LURBINECTEDIN INJ
Clinical Criteria Summary
Exclusion Criteria
- Immunocompromised patients including known HIV (unless HIV with normal CD-4 counts)
- Absolute neutrophil count (ANC) < 1500 cells/mm3 and platelet count <100,000/mm3
- Unmanageable strong or moderate CYP3A Inhibitor drug interaction identified (including grapefruit and Seville oranges)
- Concomitant strong CYP3A inducers
- Moderate-severe hepatic impairment (T bili > 1.5 times the upper limit of normal and any AST)
- Pregnancy (i.e. known pregnancy or positive pregnancy test)
- Lactating
Inclusion Criteria
- Care is provided by a VA/VA purchased care oncology provider
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Goals of care and role of Palliative Care consult have been discussed and documented
- Baseline CBC then prior to each administration; baseline LFT’s then periodically as indicated
Additional Inclusion Criteria
- Evidence of disease progression on or after platinum-based chemotherapy for metastatic small cell lung cancer (SCLC)
- Prophylaxis with antiemetic regimen for moderately emetogenic agent
- Use of granulocyte colony stimulating factor (GCSF) is recommended for ANC < 500 cells/mm3 as secondary prophylaxis
Reproductive Safety & Counseling Requirements
- Female patients of child-bearing potential: counseling provided on risks vs benefits of treatment and use of effective contraception during therapy and for 6 months after the last dose
- Male partners: counseling provided on risks vs benefits of treatment and use of effective contraception during therapy and for 4 months after the last dose