Nilotinib (Danziten, Tasigna): Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

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Overview: Nilotinib is used to treat certain cancers. Common side effects include nausea, rashes, and headaches. Call your health care provider right away if you get a fever, rash, swelling, unexplained bleeding, or severe diarrhea. Nilotinib is a tablet or capsule that you will swallow.

Uses

What is nilotinib used for?

Nilotinib is commonly used to treat certain kinds of chronic myeloid leukemia (CML).

Nilotinib may also be used for other conditions as determined by your health care provider.

How does nilotinib work (mechanism of action)?

Nilotinib is a type of medicine known as a tyrosine kinase inhibitor (TKI). It works by targeting specific proteins on cancer cells. By blocking the action of these proteins, nilotinib can cause cancer cells to die and can prevent cancer cells from growing or spreading.

How is nilotinib supplied (dosage forms)?

Brands and other names

Danziten
Tasigna

Dosage forms and strengths

50 mg, 150 mg, and 200 mg oral capsules
71 mg and 95 mg oral tablets

How should I store nilotinib?

Nilotinib should be stored at room temperature, between 68 F and 77 F (20 C and 25 C). It can be exposed to temperatures between 59 F and 86 F (15 C and 30 C) for shorter periods of time, such as when you’re transporting it. Store it in a cool, dry place.

Side Effects

What are the most common side effects of nilotinib?

The most common side effects of nilotinib are listed below. Tell your health care provider if you have any of these side effects that bother you.

Nausea and vomiting
Rash
Headache
Tiredness
Diarrhea
Cough
Constipation
Joint pain
Infection in the nose or throat, sore throat, or common cold symptoms
Fever
Night sweats
Blood disorders (see below)

There may be other side effects of nilotinib that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of nilotinib?

While less common, the most serious side effects of nilotinib are described below, along with what to do if they happen.

Severe Allergic Reactions. Nilotinib may cause allergic reactions, which can be serious. Stop taking Nilotinib and get help right away if you have any of the following symptoms of a serious allergic reaction.

Breathing problems or wheezing
Racing heart
Fever or general ill feeling
Swollen lymph nodes
Swelling of the face, lips, mouth, tongue, or throat
Trouble swallowing or throat tightness
Itching or skin rash
Bumps on the skin called hives that can be red, pink, white, or brown, depending on your skin tone
Nausea or vomiting
Dizziness, feeling lightheaded, or fainting
Stomach cramps
Joint pain

Blood Disorders. Nilotinib can cause blood disorders, such as low red blood cells (anemia), low platelet levels (thrombocytopenia), and low neutrophil levels (neutropenia). Attend all of your appointments with your health care provider to have your blood cell counts checked, and stop taking nilotinib and get help right away if you have any of the following symptoms of blood disorders.

Fever
Shortness of breath
Pale or yellowish skin
Easy bruising or bleeding
Frequent infection
Unusual weakness or tiredness
Dizziness, lightheadedness, or feeling like you are about to pass out
Headache
Fast or abnormal heartbeat

Heart Rhythm Changes. Nilotinib may cause a rare, dangerous heart rhythm problem called QT prolongation and torsade de pointes. Some people have a higher risk of this, including people who are older, have other people in their family who have had these conditions, have low potassium or magnesium levels, or who take medicines that can prolong the QT interval. Tell your health care provider right away if you faint or have changes in your heart rate or rhythm, such as a fast or skipping heartbeat.

Heart Attack and Stroke. Nilotinib can increase your risk of a heart attack or stroke that can lead to death. This risk may be higher in people who already have heart disease. Do not take nilotinib if you have had a recent heart attack without talking to your health care provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

Chest pain or pressure
Fast or abnormal heartbeat
Trouble breathing
Pain in your back, jaw, throat, or arm
Sweating, upset stomach, vomiting, or dizziness
Sudden weakness on one side of your body
Sudden and severe headache
Slurred speech or trouble understanding speech

Inflammation of the Pancreas (Pancreatitis). Nilotinib may cause inflammation of the pancreas, which is called pancreatitis. Stop taking nilotinib and call your health care provider right away if you have symptoms of pancreatitis, including vomiting or severe pain in the upper part of your belly that travels to your back.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking nilotinib. Call your health care provider right away if you have any of the following symptoms of liver damage.

Nausea or vomiting
Stomach or belly pain
Fever
Weakness or unusual tiredness
Itching
Loss of appetite
Light-colored poop
Dark-colored urine (pee)
Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Electrolyte Changes. Nilotinib may cause changes to the levels of certain minerals in your body, called electrolytes. For example, it may cause low potassium levels (hypokalemia), low sodium levels (hyponatremia), low calcium levels (hypocalcemia) or low phosphate levels (hypophosphatemia). These changes can be serious. Keep appointments for bloodwork so that your health care provider can check your electrolyte levels, especially if you take certain other medicines. Call your health care provider if you have any of the following symptoms of electrolyte changes.

