GILTERITINIB TAB,ORAL
Clinical Criteria Summary
Patient Demographics & Reproductive Status
- Pregnancy (i.e. known pregnancy or positive pregnancy test)
- Breastfeeding
- Female patients of child-bearing potential: provided counseling on effective contraception and risk vs. benefit of treatment; continue contraception for at least 6 months after the final dose
- Male patients with partners of child-bearing potential: provided counseling on effective contraception and potential risk vs. benefit of treatment; continue contraception for at least 4 months after the final dose
Clinical Diagnosis & Performance Status
- Relapsed or refractory acute myeloid leukemia (AML) with FMS-like tyrosine kinase 3 (FLT3) mutation (i.e. ITD or TKD) as detected by an FDA-approved test
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Laboratory & Monitoring Requirements
- Unable to comply with recommended laboratory monitoring
- Baseline QTc > 500 msec
Medical Conditions & Organ Function
- Severe renal impairment (CrCl <30 ml/min) - has not been studied
- Severe hepatic impairment (Child-Pugh Class C) – has not been studied
Prescriber Qualifications & Documentation
- Prescriber is a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
Drug Interactions & Medication Profile Review
- Patient is on chronic therapy with a combined P-gp and strong CYP3A inducer (e.g. rifampin)
- Medication profile reviewed for concomitant CYP3A inhibitors which may increase gilteritinib concentrations and potential toxicity
- Medication profile reviewed for chronic SSRI therapy (e.g. escitalopram, fluoxetine, sertraline) as gilteritinib may reduce their effectiveness