nilotinib
Tasigna · ATC code L01EA03
Brand names: Tasigna, Nilotinib Stada, Nilotinib Teva, Nilotinib Viatris, Nilotinib Zentiva, Nilotinib Al, Nilotinib Bioars, Nilotinib Heumann, Nilotinib Ratiopharm, Niltrion, Nitinab
- Key facts
- Active substance
- nilotinib
- ATC code
- L01EA03
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Tasigna 50 mg hard capsules / Tasigna 150 mg hard capsules / Tasigna 200 mg hard capsules
- Marketing authorisation holder
- Novartis Europharm Limited
- Information as of
- 2026-10-28
Key facts
Nilotinib (Tasigna) is a BCR-ABL tyrosine kinase inhibitor in capsule form used to treat Philadelphia chromosome positive chronic myelogenous leukaemia (CML).
What it is used for
- Newly diagnosed Philadelphia chromosome positive CML in the chronic phase in adults and children.
- Chronic or accelerated phase CML in adults with resistance or intolerance to prior therapy including imatinib.
- Chronic phase CML in children with resistance or intolerance to prior therapy including imatinib.
Dosing
- Adults, newly diagnosed chronic phase CML: 300 mg twice daily.
- Adults with resistance or intolerance (chronic or accelerated phase): 400 mg twice daily.
- Children: 230 mg/m2 twice daily, rounded to the nearest 50 mg (maximum single dose 400 mg).
- Not with food: take 2 hours after a meal and eat nothing for at least one hour after the dose; for swallowing difficulties the capsule contents may be dispersed in one teaspoon of apple sauce.
- A missed dose should not be made up; treatment continues as long as there is clinical benefit.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Myelosuppression (thrombocytopenia, neutropenia, anaemia): blood counts every two weeks for the first 2 months, then monthly.
- QT prolongation; caution in cardiac disease, and sudden deaths have rarely been reported.
- Cardiovascular events such as peripheral arterial occlusive disease, ischaemic heart disease and ischaemic cerebrovascular events; risk factors should be monitored and managed.
- Hepatitis B reactivation in carriers; test for HBV before starting.
- Fluid retention: rapid weight gain should be investigated; avoid grapefruit juice and strong CYP3A4 inhibitors.
Side effects
- Most common (≥15%): rash (26.4%), upper respiratory tract infection (24.8%), headache (21.9%), hyperbilirubinaemia (18.6%), nausea (16.8%), pruritus (16.7%), thrombocytopenia (16.4%), arthralgia (15.8%) and fatigue (15.4%).
- Rare: hepatitis B reactivation.
Interactions
- Avoid strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, clarithromycin, ritonavir); ketoconazole increased nilotinib exposure 3-fold.
- Strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, St John's wort) are likely to reduce exposure relevantly.
- Food increases bioavailability.
Pregnancy and breastfeeding
- Should not be used in pregnancy unless the woman's condition requires it; highly effective contraception until two weeks after ending treatment.
- Do not breast-feed during treatment and for 2 weeks after the last dose.
