’s ability to make blood cells. Your doctor will check your blood cell count every 2 weeks for the first 2 months that you take this drug. After that, your doctor will check your blood cell count every month. You may need to stop taking this drug if your blood cell counts get too low.

Pancreas and liver damage

This drug can cause inflammation of your pancreas and harm your liver. Your doctor will check your liver function before and during your treatment with this drug. If you have symptoms of liver or pancreas damage, your doctor will have you stop taking this drug.

Fluid retention and blood vessel blockage

This drug can cause blockages that decrease the flow of blood through the arteries of your heart, legs, and brain. It can also cause your body to retain fluid. This retained fluid can collect around your heart and lungs, which can cause shortness of breath. Your doctor will check your weight and the function of your lungs, heart, and blood vessels before and during your therapy with this drug. Your doctor will check and manage your risk factors for heart and blood vessel disease while you take this drug.

Tumor lysis syndrome

This drug may lead to tumor lysis syndrome. This condition is caused by the fast breakdown of cancer cells. It can be fatal (cause death). Your doctor may do blood tests to check for signs of tumor lysis syndrome. Symptoms can include nausea, shortness of breath, irregular heart rate, cloudy urine, and tiredness.

What is this drug?

This drug is a prescription drug. It comes in a capsule that you take by mouth. It is available as the brand-name drug Tasigna. It isn’t available as a generic drug.

This drug may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

This drug is used to treat a type of blood cancer called chronic myeloid leukemia. It’s used in adults who’ve been newly diagnosed with this cancer and who can’t tolerate therapy with the drug imatinib. It’s also used in people who have chronic or accelerated phases of this cancer when the cancer is resistant to treatment with imatinib.

How it works

This drug belongs to a class of cancer drugs called tyrosine kinase inhibitors. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

This drug blocks a certain enzyme in your blood. This action helps stop your body from making cancer cells.

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SECTION 2 of 5

nilotinib Side Effects

Oral capsule

More common side effects

The more common side effects of nilotinib can include:

  • nausea

  • rash

  • headache

  • tiredness

  • itching

  • vomiting

  • diarrhea

  • cough

  • constipation

  • bone pain

  • nose and throat inflammation

  • fever

  • night sweats

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects from nilotinib. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Tumor lysis syndrome. Symptoms can include:

    • nausea
    • shortness of breath
    • irregular heart rate
    • cloudy urine
  • Tiredness

  • Changes in heart rhythm. Symptoms can include:

    • loss of consciousness
    • seizures
  • Fluid retention. Symptoms can include:

    • sudden weight gain
    • sudden swelling
    • shortness of breath
  • Blockage in your arteries. Symptoms can include:

    • chest pain
    • leg pain
  • Stroke. Symptoms can include:

    • weakness in one part or side of your body
    • slurred speech
  • Inflammation of your pancreas. Symptoms can include:

    • pain in your abdomen
  • Liver damage. Symptoms can include:

    • yellowing of your skin or the whites of your eyes
    • dark urine
    • nausea
    • pain in your abdomen
  • Abnormal bleeding

Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

This drug may cause tiredness.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
SECTION 3 of 5

nilotinib May Interact with Other Medications

Oral capsule

Nilotinib can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Food interactions

Don’t eat grapefruit or drink grapefruit juice if you’re taking this drug. Grapefruit can make it harder for your body to process this drug. As a result, this drug may not work as well.

Medications that might interact with this drug

Drugs you should not use with nilotinib

Do not take these drugs with nilotinib. When used with nilotinib, these drugs can cause dangerous effects in your body. Examples of these drugs can include:

  • Heart rhythm drugs such as amiodarone, disopyramide, procainamide, quinidine, and sotalol
    • These drugs can also prolong the QT interval. Taking these drugs with nilotinib can further increase your risk for heart rhythm changes.
  • Drugs to treat malaria such as chloroquine
    • When used with nilotinib, these drugs can cause heart rhythm changes.
  • Antibiotics such as clarithromycin and moxifloxacin
    • When used with nilotinib, these drugs can cause heart rhythm changes.
  • Antibiotics such as chloramphenicol
    • When used with nilotinib, these drugs can increase the amount of nilotinib in your body.
  • Antipsychotics such as haloperidol and pimozide
    • When used with nilotinib, these drugs can cause heart rhythm changes.
  • Drugs such as methadonethat treat narcotic addiction
    • When used with nilotinib, these drugs can cause heart rhythm changes.
  • Antiviral drugs such as ritonavir
    • When used with nilotinib, these drugs can increase the amount of nilotinib in your body.
  • Antifungal drugs such as ketoconazole and itraconazole
    • When used with nilotinib, these drugs can increase the amount of nilotinib in your body.
  • Antidepressants such as nefazodone
    • When used with nilotinib, these drugs can increase the amount of nilotinib in your body.
  • Proton pump inhibitors such as omeprazole, rabeprazole, and esomeprazole
    • These drugs stop stomach acid from being produced. This decreases how quickly your body absorbs nilotinib.

