ivosidenib: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
ivosidenib: clinical details
Prescribing considerations
- Confirm an IDH1 R132 mutation using an appropriate diagnostic test.
- Initiate treatment under specialist supervision experienced in anticancer therapy.
- Review all medicines for CYP3A4, QT, transporter and enzyme-induction interactions.
- Use caution in severe renal impairment, any hepatic impairment, low albumin or underweight patients.
- Educate patients with AML about differentiation syndrome and ensure they carry the patient alert card.
Contraindications and cautions
- Hypersensitivity to ivosidenib or an excipient.
- Concurrent strong CYP3A4 inducers or dabigatran.
- Congenital long-QT syndrome.
- Family history of sudden death or polymorphic ventricular arrhythmia.
- QT or QTc interval above 500 milliseconds.
Monitoring
- Confirm baseline QT suitability and perform ongoing ECG monitoring.
- Check blood count and blood chemistry before and regularly during treatment.
- Assess potassium, magnesium and other electrolytes, particularly with severe vomiting or diarrhoea.
- Monitor AML patients for differentiation syndrome and leukocytosis.
- Monitor renal and hepatic function according to clinical risk and emerging toxicity.
Clinical pharmacology
Ivosidenib inhibits mutant IDH1, reducing 2-hydroxyglutarate and promoting cellular differentiation. It is primarily metabolised through CYP3A4, induces several CYP enzymes and UGTs, and affects P-glycoprotein, OAT3 and OATP1B1/1B3 transport pathways.
Formulation and product differences
- The selected product is an oral film-coated tablet containing lactose.
- The bottle contains a moisture-protecting desiccant that must not be swallowed and should remain in the tightly closed bottle.
ivosidenib interactions
A full interaction review is required before starting ivosidenib and whenever another treatment is added.
Strong CYP3A4 inducers, including rifampicin, carbamazepine, phenytoin, phenobarbital and St John's wort
These may substantially lower ivosidenib exposure and are contraindicated.
Moderate or strong CYP3A4 inhibitors, including clarithromycin, azole antifungals, ritonavir, diltiazem and verapamil
These increase ivosidenib exposure and the risk of QT prolongation, requiring an alternative where possible or specialist management and monitoring.
Medicines that prolong QT
Concurrent use can further increase the risk of dangerous heart-rhythm abnormalities.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.