Tasigna (Nilotinib)

What it is and what it treats

Nilotinib, marketed as Tasigna, is a second-generation tyrosine kinase inhibitor (TKI) developed by Novartis. It is authorised for adults and, in some regions, children with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase, and for chronic- or accelerated-phase Ph+ CML in patients resistant or intolerant to prior therapy, most often imatinib.

CML arises from the BCR-ABL fusion gene created by the t(9;22) chromosomal translocation, which produces a constitutively active tyrosine kinase driving uncontrolled proliferation of myeloid cells. Nilotinib binds the ATP pocket of BCR-ABL with substantially greater in vitro potency than imatinib and also inhibits KIT and PDGFR kinases, giving it activity against many imatinib-resistant BCR-ABL mutations.

Because deep and durable molecular responses are achievable with nilotinib, some regulators have authorised its use in a treatment-free remission setting: carefully selected patients who sustain a deep molecular response for a defined period may, under close medical supervision, attempt supervised discontinuation. This remains a physician-led decision based on monitoring criteria, not a general treatment goal.

Presentations and dosage forms

• 150 mg hard capsules
• 200 mg hard capsules
• Supplied in blister packaging for oral administration
• Capsules are taken as a fixed number twice daily according to the indication and treatment line

How it is administered

The approved label describes a starting dose of 300 mg twice daily for newly diagnosed chronic-phase Ph+ CML, and 400 mg twice daily for chronic- or accelerated-phase disease resistant or intolerant to prior therapy. The two daily doses are taken approximately 12 hours apart. Dose adjustments for adverse reactions or drug interactions are described in the label and are determined by the treating haematologist.

A defining feature of nilotinib administration is the fasting requirement: the label describes taking each dose on an empty stomach, with no food for at least two hours before and at least one hour after dosing. Food, particularly high-fat meals, markedly increases nilotinib absorption and can raise the risk of QT-interval prolongation, so this timing is not optional guidance but a labelled requirement.

Nilotinib carries a boxed warning for QT-interval prolongation and the risk of sudden cardiac death. The label describes obtaining a baseline ECG and correcting hypokalaemia or hypomagnesaemia before starting, with periodic ECG and electrolyte monitoring during treatment, particularly after dose changes. Concomitant use of other QT-prolonging medicines, strong CYP3A4 inhibitors, and foods such as grapefruit are addressed in the prescribing information because they can further increase exposure and cardiac risk.

Storage and handling

• Store below 30 °C in the original packaging
• Keep the container tightly closed to protect from moisture
• Keep out of the reach of children
• Do not use beyond the expiry date printed on the pack

Side effects

The prescribing information for Tasigna describes an adverse-reaction profile drawn from CML trials, together with several boxed and label-highlighted warnings relating to cardiac and metabolic effects that require monitoring throughout treatment.

Commonly reported

Serious effects requiring medical attention

Patients should seek urgent medical attention for palpitations, fainting or chest pain, and should report suspected adverse reactions through their national pharmacovigilance scheme, such as the MHRA Yellow Card Scheme or FDA MedWatch.

Tasigna compared with imatinib and dasatinib

Imatinib (Gleevec) was the first BCR-ABL tyrosine kinase inhibitor approved for CML and remains a reference first-line option. Nilotinib is substantially more potent against BCR-ABL in vitro and, in head-to-head first-line trials, produced faster and deeper molecular responses than imatinib, though imatinib has a simpler once- or twice-daily dosing pattern without a strict fasting requirement and a comparatively lower cardiac monitoring burden.

Dasatinib (Sprycel) is another second-generation BCR-ABL inhibitor with a broader kinase-inhibition profile and documented central nervous system penetration. Unlike nilotinib, dasatinib can be taken with or without food, which may suit patients for whom the fasting regimen is impractical. Nilotinib, however, has more extensive regulatory-authorised data supporting treatment-free remission after sustained deep molecular response. The choice between the two second-generation agents in practice depends on the patient's comorbidities (particularly cardiovascular and pulmonary history), specific BCR-ABL mutation profile, and tolerance of each drug's distinct monitoring requirements — a decision made by the treating haematologist.

Availability and supply route

Tasigna is registered in numerous markets, but authorised pack sizes, strengths and continuous commercial availability vary by country and can change over time. Haematology units managing CML sometimes need to source authorised stock through channels outside their immediate domestic supply chain, particularly for less commonly stocked strengths.

Where local registration or supply is temporarily unavailable, hospitals and specialist pharmacies may use named-patient (or 'unlicensed medicine') import routes, permitted under most national regulatory frameworks, to obtain an internationally authorised medicine for a specific, identified patient under direct physician responsibility. This mechanism requires a valid prescription and appropriate import documentation, and is distinct from general retail sale.

Pharmacy Remedy is a licensed pharmaceutical wholesaler based in Turkey supplying hospitals, oncology and haematology clinics, and licensed pharmacies against valid prescriptions and institutional documentation. It operates within licensed business-to-business pharmaceutical supply chains and does not sell Tasigna, or any prescription oncology medicine, directly to members of the public.

Frequently asked questions

Primary sources

• EMA — Tasigna EPAR
• FDA — Tasigna prescribing information

Further reading and regulatory routes

• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Xospata (gilteritinib)
• Calquence (acalabrutinib)
• Erivedge (vismodegib)