Nilotinib (Tasigna, Danziten, Cavhanza, Nilceya)

Nilotinib at a glance

Nilotinib is a tyrosine kinase inhibitor, or TKI. It blocks a protein called BCR-ABL1 that drives abnormal blood-cell growth. Treatment is usually taken twice daily, about 12 hours apart, but the dose and food instructions depend on the formulation.

Verified product names include Tasigna and Nilceya capsules, Danziten tablets and Cavhanza orally disintegrating tablets. Danziten and Cavhanza have different strengths and prescribed doses from Tasigna. They must not be substituted milligram for milligram. Check the name, strength and instructions whenever a new supply arrives.

US labels carry a boxed warning about QT prolongation, an electrical heart-rhythm change that can cause dangerous arrhythmias and sudden death. Blood-vessel disease, low blood counts, pancreatic or liver problems and fluid retention also need attention. Regular tests help detect problems before symptoms become obvious.

What nilotinib is and how it works

In chronic myeloid leukaemia, or CML, a change in chromosomes can join the BCR and ABL1 genes. The resulting BCR-ABL1 protein sends persistent growth signals. The chromosome carrying this change is often called the Philadelphia chromosome. Tests identify the change and help the specialist decide whether this type of treatment is appropriate.

Nilotinib attaches to the abnormal protein and reduces its activity. It is targeted treatment rather than checkpoint immunotherapy. Targeting a particular protein does not mean the medicine affects only leukaemia cells; healthy tissues can also be affected, which explains the monitoring and side effects.

A molecular blood test measures the amount of BCR-ABL1 signal remaining. A falling result can show that treatment is controlling the disease, even if you feel much the same. A very low result is not a reason to stop on your own. Some patients can eventually attempt a carefully monitored period without treatment, but this requires specific criteria and continuing tests.

How the team decides whether it is suitable

Your haematologist considers the diagnosis, disease phase, BCR-ABL1 results, previous treatment, possible resistance mutations and your general health. Nilotinib does not overcome every form of resistance. The team also considers whether you can reliably follow the particular product's schedule and attend monitoring.

Tell the team about heart-rhythm problems, fainting, a family history of long QT syndrome, heart attack, stroke, poor circulation in your legs, diabetes, high cholesterol, smoking, liver disease or pancreatitis. These can influence the balance of benefit and risk. Report any operation that removed your whole stomach because nilotinib exposure can be reduced after total gastrectomy.

US labels say not to use nilotinib in people with long QT syndrome or uncorrected low potassium or magnesium. European Tasigna information describes particular caution and close monitoring for QT risk. Liver-dose advice also differs: US labels specify reduced starting doses, while European Tasigna guidance uses caution without routine adjustment. Your specialist follows the applicable product information.

Children need a paediatric specialist and a product-specific prescription. Tasigna has paediatric dosing based on body surface area; the reviewed newer US product labels do not provide the same paediatric treatment instructions. Adult tablet doses must not be converted into a child's dose at home.

Before treatment starts

An ECG records the electrical activity of the heart. Blood tests check potassium, magnesium and other salts, blood counts, liver function, pancreatic enzymes, glucose and cholesterol. Low potassium or magnesium must be corrected before starting. The team also checks cardiovascular risk factors and agrees how existing diabetes, blood pressure or lipid problems will be managed.

European guidance recommends hepatitis B testing before nilotinib. A previous infection can reactivate. Positive tests require specialist advice, and carriers need monitoring during treatment and for several months afterwards. Antiviral prevention is decided individually; do not assume everyone needs it or stop an existing antiviral medicine.

Bring all prescription medicines, inhalers, shop-bought remedies, vitamins and herbal products for review. Include antacids, acid-suppressing medicines, anti-sickness drugs and cholesterol treatment. Several can change nilotinib levels or add to heart-rhythm risk.

Discuss pregnancy, contraception and fertility plans. US labels recommend a pregnancy test before treatment for patients who could become pregnant. Obtain the hospital's urgent contact details and a clear plan for obtaining repeat supplies. Ask the pharmacist to write a daily schedule that fits your product and meals.

How treatment is taken

Identify the formulation before planning meals

Tasigna and Nilceya capsules are taken on an empty stomach: have no food for at least two hours before each dose and at least one hour afterwards. For example, an 8 am dose means no food after 6 am until 9 am. Water can be used to swallow the dose. Food can increase exposure and make serious side effects more likely.