Interactions that increase the risk of side effects

Increased side effects from other drugs: Taking nilotinib with certain drugs raises your risk of side effects from those drugs. Examples of these drugs include:

  • Sedatives such as midazolam
    • Increased side effects can include tiredness.
  • Cholesterol drugs such as atorvastatin, fluvastatin, and lovastatin
    • Increased side effects can include muscle aches and muscle twitching.
  • Pain drugs such as alfentanil and fentanyl
    • Increased side effects can include drowsiness.
  • Immune suppression drugs such as cyclosporine, sirolimus, and tacrolimus
    • Increased side effects can include risk of infections.
  • Migraine drugs such as dihydroergotamine and ergotamine
    • Increased side effects can include nausea and diarrhea.

Increased side effects from nilotinib : Taking nilotinib with certain drugs raises your risk of side effects from nilotinib . This is because the amount of nilotinib in your body may be increased. Examples of these drugs include:

  • Antibiotics such as azithromycin
  • Blood pressure drugs such as captopril or verapamil

Drugs that can make nilotinib less effective

When used with nilotinib, these drugs can make nilotinib less effective. This means it won’t work as well to treat your condition. This is because the amount of nilotinib in your body may be decreased. Examples of these drugs include:

  • Drugs for seizures such as phenytoin, carbamazepine, oxcarbazepine, and phenobarbital
  • Antibiotics such as rifampicin
  • Alternative drugs such as St. John’s wort
  • Diabetes drugs such as pioglitazone

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Drug warnings
lactose intolerance warning
People with lactose intolerance

Do not take this drug. The capsules contain lactose.

liver problem warning
People with liver problems

You may need to use a different medicine to treat your cancer. If you must take this drug, you may need to take a lower starting dosage. Every month, your doctor will check your liver to see if you should take a different dosage or stop taking this drug entirely.

heart rhythm warning
People with heart rhythm problems

This drug can cause heart rhythm changes that can cause sudden death. If you have heart problems or are taking drugs that cause heart rhythm changes, this drug may make your condition worse or lead to death. Your doctor may use a different medicine to treat your cancer.

stroke or blockage warning
People with stroke or blockage

This drug can cause a blockage in the arteries of your legs, brain, or heart. This can decrease your blood and oxygen supply (ischemia). If you have a history of heart attack, stroke, or peripheral arterial disease, your doctor will monitor your risk for heart and blood vessel disease while you are taking this drug.

pancreatitis warning
People with pancreatitis

If you have pancreatitis, your doctor will do blood tests at least monthly. If you show signs of pancreas damage, your doctor will stop your treatment with this drug and check you for pancreatitis. Based on your blood test results, your doctor may restart your treatment with this drug at a lower dosage or different schedule.

electrolyte warning
People with abnormal levels of electrolytes

If you have low potassium or low magnesium, you’re at increased risk of heart rhythm changes. Do not use this drug if you have low potassium or magnesium levels. This drug can also cause low levels of phosphate, calcium, and sodium and high or low levels of potassium. This effect can worsen problems you already have. You will need to take supplements to correct your low electrolyte levels before using this drug. Your doctor will check your blood levels of electrolytes before you start this drug and periodically while you take it.

bleeding warning
People with bleeding (hemorrhage)

This drug can cause severe bleeding in your stomach and intestines. This can worsen any bleeding or bleeding ulcers you already have.

total gastrectomy warning
People with total gastrectomy

If you’ve had surgery to remove your stomach, you may not absorb enough of this drug to treat your cancer. Your doctor will check you more frequently. You may need an increased dosage or a different drug to treat your cancer.

heart failure warning
People with congestive heart failure

This drug can cause fluid retention. This can worsen your congestive heart failure. Symptoms of fluid retention can include shortness of breath, sudden increases in weight or swelling, and water around your heart, lungs, or liver. Tell your doctor if you have congestive heart failure before you start this drug.

blood cell count warning
People with low blood cell counts

This drug can decrease the number of your platelets, white blood cells, and red blood cells. This effect can worsen problems you already have. Your doctor will check your blood cell counts before you start this drug and every 2 weeks for the first 2 months that you take this drug. After that, they’ll check every month. If your blood cell levels are low, your doctor will likely have you stop taking this drug. If the number of your blood cells increases in the following 2 weeks, your doctor may have you restart this drug. If your levels are still low after 2 weeks, your doctor may have you restart this drug but at a decreased dosage.

severe heart disorders
People with uncontrolled or severe heart disorders

This drug can cause side effects that can worsen heart problems from a recent heart attack, congestive heart failure, unstable angina (unstable chest pain), or slow heart rate (bradycardia). You should use this drug with caution.

pregnancy warning
Pregnant women

This drug is a category D pregnancy drug. That means two things:

  1. Research in humans has shown adverse effects to the fetus when the mother takes the drug.
  2. This drug should only be used during pregnancy in serious cases where it's needed to treat a dangerous condition in the mother.