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Nilotinib Accord · genericAccord Healthcare S.L.U. · EMEA/H/C/006315
- TasignaNovartis Europharm Limited · EMEA/H/C/000798
Source: European Medicines Agency (EMA), product information
Austria
- Nilotinib StadaStada Arzneimittel Gmbh · 1 register entry
- Nilotinib TevaRatiopharm Arzneimittel Vertriebs-Gmbh · 1 register entry
- Nilotinib ViatrisViatris Limited · 1 register entry
- Nilotinib ZentivaZentiva, K.S. · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- Nilotinib AlAliud Pharma Gmbh · 3 register entries
- Nilotinib BioarsBioars Therapeutics S.A. · 1 register entry
- Nilotinib HeumannTorrent Pharma (Malta) Ltd · 1 register entry
- Nilotinib RatiopharmRatiopharm Gmbh · 1 register entry
- Nilotinib StadaStadapharm Gmbh · 1 register entry
- Nilotinib ViatrisViatris Germany Gmbh · 1 register entry
- Nilotinib ZentivaZentiva Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Turkey
- NiltrionDEVA HOLDİNG A.Ş. · 4 register entries
- NitinabNOBEL İLAÇ SAN. VE TİC. A.Ş. · 4 register entries
- TasignaNOVARTİS SAĞLIK GIDA VE TARIM ÜRÜNLERİ SAN. VE TİC. A.Ş. · 4 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 28 more European countries
- Belgium
- Nilotinb Eg, Nilotinib
- Bulgaria
- Нилотиниб Зентива, Нилотиниб Стада, Нилотиниб Тева, Нилотиниб Фармасайънс, Нитинаб
- Croatia
- Nilmat, Nilotinib Devatis, Nilotinib Olpha, Nilotinib Pgf, Nilotinib Pharmascience, Nilotinib Stada, Nilotinib Teva, Nilotinib Zentiva
- Cyprus
- Nilotinib Bioars, Nilotinib Olpha, Nilotinib Stada
- Czechia
- Nilotinib
- Denmark
- Nilotinib "olpha", Nilotinib Stada, Nilotinib Teva, Nilotinib Viatris, Nilotinib Zentiva
- Estonia
- Nilotinib Olpha, Nilotinib Stada, Nilotinib Teva, Nilotinib Viatris, Nilotinib Zentiva
- Finland
- Nilotinib Stada, Nilotinib Zentiva
- France
- Nilotinib Arrow, Nilotinib Biogaran, Nilotinib Cipla, Nilotinib Eg Labo, Nilotinib Olpha, Nilotinib Teva, Nilotinib Viatris, Nilotinib Zentiva
- Greece
- Lobynia, Nilotinib Anabiosis, Nilotinib Bioars, Nilotinib Olpha, Nilotinib Stada, Nilotinib Teva
- Hungary
- Krufton, Nilotinib
- Iceland
- Nilotinib, Tasigna
- Ireland
- Nilotinib Clonmel, Nilotinib Olpha
- Italy
- Nilotinib Cipla, Nilotinib Eg, Nilotinib Mylan, Nilotinib Teva, Nilotinib Zentiva
- Latvia
- Krufton, Nilotinib Olpha, Nilotinib Stada, Nilotinib Teva, Nilotinib Viatris, Nilotinib Zentiva
- Liechtenstein
- Nilotinib Accord, Tasigna
- Lithuania
- Krufton, Nilotinib Olpha, Nilotinib Stada, Nilotinib Viatris, Nilotinib Zentiva
- Luxembourg
- Nilotinib Eg, Nilotinib Eugia, Nilotinib Olpha
- Malta
- Nilotinib Hydrochloride Dihydrate Clonmel, Nilotinib Olpha, Nilotinib Pharos, Nilotinib Torrent
- Netherlands
- Nilotinib Cf, Nilotinib Cipla, Nilotinib Eugia, Nilotinib Teva, Nilotinib Viatris
- Norway
- Nilotinib Accord, Nilotinib Cipla, Nilotinib Olpha, Nilotinib Stada, Nilotinib Teva, Nilotinib Viatris, Nilotinib Zentiva, Tasigna
- Poland
- Nilotinib Stada, Nilotinib Viatris, Nilotinib Zentiva
- Portugal
- Nilotinib Eugia, Nilotinib Generis, Nilotinib Helm, Nilotinib Mylan, Nilotinib Olpha, Nilotinib Stada, Nilotinib Teva, Nilotinib Zentiva
- Romania
- Krufton, Nilotinib Cipla, Nilotinib Olpha, Nilotinib Stada, Nilotinib Zentiva
- Slovakia
- Krufton, Nilotinib
- Slovenia
- Nilmat, Nilotinib Stada, Nilotinib Teva
- Spain
- Nilotinib Cipla, Nilotinib Eugia, Nilotinib Stada, Nilotinib Teva, Nilotinib Zentiva
- Sweden
- Nilotinib Cipla, Nilotinib Devatis, Nilotinib Stada, Nilotinib Teva, Nilotinib Zentiva
EMA – Article 57 product data (EU/EEA), 2026-10-29
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Sources
- European Medicines Agency. Tasigna – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/tasigna-epar-product-information_en.pdf
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.