Danziten tablets and Cavhanza orally disintegrating tablets may be taken with or without food. Their different formulation permits different instructions; this does not remove nilotinib's heart-rhythm warning. Never apply their food instructions to Tasigna or Nilceya.

Examples of adult prescribed doses are 300 mg or 400 mg twice daily for the reviewed capsules, 142 mg or 190 mg twice daily for Danziten, and 120 mg or 160 mg twice daily for Cavhanza. The appropriate dose depends on the clinical situation. Lower doses or once-daily schedules may be prescribed for toxicity, interactions or other circumstances. These examples are not a switching calculator.

Swallowing and preparation

Swallow Tasigna capsules whole with water. If swallowing is difficult, its label allows each capsule's contents to be mixed with one teaspoon of applesauce. Use only applesauce, no more than one teaspoon per capsule, and take immediately; US instructions specify within 15 minutes. Do not save a mixture. This small, approved preparation does not permit a meal with the dose.

Nilceya capsules must be swallowed whole and must not be opened. Danziten tablets must be swallowed whole with water; do not cut, crush or chew them. Do not transfer Tasigna's applesauce method to either product.

For Cavhanza, use dry hands. Place the tablet on the tongue, let it disintegrate and swallow with saliva; liquid is not necessary. Its label also permits chewing before swallowing with saliva, or swallowing intact with water. Do not crush it before taking it. No home feeding-tube method should be improvised from these instructions.

A missed dose, vomiting or an extra dose

If you miss a dose, skip it and take your next scheduled dose at the usual time. Do not take two doses together to make up for a missed dose.

If you vomit after Tasigna, Macmillan advises no replacement dose; continue at the next usual time. For another formulation, do not take an extra dose on your own: contact the team for its vomiting instructions. Repeated vomiting, poor fluid intake or reduced urine needs prompt advice because dehydration can disturb salts and increase rhythm risk. An accidental overdose needs immediate medical advice.

Storage and handling

Keep medicine in its original packaging, away from children and moisture. US products generally specify 20–25°C (68–77°F), allowing brief excursions to 15–30°C (59–86°F); European Tasigna specifies not above 30°C (86°F). Check your own pack. Cavhanza must stay in its original bottle with the cap securely replaced and desiccants retained; never swallow a desiccant.

Ask before repacking doses into an organiser. Return unwanted medicine through your pharmacy or hospital. Tasigna contains lactose, so tell the pharmacist about diagnosed hereditary sugar-intolerance disorders. Do not assume every nilotinib formulation has identical inactive ingredients.

Monitoring and checking whether treatment is working

Blood counts are generally checked every two weeks for the first two months, then monthly, with additional tests as needed. They measure red cells, infection-fighting white cells and platelets, which help stop bleeding. A temporary pause or lower dose may allow counts to recover.

US labels specify ECGs before treatment, seven days after starting, periodically and after dose adjustments. European Tasigna recommends a baseline ECG and further checks as clinically indicated. Potassium and magnesium are checked repeatedly, particularly if vomiting, diarrhoea or another medicine could change them.

Liver tests and lipase, a pancreatic enzyme, are usually checked monthly or when clinically needed. Glucose and cholesterol require baseline and ongoing assessment. European Tasigna specifies lipid checks at months three and six and at least annually afterwards; US labels describe periodic checks in the first year and at least yearly during continuing treatment.

BCR-ABL1 testing follows the depth and stability of response. The laboratory reports results on an International Scale so that changes can be interpreted consistently. Your team explains its testing timetable and what would prompt a repeat test, adherence review, mutation test or treatment change. Children also need monitoring of growth and development because slower growth has been reported.

Common side effects and practical management

Rash, itching and hair changes

Dry skin, rash and itching can occur. Use gentle washing products and a recommended moisturiser, and report a persistent or troublesome rash. Do not start steroid creams, antibiotics or supplements without checking. Hair thinning or hair loss is possible, although the pattern varies; the team can advise about scalp care and support.

A rapidly worsening rash with blisters, skin peeling, mouth sores, facial swelling or breathing difficulty needs urgent assessment. It should not be treated at home as an ordinary itch.

Nausea, bowel changes and mouth symptoms

Prescribed anti-sickness treatment may help, but it must be checked for QT interactions. With fasting capsules, plan smaller meals outside the restricted periods rather than taking the dose with food to settle nausea. Report vomiting that interferes with doses or hydration.

