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ivosidenib

Tibsovo · ATC code L01XM02

Also known as: İvosidenib

Key facts
Active substance
ivosidenib
ATC code
L01XM02
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Tibsovo 250 mg film-coated tablets
Marketing authorisation holder
Les Laboratoires Servier
Information as of
2026-10-29

Key facts

Ivosidenib is an inhibitor of mutant isocitrate dehydrogenase-1 (IDH1). It is used in IDH1 R132-mutated acute myeloid leukaemia (with azacitidine) and in cholangiocarcinoma.

What it is used for

  • With azacitidine: adults with newly diagnosed acute myeloid leukaemia (AML) with an IDH1 R132 mutation who are not eligible for standard induction chemotherapy (Tibsovo).
  • Monotherapy: adults with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation previously treated with at least one line of systemic therapy.

Dosing

  • An IDH1 R132 mutation must be confirmed with an appropriate test before starting.
  • AML: 500 mg (2 x 250 mg tablets) once daily on days 1-28 of each cycle, with azacitidine 75 mg/m2 on days 1-7 of each 28-day cycle; at least 6 cycles recommended.
  • Cholangiocarcinoma: 500 mg once daily until progression or intolerance.
  • If moderate or strong CYP3A4 inhibitors cannot be avoided: reduce to 250 mg once daily.
  • ECG before starting (QTc less than 450 msec), at least weekly for the first 3 weeks, then monthly; regular blood counts and chemistries. A missed dose can be taken within 12 hours. See the full text for dose modifications for adverse reactions.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.
  • Concomitant strong CYP3A4 inducers or dabigatran.
  • Congenital long QT syndrome, family history of sudden death or polymorphic ventricular arrhythmia, QT/QTc > 500 msec.

Important warnings

  • Differentiation syndrome in AML, which may be life-threatening or fatal if untreated: if suspected, give systemic corticosteroids and monitor haemodynamics; carry the Patient Alert Card at all times.
  • QTc prolongation: monitor ECG and electrolytes, especially with heart failure, electrolyte abnormalities or QT-prolonging medicines.
  • Ivosidenib may reduce hormonal contraceptive levels; an additional barrier method is recommended. See the full text for further warnings.

Side effects

  • AML (with azacitidine): vomiting (40%), neutropenia (31%), thrombocytopenia (28%), electrocardiogram QT prolonged (21%), insomnia (19%); the main serious reaction was differentiation syndrome (8%).
  • Cholangiocarcinoma: fatigue (43%), nausea (42%), abdominal pain (35%), diarrhoea (35%), decreased appetite (24%), ascites (23%), vomiting (23%), anaemia (19%), rash (15%).

Interactions

  • Strong CYP3A4 inducers (e.g. carbamazepine, phenobarbital, phenytoin, rifampicin, St John's wort) are contraindicated.
  • Moderate or strong CYP3A4 inhibitors (e.g. clarithromycin, itraconazole, fluconazole, diltiazem, grapefruit) increase levels and QTc risk; avoid where possible, otherwise reduce the dose.
  • Avoid other QTc-prolonging medicines where possible.

Pregnancy and breastfeeding

  • Pregnancy test before starting; not recommended during pregnancy. Effective contraception (also for men with partners of childbearing potential) during and for at least 1 month after treatment.
  • Do not breast-feed during treatment and for at least 1 month 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.

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)

  • TibsovoLes Laboratoires Servier · EMEA/H/C/005936

Source: European Medicines Agency (EMA), product information

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

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.

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Sources

  1. European Medicines Agency. Tibsovo – EPAR, Product Information. 2026-10-29. https://www.ema.europa.eu/en/documents/product-information/tibsovo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-29 · 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.