Latest Cancer TreatmentsDr. Mohammadreza Dabiri
Dr. Mohammadreza Dabiriفارسی
Drug

Nilotinib (Tasigna)

A second-generation tyrosine kinase inhibitor capsule for chronic myeloid leukaemia; taken fasting, twice a day

Updated: 27 October 20262 min read3 references
Generic name
Nilotinib
Brand names
Tasigna
Drug class
Tyrosine kinase inhibitor (BCR-ABL, second generation)
Route
Oral (capsule)
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Key points

  • Nilotinib is taken twice a day on an empty stomach: eat nothing for 2 hours before and 1 hour after each dose [1].
  • In newly diagnosed CML, it controlled the disease faster and more deeply than imatinib [2].
  • It can change the heart rhythm (QT); an ECG is needed before starting, 7 days later and regularly after that [1].

What is this drug and how does it work?

For patients

Nilotinib is a capsule that blocks the faulty protein in chronic myeloid leukaemia cells [1]. It is used from the start, or when imatinib has not worked or caused side effects [1, 3].

For physiciansSpecialist notes
For physicians

A selective BCR-ABL inhibitor designed from the structure of imatinib with tighter binding; active against most resistance mutations except T315I [3].

Which cancers is it used for?

For patients
What is this drug for?
  • Chronic myeloid leukaemia (CML) in chronic phase, from the start or after previous treatment [1]
  • Accelerated-phase CML after imatinib [1]
For physiciansApproved uses and evidence
For physicians
Approved uses and evidence
DiseaseUseKey evidence
Newly diagnosed chronic-phase CMLFirst line [1]ENESTnd: 12-month major molecular response 44% with 300 mg twice daily vs 22% with imatinib [2]
CML resistant or intolerant to imatinib (chronic and accelerated phase)Second line [1]Choice based on ABL1 mutations [3]

How it is taken and dosing

Show detailsHide

Take the capsules twice a day, about 12 hours apart, with water; do not eat for 2 hours before and 1 hour after each dose, because food raises the drug level and increases the risk of heart side effects [1]. Avoid grapefruit.

For physiciansStandard dosing (FDA label), 1 regimen
For physicians

Standard dosing (FDA label)

Nilotinib

CML in adultsCycle length: Daily and continuous

CML in adults

DrugDoseRouteSchedule
Nilotinib300 mg twice daily (newly diagnosed); 400 mg twice daily (resistant or intolerant)Oral, fastingDaily
Cycle length
Daily and continuous
Duration
Until progression or toxicity; with a sustained MR4.5 molecular response after at least 3 years, stopping under monitoring may be considered [1]

ECG at baseline, 7 days after starting, periodically and after any dose change; correct potassium and magnesium before starting. Neutrophils below 1000 or platelets below 50,000: hold and resume at the same dose within 2 weeks, otherwise 400 mg once daily. Lower starting dose in hepatic impairment [1].

Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.

Side effects

For patients

The most common side effects: nausea, skin rash and itching, headache, tiredness, vomiting, diarrhoea, cough, constipation, joint pain, fever and night sweats; and low platelets and blood cells [1].

For physiciansSpecialist notes
For physicians

Common non-haematological adverse reactions (20% or more): nausea, rash, headache, fatigue, pruritus, vomiting, diarrhoea, cough, constipation, arthralgia, nasopharyngitis, pyrexia and night sweats; myelosuppression (thrombocytopenia, neutropenia, anaemia) [1].

Serious side effects

For patients

Serious side effects: heart rhythm changes, narrowing of the arteries to the heart, brain or legs, inflammation of the pancreas, liver damage, blood salt problems, bleeding and fluid build-up in the body [1].

For physiciansBoxed warning
For physicians
  • Boxed warning: QT prolongation and sudden death; contraindicated in hypokalaemia, hypomagnesaemia or long QT syndrome [1].
  • Arterial occlusive events (cardiac, cerebral, peripheral): control cardiovascular risk factors [1].
  • Monitor lipase and amylase, liver enzymes, electrolytes, glucose and lipids [1].

When should I call my doctor?

  • Chest pain, palpitations, fainting or severe dizziness
  • Weakness on one side of the body, or a painful or cold leg
  • Severe abdominal pain
  • Yellowing of the skin or eyes
  • Bleeding or fever

Interactions, pregnancy and precautions

  • Other medicines: do not take antifungal drugs, clarithromycin or medicines that prolong the heart rhythm (such as some antiarrhythmics, methadone or high-dose ondansetron) with it without your doctor's advice; rifampicin and St John's wort reduce its effect [1].
  • Food: always on an empty stomach; do not eat grapefruit [1].
  • Pregnancy: this drug may harm an unborn baby; use effective contraception during treatment and tell your doctor straight away if you become pregnant. Do not breastfeed during treatment [1].
For patients

Frequently asked questions

Why do I have to take it on an empty stomach?

Food raises the level of the drug in the blood and increases the risk of heart rhythm changes [1].

Can I stop the capsules one day?

In some patients with a very deep, lasting response after several years, stopping under close medical supervision may be possible [1, 3]; never stop on your own.

Related cancer types

Leukaemia

Related drugs

Arsenic trioxide (Trisenox)Azacitidine (Vidaza)BendamustineCyclophosphamide (Endoxan)Dasatinib (Sprycel)Doxorubicin (Adriamycin)Filgrastim (Neupogen)Hydroxyurea (Hydrea)

References

3 references
Show all references, 1 with a study cardClose the reference list

Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.

  1. 1
    TASIGNA (NILOTINIB) — Prescribing InformationNovartis Pharmaceuticals Corporation · FDA label · 2026
    Source Back to text: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22
  2. 2
    Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemiaSaglio G, Kim DW, Issaragrisil S, et al · N Engl J Med · 2010;362:2251-9
    DOIPubMed Back to text: 1 2
  3. 3
    European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemiaHochhaus A, Baccarani M, Silver RT, et al · Leukemia · 2020;34:966-984
    Study cardDOIPubMed Back to text: 1 2 3 4

This page is based on reputable scientific sources and was last updated on 27 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.

Printed from the website; the full and up-to-date version: https://drdabiri.com/en/drugs/nilotinib/

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