Tell the team about diarrhoea and use its agreed treatment plan. Drink within any prescribed fluid limit. Persistent diarrhoea, fever, blood in the stool, dizziness or reduced urine requires prompt advice. Constipation may improve with appropriate fluids, fibre and gentle activity, with a prescribed laxative when needed.

Gentle mouth care can reduce discomfort from soreness or ulcers. Ask for suitable mouthwash and pain relief if eating or drinking is difficult. Do not ignore severe or persistent abdominal pain, which needs assessment for problems such as pancreatitis.

Fatigue, headache and muscle or joint pain

Fatigue may reflect the illness, anaemia, disturbed sleep or treatment. Balance rest with manageable activity and ask for help with demanding tasks. A sudden deterioration, especially with fever, breathlessness or palpitations, needs assessment rather than simply more rest.

Headache, muscle aches, cramps and joint pain can occur. Discuss pain relief before adding medicines such as anti-inflammatory drugs, especially if platelets are low or you take a blood thinner. Cramps can also accompany electrolyte changes. Report pain that affects walking or daily activity.

Dizziness or visual changes can affect driving and work. Avoid driving or machinery while affected. Sudden weakness, trouble speaking, collapse or a severe new headache is different from routine fatigue and needs emergency care.

Important risks and serious side effects

Heart-rhythm changes

QT prolongation means the heart takes longer to reset electrically between beats. It can trigger a dangerous rhythm. Sometimes there are no early symptoms, which is why ECGs and blood tests matter. Food with fasting capsules, certain interacting medicines and low potassium or magnesium can increase the risk.

Seek emergency help for fainting, collapse, a seizure or a fast or irregular heartbeat with chest pain, breathlessness or severe dizziness. New persistent palpitations also need urgent advice, even without collapse. Do not take potassium or magnesium supplements without a blood-test-based plan.

Reduced blood flow to the heart, brain or limbs

Nilotinib can be associated with narrowing or blockage of arteries. Report new pain in the legs when walking, cold feet, colour changes or wounds that are slow to heal. A suddenly cold, pale, painful or numb limb is an emergency. Chest pressure, sudden breathlessness, facial drooping, one-sided weakness or speech difficulty also require emergency care.

Managing smoking, blood pressure, diabetes and cholesterol is part of treatment safety. Do not start aspirin yourself: its potential benefit must be weighed against bleeding risk and other medicines.

Low blood counts, infection and bleeding

Low neutrophils can make infection more dangerous. Contact the hospital urgently for fever, chills, a new cough, painful urination or feeling suddenly unwell, even if your temperature is normal. Severe breathlessness, confusion or collapse requires emergency care.

Low platelets can cause bruising, bleeding gums or nosebleeds. Report these promptly. Black stools, vomiting blood, bleeding that will not stop or a severe headache after a head injury needs emergency assessment. Anaemia can cause tiredness, pallor, breathlessness and a racing heartbeat; the team decides whether supportive treatment is needed.

Pancreatic, liver and metabolic problems

Pancreatitis is inflammation of the pancreas. Severe or persistent upper abdominal pain, sometimes spreading to the back and accompanied by vomiting, needs urgent assessment. The team may hold treatment while checking the cause. An elevated lipase result alone does not prove pancreatitis, but it must be reviewed.

Yellow eyes or skin, dark urine, loss of appetite or pain beneath the right ribs can indicate liver trouble. Hepatitis B reactivation is another possible cause. Report symptoms promptly and keep monitoring appointments even when you feel well.

Blood glucose may rise. Report marked thirst, frequent urination or unexplained weight loss, particularly if you have diabetes. Confusion, severe dehydration or repeated vomiting with high glucose needs urgent assessment. Cholesterol changes usually cause no symptoms and are managed through tests and an appropriate prescription.

Fluid retention and tumour lysis syndrome

Rapid weight gain, swelling or worsening breathlessness can mean fluid accumulation, including around the lungs or heart. Contact the team promptly; severe breathing difficulty needs emergency care. Do not start water tablets or severely restrict fluids yourself.

Tumour lysis syndrome happens when many leukaemia cells break down and release substances that disturb blood chemistry. It can damage kidneys or affect heart rhythm. The team assesses risk, corrects dehydration and high uric acid, and may prescribe preventive treatment. Reduced urine, marked weakness, cramps, confusion or palpitations needs urgent assessment.