Weakness
Unusual tiredness
Muscle cramps or twitching
Constipation
Nausea, vomiting, or loss of appetite
Dizziness
Restlessness or crankiness
A hard time breathing
Confusion or decreased alertness
Changes in your heart rate or rhythm, such as a fast or skipping heartbeat
Fainting
Numbness, tingling, or a burning sensation in your arms, feet, or face (paresthesia)
Muscle pain or spasms
Seizures

Tumor Lysis Syndrome. Nilotinib can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while receiving nilotinib and to keep all appointments for bloodwork so your health care provider can see how your body is responding to nilotinib. Tell your health care provider right away if you have any of the following signs of tumor lysis syndrome while taking nilotinib.

Nausea and vomiting
Weakness
Swelling or fluid retention
Shortness of breath
Muscle cramps
Seizures

Severe Bleeding. Nilotinib can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your health care provider right away if you have any of the following signs of severe bleeding while taking nilotinib.

Pink, red, or brown urine (pee)
Vomit with blood that looks like coffee grounds
Red or black stools (look like tar)
Coughing up blood or blood clots

Fluid Retention (Edema). Nilotinib can cause fluid retention, also called edema. Fluid retention can cause serious issues in people with certain conditions, such as heart failure or kidney problems. Call your health care provider right away if you have any of the following symptoms.

Chest pain
Irregular heartbeat
Shortness of breath
Stretched or shiny skin
Swollen body parts, such as the belly or ankles

Warnings & Precautions

Who should not use nilotinib?

Allergies to Ingredients. People who are allergic to any of the following should not take nilotinib.

Danziten
Tasigna
Nilotinib
Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in the specific nilotinib products they stock.

Low Levels of Magnesium. If you have low magnesium levels (hypomagnesemia), you should not take nilotinib.

Low Levels of Potassium. If you have low potassium levels (hypokalemia), you should not take nilotinib.

Heart Rhythm Problems. If you have certain heart rhythm problems known as long QT syndrome or QT prolongation, you should not take nilotinib.

Talk with your health care provider about any electrolyte or heart problems you have so they can make sure nilotinib is safe for you.

What should I know about nilotinib before using it?

Do not take nilotinib unless it has been prescribed to you by a health care provider. Take it as prescribed.

Do not share nilotinib with other people, even if they have the same condition as you. It may harm them.

Keep nilotinib out of the reach of children.

Nilotinib Capsules. Do not crush or chew nilotinib. If you can’t swallow the capsules, you may open the capsule and sprinkle the contents of each capsule in 1 teaspoon of applesauce. Swallow the mixture right away (within 15 minutes). Take nilotinib at least two hours after eating any food. You should also wait to eat at least one hour after you take your nilotinib dose.

Nilotinib Tablets. Do not crush, chew, or cut nilotinib. You can take the nilotinib tablets with or without food. If you cannot swallow the tablets whole, talk with your pharmacist or health care provider.

What should I tell my health care provider before using nilotinib?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if nilotinib is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. Tell your health care provider if you have any of the following.

Anyone in your family having any heart problems or QT prolongation
Blood clot problems, including a stroke or any other issues with decreased blood flow to the brain
Problems with blood flow to your legs
Liver problems
Prior pancreatitis
Problems eating or digesting lactose or other sugars
Bleeding problems
Prior surgery to remove any part of your stomach

Other Medicines and Supplements. Nilotinib may interact with other medicines and supplements. Before taking nilotinib, tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Pregnancy. Nilotinib may harm an unborn baby. Your health care provider will give you a test to make sure you are not pregnant before you start taking nilotinib. People who can become pregnant should use birth control while taking nilotinib and for 14 days after your last dose. Tell your health care provider if you are pregnant or plan to become pregnant.

Breastfeeding. It is not known if nilotinib passes into breast milk. You should not breastfeed while taking nilotinib and for 14 days after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

Interactions

Does nilotinib interact with foods or drinks?

Nilotinib capsules should be taken at least two hours after eating any food and at least one hour before eating any food.

Grapefruit interacts with nilotinib. It is important to avoid eating grapefruit or drinking grapefruit juice while taking nilotinib. This is because grapefruit can interfere with your body’s ability to break down nilotinib, which can lead to high levels of the medicine and an increased risk of side effects.

It is unknown if drinking alcohol will affect nilotinib, but heavy drinking can slow your immune response and make it harder for your body to fight cancer. Both nilotinib and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does nilotinib interact with other medicines (drug interactions)?

Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking nilotinib.

St. John’s wort, which is a supplement that may be used to treat depression
A proton pump inhibitor (PPI), such as esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex)
An H2 blocker, such as cimetidine (Tagamet), famotidine (Pepcid), or nizatidine (Axid)
An antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone
Medicines that can cause QT prolongation, which is a potentially dangerous heart rhythm problem
Ketoconazole, which is a medicine used for fungal infections
Rifampin (Rifadin) or rifapentine (Priftin), which are medicines commonly used to treat an infection called tuberculosis

Many other medicines may alter the blood levels of nilotinib and vice versa. Tell your health care provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with nilotinib. Always check with your health care provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker