Pronunciation: Dan-zi-ten
Generic name: nilotinib
Dosage form: oral tablet (71 mg, 95 mg)
Drug class: BCR-ABL tyrosine kinase inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Nov 18, 2024.

What is Danziten?

Danziten is used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults. Danziten is equivalent in effectiveness to Tasigna, but its formulation means patients do not need to take it in a fasting state. 

Danziten’s mechanism of action involves specifically targeting BCR-ABL tyrosine kinase, a protein that activates signaling pathways that promote cancer growth and survival. By blocking this protein, Danziten can stop cancer cell growth and trigger cell death (apoptosis) and is particularly effective against cells with the Philadelphia chromosome. It is usually used when other treatments have not worked or are not tolerated.

Danziten is a targeted cancer treatment, it is not chemotherapy. Danziten belongs to the drug class called kinase inhibitors.

Danziten gained FDA approval on Nov 14, 2024, and is a brand name for nilotinib. Tasigna is a different formulation of nilotinib that needs to be taken on an empty stomach.

Danziten uses

Danziten is FDA-approved for adults with:

• Newly diagnosed PH+ CML in chronic phase
• Chronic phase PH+ CML or accelerated phase PH+ CML who are no longer benefiting from or intolerant of other treatments, including imatinib (Gleevec).

Danziten side effects

The most common side effects of Danziten are:

• nausea
• cough
• rash
• constipation
• headache
• muscle and joint pain
• tiredness
• runny or stuffy nose, sneezing, sore throat
• itching
• fever
• vomiting
• night sweats
• diarrhea.

Danziten may also cause the following common side effects when stopping treatment, in those patients attempting treatment-free remission:

• muscle pain
• arm and leg pain
• joint pain
• bone pain
• spine pain.

Danziten serious side effects and warnings

Danziten carries a Boxed Warning for QT prolongation and sudden deaths.

QT interval prolongation. Danziten can cause a possible life-threatening heart problem called QTc prolongation. QTc prolongation causes an irregular heartbeat, which may lead to sudden death. Your healthcare provider should check the electrical activity of your heart with a test called an electrocardiogram (ECG):

• before starting Danziten
• with any dose changes
• 7 days after starting Danziten
• regularly during treatment

You may lower your chances for QTc prolongation by:

• Not drinking grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract during treatment with Danziten. Grapefruit products increase the amount of Danziten in your body.
• Avoiding taking other medicines or supplements with Danziten that can also cause QTc prolongation, such as antipsychotics, antiarrhythmics, antibiotics, antidepressants, sumatriptan, ondansetron, methadone, and cisapride.
• Not taking any other medicine during treatment with Danziten unless your healthcare provider tells you it is okay to do so.

Call your healthcare provider right away if you feel lightheaded, faint, or have an irregular heartbeat during treatment with Danziten. These can be symptoms of QTc prolongation.

Danziten may cause other serious side effects.

Low blood cell counts. Low blood cell counts (red blood cells, white blood cells, and platelets) are common with Danziten, but can also be severe. Your healthcare provider will check your blood counts regularly during treatment. Call your healthcare provider or get medical help right away if you develop any signs or symptoms of low blood counts, including:

• fever
• unexplained bleeding or bruising
• shortness of breath
• chills or other signs of infection
• unexplained weakness.

Decreased blood flow to the leg, heart, or brain. People who have recently been diagnosed with Ph+ CML and take Danziten may develop decreased blood flow to the leg, the heart, or the brain. Get medical help right away if you suddenly develop any of the following symptoms:

• chest pain or discomfort
• problems walking or speaking
• your leg feels cold
• numbness or weakness
• leg pain
• change in the skin color of your leg.

Pancreas inflammation (pancreatitis). Tell your healthcare provider right away if you develop any symptoms of pancreatitis, including sudden stomach area pain with nausea and vomiting.

Liver problems. Danziten can increase your risk of liver problems. People who have had liver problems in the past may be at risk for getting liver problems with Danziten. Call your healthcare provider or get medical help right away if you develop any symptoms of liver problems, including:

• stomach area (abdominal) pain
• yellow skin and eyes
• dark-colored urine.

Tumor Lysis Syndrome (TLS). TLS is caused by a fast breakdown of cancer cells. Your healthcare provider may do blood tests to check you for TLS. TLS can cause you to have:

• kidney failure and the need for dialysis treatment
• an abnormal heartbeat.

Bleeding problems. Serious bleeding problems and death have happened during treatment with Danziten. Tell your healthcare provider right away if you develop any signs and symptoms of bleeding during treatment.

Fluid retention. Your body may hold too much fluid (fluid retention). Symptoms of fluid retention include shortness of breath, rapid weight gain, and swelling.

Abnormal growth or development in children. Effects on growth and development have happened in children with chronic phase Ph+ CML during treatment with nilotinib. Some children and adolescents may have slower than normal growth during treatment with nilotinib. Danziten is not FDA-approved for use in children.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Danziten. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

Before taking

Do not take Danziten if you have low levels of potassium or magnesium in your blood or long QTc syndrome.

