IVOSIDENIB TAB
Clinical Criteria Summary
Exclusion Criteria
- Inability to swallow whole tablets
- Severe renal impairment (CrCl < 30 ml/min)
- Severe hepatic impairment (Child-Pugh C)
- Baseline QTc > 450 msec and/or history of long QT syndrome
- Clinically significant cardiovascular disease (uncontrolled or symptomatic arrhythmias, CHF NYHA Class 3 or 4, myocardial infarction in prior 6 months)
- Unmanageable CYP3A4 inducer/inhibitor and/or QTc-prolonging drug interaction
- Chronic or unresolved infection
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
General Inclusion Criteria
- Care provided by a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult discussed and documented
- ECOG performance status 0-2
- Presence of an isocitrate dehydrogenase-1 (IDH-1) mutation
Disease-Specific Indications
- Relapsed/refractory acute myeloid leukemia: Relapsed disease after 2 previous inductions OR relapsed disease after 1 induction and not suitable for intensive chemotherapy
- Newly diagnosed acute myeloid leukemia: Age > 75 years OR not a candidate for intensive induction therapy
- Locally advanced or metastatic cholangiocarcinoma: After 1 prior gemcitabine-based or fluorouracil-based regimen
Reproductive & Safety Requirements
- Pregnancy must be excluded prior to receiving ivosidenib
- Provide contraceptive counseling on potential risks vs. benefits of taking ivosidenib if patient were to become pregnant
- Advise against breastfeeding during treatment and for at least 1 month after the last dose