Other medicines, supplements and vaccinations

Nilotinib interacts with medicines that affect CYP3A, an enzyme involved in drug breakdown. Examples requiring review include certain antifungals and antibiotics, ritonavir-containing treatment, rifampicin, carbamazepine, phenytoin and St John's wort. Strong inhibitors or inducers are generally avoided; any necessary adjustment is product-specific and must be prescribed.

Avoid grapefruit, grapefruit juice and grapefruit-containing supplements with all the reviewed products. Some anti-sickness medicines, antibiotics, psychiatric medicines and heart-rhythm drugs can add to QT risk. Tell every prescriber that you take nilotinib before starting a new treatment.

Medicines for reflux and indigestion

US Tasigna, Nilceya and Danziten guidance advises avoiding proton pump inhibitors such as omeprazole. If an H2 blocker is used, take it about ten hours before or two hours after nilotinib. Short-acting antacids are taken about two hours before or after nilotinib. These are different schedules, so obtain a written plan.

European Tasigna information allows proton pump inhibitors when needed, while retaining the H2-blocker and antacid spacing advice. The July 2026 FDA Cavhanza label allows proton pump inhibitors, H2 blockers and antacids together with Cavhanza without those spacing restrictions. Do not transfer this newer formulation's instructions to another product or stop essential reflux treatment yourself.

Cholesterol medicines, blood thinners and other drugs may also need adjustment or monitoring. Arrange vaccination with the treating team: suitability and timing, especially for live vaccines, depend on immune function and the whole treatment plan.

Everyday life during treatment

A consistent routine can make twice-daily treatment easier. For fasting capsules, plan meals and snacks around both doses, including weekends and travel. Ask a dietitian for help if restrictions, nausea or weight change make eating difficult. Danziten and Cavhanza have no fasting requirement, but a switch still needs a new prescription and instructions.

Stay active within your ability and report new exercise-related leg pain or chest symptoms. Ask for smoking-cessation support when relevant. Tell your dentist about treatment and blood counts before procedures. Discuss flexible working, fatigue and transport if symptoms affect safety.

Carry sufficient medicine, its original packaging and contact details when travelling. Ask how to adjust a twice-daily schedule across time zones. Talk about emotional strain, sexual concerns or worries about long-term treatment; support is part of care, not a reason to struggle alone.

Fertility, contraception, pregnancy and breastfeeding

Nilotinib can harm a developing baby. Patients who could become pregnant should use effective contraception during treatment and for 14 days after the last dose; European Tasigna specifies highly effective contraception for the corresponding two-week period. Discuss the method before starting and report suspected pregnancy immediately.

Do not breastfeed during treatment or for two weeks after the final dose. Longer precautions may apply to another medicine. The reviewed nilotinib labels do not specify a fixed male contraception interval; discuss family plans rather than assuming the female interval automatically applies to everyone.

Human effects on fertility have not been adequately studied. Discuss preservation options if future parenthood matters to you. Pregnancy planning during treatment-free remission still needs specialist coordination because molecular relapse may require treatment to restart. Do not stop nilotinib simply to try to conceive without a disease-monitoring plan.

After a pause or the end of treatment

Most patients continue treatment while it is beneficial and tolerable. Selected adults may attempt treatment-free remission, or TFR, after a sustained deep molecular response. Product-label criteria include at least three years of nilotinib treatment, suitable measurable BCR-ABL1 transcripts, a sustained response over the preceding year and other clinical requirements. One undetectable result is insufficient.

Eligibility details depend on previous treatment and the applicable label. The specialist checks the complete response history and access to reliable rapid testing. TFR means stopping under surveillance, not declaring that future testing is unnecessary.

The reviewed labels specify BCR-ABL1 tests and blood counts monthly for the first year after stopping, every six weeks in the second year, then every 12 weeks. Rising results may require more frequent testing. Label-defined loss of response requires restarting within four weeks, with thresholds depending on earlier treatment history. Do not wait for symptoms: molecular relapse can be detected before you feel unwell.

Muscle, joint or bone pain may increase after stopping. Report it for assessment rather than restarting tablets yourself. If treatment is held for toxicity, use the team's written restart plan. Continue agreed heart-risk management, hepatitis monitoring and reproductive precautions after the last dose.

Frequently asked questions