Before taking Danziten, tell your healthcare provider about all of your medical conditions, including if you:

• have heart problems
• have had a stroke or other problems due to decreased blood flow to the brain
• have problems with decreased blood flow to your legs
• have irregular heartbeat
• have QTc prolongation or a family history of it
• have liver problems
• have had pancreatitis
• have low blood levels of potassium or magnesium in your blood
• have bleeding problems
• had a surgical procedure involving the removal of the entire stomach (total gastrectomy)
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

Danziten can harm your unborn baby. Tell your healthcare provider right away if you are pregnant, or if you become pregnant during treatment with Danziten. In females who are able to become pregnant:

• Your healthcare provider should do a pregnancy test before you start treatment with Danziten.
• Use effective birth control (contraception) during treatment with Danziten and for 14 days after the last dose.

Breastfeeding

It is not known if Danziten passes into your breast milk. Do not breastfeed during treatment and for 14 days after your last dose.

How do I take Danziten?

Do not switch from Danziten to other medicines that contain nilotinib without talking to your healthcare provider.

• The amount of nilotinib in a dose of Danziten may not be the same as the amount in other medicines that contain nilotinib.

Take Danziten exactly as your healthcare provider tells you to take it.

• Danziten is taken 2 times a day, about 12 hours apart.
• Danziten may be taken with or without food.
• Swallow Danziten tablets whole with water. Do not cut, crush, or chew the tablets. If you cannot swallow the tablets whole, tell your healthcare provider.

Do not change your dose or stop taking Danziten unless your healthcare provider tells you.

During treatment with Danziten your healthcare provider will do tests to check for side effects and to see how well Danziten is working for you. The tests will check your:

• heart
• blood cells (white blood cells, red blood cells, and platelets). Your blood cells should be checked every 2 weeks for the first 2 months and then monthly.
• electrolytes (potassium, magnesium)
• pancreas and liver function
• bone marrow samples.

Your healthcare provider may change your dose. Your healthcare provider may have you stop Danziten for some time or lower your dose if you have side effects with it.

Your healthcare provider will monitor your CML during treatment with Danziten to see if you are in remission.

Danziten is a long-term treatment. After at least 3 years of treatment with Danziten, your healthcare provider may do certain tests to determine if you continue to be in remission. Based on your test results, your healthcare provider may decide if you may be eligible to try stopping treatment with Danziten. This is called Treatment Free Remission (TFR).

• Your healthcare provider will carefully monitor your CML during and after you stop taking Danziten. Based on your test results, your healthcare provider may need to re-start your Danziten if your CML is no longer in remission.
• It is important that you are followed by your healthcare provider and undergo frequent monitoring to find out if you need to re-start your Danziten treatment because you are no longer in TFR. Follow your healthcare provider’s instructions about re-starting Danziten if you are no longer in TFR.

Danziten dosage

Recommended Adult Dose of Danziten for Newly Diagnosed Ph+ CML-CP: 142 mg orally twice daily.

Recommended Adult Dose of Danziten for Resistant or intolerant Ph+ CML-CP and CML-AP: 190 mg orally twice daily. 

What should I avoid while taking Danziten?

Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract at any time during treatment.

Do not take any other medicine during treatment with Danziten unless your healthcare provider tells you it is okay to do so.

What happens if I miss a dose?

If you miss a dose, just take your next dose at your regular time. Do not take 2 doses at the same time to make up for a missed dose.

What happens if I overdose?

If you take too much Danziten, call your healthcare provider or go to the nearest hospital emergency room right away. Symptoms may include vomiting and drowsiness.

What other drugs will affect Danziten?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take:

• a medicine to block the amount of acid produced in the stomach (H2 blocker): Take these medicines about 10 hours before you take Danziten, or about 2 hours after you take Danziten
• an antacid that contains aluminum hydroxide, magnesium hydroxide, and simethicone to reduce the amount of acid in the stomach: Take these medicines about 2 hours before or about 2 hours after you take Danziten
• a medicine that prolongs the QTc interval, such as antipsychotics, antiarrhythmics, antibiotics, antidepressants, sumatriptan, ondansetron, methadone, and cisapride.

Do not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract during treatment with Danziten. Grapefruit products increase the amount of Danziten in your body.

Nilotinib can interact with many medicines and supplements and increase your chance of serious and life-threatening side effects. This is not a complete list of interactions. See the Danziten Prescribing Information for a complete list.

Danziten storage

Store Danziten at room temperature between 68°F to 77°F (20°C to 25°C).

Safely throw away medicine that is out of date or no longer needed.

Keep out of the reach of children.

Danziten ingredients

Active ingredient: nilotinib tartrate.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, iron oxide red (in 71 mg strength tablets), iron oxide yellow (in 95 mg strength tablets), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Available as Danziten 71 mg and 95 mg oral tablets.

Who makes Danziten?

Azurity Pharmaceuticals, Inc. makes Danziten.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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