DAUNORUBICIN/ CYTARABINE INJ,LYPHL
Clinical Criteria Summary
Exclusion Criteria
- Hypersensitivity to daunorubicin, cytarabine or any of its components
- Pregnancy (known pregnancy or positive pregnancy test) and/or actively breastfeeding
- Prior cumulative anthracycline exposure > 368 mg/m2 daunorubicin or equivalent
- Class III or IV heart failure symptoms (NYHA staging system)
- Left Ventricular Ejection Fraction < 50% (via echo, MUGA, MRI, etc.)
- Uncontrolled infection
- History of Wilson’s disease or another copper-metabolism disorder
- Tbili > 2.0 mg/dL (unless with Gilbert’s Syndrome); ALT or AST > 3x ULN
- Severe renal impairment or end-stage renal disease, defined as Clcr < 30 ml/min
Inclusion Criteria
- Diagnosis of therapy-related AML (t-AML) OR diagnosis of AML with myelodysplasia-related changes (AML-MRC) OR diagnosis of AML with antecedent MDS or CMML
- Patient has not received treatment for newly-diagnosed t-AML, AML-MRC or with antecedent MDS or CMML
- Goals of care and role of Palliative Care Consult have been discussed and documented
- ECOG Performance Status 0-2
- For women of childbearing potential: Pregnancy must be excluded prior to receiving; contraceptive counseling on risks vs. benefits provided; effective contraception advised during treatment and for at least 6 months after last dose; males with female partners of reproductive potential advised to use effective contraception during treatment and for at least 6 months after last dose, with counseling that fertility may be compromised; women advised not to breastfeed during treatment and for at least 2 weeks after last dose.
Monitoring
- Prior to induction: evaluate cardiac function, renal and liver function tests
- TLS parameters for those at risk
- Prior to each consolidation cycle: evaluate cardiac function, CBC, renal and liver function tests
- Pregnancy test (in women of childbearing potential) at baseline
Discontinuation Criteria
- Signs or symptoms of acute copper toxicity
- Severe infusion reaction or any life-threatening hypersensitivity reaction
- Worsening cardiac function, unless benefit outweighs risk (consider cardiology consultation)
- Decline in ECOG performance status to level unacceptable to maintain quality of life
Dosage & Administration / Clinical Considerations
- Refer to Product Information for dosing, dose modifications and administration details
- Boxed warning: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS
- Antiemetic potential per ASCO Clinical Practice Guidelines 2017: moderate
- Use appropriate measure to prevent Tumor Lysis Syndrome (TLS)
- Due to prolonged neutropenia expected following treatment, provide standard antimicrobial prophylaxis for induction of acute leukemia
- Consider risks vs. benefits in patients with Wilson’s disease, as use in this population has not been studied
- Concomitant cardiotoxic drugs may increase risk of cardiotoxicity, necessitating more frequent cardiac function assessment
- Concomitant hepatotoxic drugs may affect liver function, increasing toxicity and necessitating more frequent liver function assessment