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asciminib

Scemblix · ATC code L01EA06

Also known as: Asiminib

Key facts
Active substance
asciminib
ATC code
L01EA06
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Scemblix 20 mg film-coated tablets / Scemblix 40 mg film-coated tablets / Scemblix 100 mg film-coated tablets
Marketing authorisation holder
Novartis Europharm Limited
Information as of
2026-10-28

Key facts

Asciminib is a BCR::ABL1 tyrosine kinase inhibitor used to treat Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase in adults (Scemblix, film-coated tablets).

What it is used for

  • Adults with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP).
  • Adults with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib.

Dosing

  • Ph+ CML-CP: total daily dose 80 mg, either 80 mg once daily or 40 mg twice daily at approximately 12-hour intervals.
  • Ph+ CML-CP with T315I mutation: 200 mg twice daily at approximately 12-hour intervals; the 100 mg tablets are restricted to this indication.
  • Dose reduction for adverse reactions: to 40 mg once daily or 20 mg twice daily (T315I: 160 mg twice daily); permanently discontinue if that dose is not tolerated. Details: see the full text.
  • Take without food: avoid food for at least 2 hours before and 1 hour after the dose; swallow tablets whole.
  • Missed dose: take it if missed by less than 12 hours (once daily) or 6 hours (twice daily), otherwise skip it.
  • Continue as long as clinical benefit is observed or until unacceptable toxicity.

Contraindications

  • Hypersensitivity to the active substance or any excipient.

Important warnings

  • Myelosuppression (thrombocytopenia, neutropenia, anaemia): complete blood counts every two weeks for the first 3 months, then monthly.
  • Pancreatic toxicity: assess lipase and amylase monthly; if accompanied by abdominal symptoms, withhold treatment and exclude pancreatitis.
  • QT prolongation: ECG before starting; correct hypokalaemia and hypomagnesaemia beforehand.
  • Hypertension, including severe hypertension, has occurred; monitor regularly.
  • Test for hepatitis B infection before starting (reactivation with other BCR::ABL1 TKIs).
  • With 200 mg twice daily, close monitoring should be considered because safety data are limited (48 patients).

Side effects

  • Ph+ CML, most common (≥20%): musculoskeletal pain (34.4%), thrombocytopenia (28.1%), fatigue (25.4%), upper respiratory tract infections (24.8%), headache (22.8%), neutropenia (21.8%), arthralgia and diarrhoea (each 20.7%).
  • Most common grade ≥ 3: thrombocytopenia (16.5%), neutropenia (13.8%), increased pancreatic enzymes (9.4%), hypertension (9.2%).
  • Serious adverse reactions occurred in 9.9% of patients, including pleural effusion, lower respiratory tract infections and pancreatitis.

Interactions

  • Medicines with known risk of torsades de pointes (e.g. clarithromycin, haloperidol, methadone, moxifloxacin): caution at 80 mg/day, avoid with 200 mg twice daily.
  • Strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, St. John's wort) may lower efficacy; caution.
  • Strong CYP3A4 inhibitors: caution with 200 mg twice daily; no dose adjustment required.
  • Caution with narrow-therapeutic-index CYP3A4 substrates (e.g. fentanyl, alfentanil, ergotamine).

Pregnancy and breastfeeding

  • Not recommended during pregnancy; women of childbearing potential should use effective contraception during treatment and for at least 3 days after stopping.
  • Breast-feeding should be discontinued during treatment and for at least 3 days after stopping.

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.

Full official text →

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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)

  • ScemblixNovartis Europharm Limited · EMEA/H/C/005605

Source: European Medicines Agency (EMA), product information

Turkey

  • AzevayFARMANOVA SAĞLIK HİZMETLERİ LTD. ŞTİ. · 2 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Scemblix
Liechtenstein
Scemblix
Norway
Scemblix

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

  1. European Medicines Agency. Scemblix – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/scemblix-epar-product-information_en.pdf
  2. 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.