ponatinib
Iclusig · ATC code L01EA05
- Key facts
- Active substance
- ponatinib
- ATC code
- L01EA05
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Iclusig 15 mg film-coated tablets / Iclusig 30 mg film-coated tablets / Iclusig 45 mg film-coated tablets · Iclusig 5 mg hard capsules
- Marketing authorisation holder
- Incyte Biosciences Distribution B.V.
- Information as of
- 2026-10-28
Key facts
Ponatinib is a tyrosine kinase inhibitor that inhibits BCR-ABL, including the T315I mutation, among others. It is used for chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL).
What it is used for
- Iclusig film-coated tablets, monotherapy in adults: chronic, accelerated or blast phase CML resistant or intolerant to dasatinib or nilotinib (when imatinib is not appropriate), or with the T315I mutation.
- Iclusig film-coated tablets, monotherapy in adults: Ph+ ALL resistant or intolerant to dasatinib (when imatinib is not appropriate) or with the T315I mutation; also newly diagnosed Ph+ ALL in combination with reduced-intensity chemotherapy.
- Iclusig film-coated tablets and hard capsules: monotherapy of chronic phase CML in children 6 years of age or older under the same conditions.
Dosing
- Adults with previously treated CML or Ph+ ALL, or T315I mutation: starting dose 45 mg once daily; consider stopping if no complete haematologic response by 3 months (90 days).
- Chronic phase CML with molecular response: consider reducing to 15 mg; with loss of response re-escalate to a previously tolerated 30 mg or 45 mg.
- Adults with newly diagnosed Ph+ ALL: 30 mg once daily with chemotherapy, reduced to 15 mg upon MRD-negative complete response at the end of induction.
- Children 6 years and older: weight-based dosing – see the full text.
- Strong CYP3A inhibitors: consider reducing the adult starting dose to 30 mg. Assess cardiovascular status before starting; hepatic impairment: usual starting dose, with caution.
Contraindications
- Hypersensitivity to the active substance or to any of the excipients.
Important warnings
- Arterial occlusions, including fatal myocardial infarction and stroke, retinal arterial occlusion and severe peripheral vascular disease, also in patients without risk factors; the risk is likely dose-related.
- Venous thromboembolism and heart failure; interrupt treatment immediately if suspected.
- Myelosuppression (thrombocytopenia, neutropenia, anaemia): blood counts every 2 weeks for the first 3 months, then monthly.
- Hypertension, pancreatitis and lipase elevation, aneurysms and artery dissections.
- Hepatotoxicity including hepatic failure; check liver function before starting and periodically.
Side effects
- Most common serious adverse reactions (PACE study): pneumonia (7.3%), pancreatitis (5.8%), abdominal pain (4.7%), atrial fibrillation (4.5%), pyrexia (4.5%), myocardial infarction (4.0%).
- Serious arterial cardiovascular, cerebrovascular and peripheral vascular occlusive reactions in 10%, 7% and 9% of patients; serious venous occlusive reactions in 5%.
- Very common, among others: cough, constipation, nausea, lipase increased, transaminases increased, rash, dry skin, pruritus.
Interactions
- Strong CYP3A inhibitors (e.g. clarithromycin, itraconazole, ketoconazole, ritonavir, voriconazole, grapefruit juice) increase ponatinib exposure – use caution and consider dose reduction.
- For other interactions (e.g. CYP3A inducers) see the full text.
Pregnancy and breastfeeding
- Use effective contraception during treatment; as it is unknown whether hormonal contraceptives are affected, use an alternative or additional method.
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)
- IclusigIncyte Biosciences Distribution B.V. · EMEA/H/C/002695
Source: European Medicines Agency (EMA), product information
Turkey
- IclusigGEN İLAÇ VE SAĞLIK ÜRÜNLERİ SAN. VE TİC. A.Ş. · 3 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Iclusig
- Liechtenstein
- Iclusig
- Norway
- Iclusig
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Iclusig – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/iclusig-epar-product-information_en.pdf
- 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.