Talk to your doctor if you’re pregnant or plan to become pregnant. Ask your doctor to tell you about the specific harm that may be done to the fetus. This drug should be only used if the potential risk to the fetus is acceptable given the drug’s potential benefit.

breast feeding warning
Women who are breast-feeding

This drug may pass into breast milk and cause side effects in a child who is breastfed. Talk to your doctor about breastfeeding your child. You may need to decide whether to stop breastfeeding or stop taking this medication.

childrens warning
For children

This medication has not been studied in children. It should not be used in people younger than 18 years.

when to call the doctor
When to call the doctor

Call your doctor right away if you become pregnant while taking this drug.

allergy warning
Allergies

This drug can cause allergic reactions, but severe allergic reactions have not been reported.

If you have an allergic reaction to this drug, call your doctor or local poison control center right away. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

SECTION 4 of 5

How to Take nilotinib (Dosage)

Oral capsule

All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:

  • your age
  • the condition being treated
  • how severe or resistant your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Chronic myeloid leukemia

Brand: Tasigna

Form: oral capsule
Strengths: 150 mg, 200 mg
Adult dosage (ages 18 years and older)

The typical starting dosage is 300–400 mg twice per day in doses that are 12 hours apart.

Child dosage (ages 0–17 years)

It has not been confirmed that Tasigna is safe and effective for use in people younger than 18 years.

Special considerations

People with liver damage: Your starting dosage is typically 200–300 mg twice per day.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Clinical Associate Professor, University of Illinois at Chicago College of Pharmacy

This drug comes with serious risks if you don’t take it as prescribed.

If you stop taking the drug suddenly or don’t take it at all

Your cancer will likely get worse.

If you miss doses or don’t take the drug on schedule

Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.

If you take too much

You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:

  • vomiting
  • drowsiness

If you think you’ve taken too much of this drug, call your doctor or local poison control center. If your symptoms are severe, call 9-1-1 or go to the nearest emergency room right away.

What to do if you miss a dose

Take the next dose as scheduled. Do not take two doses to make up for the missed dose. This could result in dangerous side effects.

How to tell if the drug is working

You may not notice any difference. Your doctor will run tests to make sure the drug is working for you.

This drug is used for long-term treatment.

Do not take this drug with food

Do not eat 2 hours before taking this drug and for 1 hour after. Taking this drug with food can cause more of the drug to stay in your body. This can increase side effects.

Do not cut or crush the capsule

If you can’t swallow the capsule whole, you may open it and mix the contents into 1 teaspoon of applesauce. Take the mixture within 15 minutes. Do not store it for future use.

Store this drug carefully

  • Store this drug at room temperature between 59°F and 86°F (15°C and 30°C).
  • Don’t store this medication in moist or damp areas, such as bathrooms.

A prescription for this medication is refillable

You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.

Travel

When traveling with your medication:

  • Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
  • Don’t worry about airport x-ray machines. They can’t hurt your medication.
  • You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled box with you.
  • Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.

Clinical monitoring

Your doctor may monitor your health with certain tests during your treatment. This can help make sure you stay safe while you take this drug. These tests include:

  • Heart function tests. Your doctor will do electrocardiography to check your heart function before and during your treatment with this drug.
  • Lipase level tests. This drug may increase your lipase levels. Your doctor will check these levels before and during your treatment with this drug.
  • Liver function tests. Your doctor will do liver function tests before you start taking this drug. They may also do these tests while you are taking this drug.
  • Complete blood count. Your doctor will do a test called a complete blood count (CBC) to check how well your bone marrow is making blood cells. Your doctor will give you this test before you start this drug and while you take it.
  • Cholesterol and blood sugar level tests. Your doctor will test your cholesterol and blood sugar levels before and during your therapy with this drug.
  • Uric acid level tests. This drug can cause a condition called tumor lysis syndrome, which can greatly increase your uric acid levels. Your doctor will check your uric acid levels before and during your treatment with this drug.

Sun sensitivity

This drug can make your skin more sensitive to the sun. This increases your risk of sunburn. Avoid the sun if you can. If you can’t, be sure to apply sunscreen and wear protective clothing.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.

Are there any alternatives?

There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.

SECTION 5 of 5

How Much Does nilotinib Cost?

Oral capsule

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Lowest price for nilotinib

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These prices represent the lowest priced national pharmacies for nilotinib on GoodRx. They may be lower than your insurance.

Show Sources

  • Novartis Pharmaceuticals Corporation. (2015, October). Tasigna (nilotinib) capsules for oral use [package insert]. East Hanover, NJ.

Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on March 25, 2016

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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