GLASDEGIB TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Unable to comply with recommended laboratory monitoring
- Baseline QTc > 470 msec
- Severe renal impairment (<30 mL/min) – has not been studied
- Severe hepatic impairment (LFT>3x ULN) – has not been studied
- Pregnancy (i.e. known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Prescriber is a VA or VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- ECOG performance status 0-2
- New diagnosis of previously untreated, acute myeloid leukemia (AML)
- Not eligible (or declines) intensive induction chemotherapy
- No actionable mutations (e.g. FLT3 mutation)
- Able to receive concurrent low-dose subcutaneous cytarabine
- Medication profile reviewed for concomitant CYP3A inducers, inhibitors and QTc prolonging drugs for glasdegib dose adjustment
- For female patients of child-bearing potential: provided counseling on effective contraception, and risk vs. benefit of treatment. Continue contraception for at least 30 days after final dose.
- For male patients with partners of child-bearing potential: provided counseling on effective contraception and potential risks vs. benefit of treatment. Continue contraception for at least 30 days after final dose.