IDELALISIB TAB,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Unable to swallow oral capsules whole and intact
- History of non-adherence with oral medication, follow-up appointments or laboratory visits
- Unmanageable drug interaction identified
- History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis
- Gastrointestinal condition that may interfere with absorption
- Chronic or unresolved infection
- Severe renal impairment defined as CrCl < 15 ml/min (drug has not been studied in this setting)
- AST (SGOT) or ALT (SGPT) > 2.5x ULN, bilirubin > 1.5x ULN, or with moderate-severe hepatic impairment (Child-Pugh B or C)
- Absolute Neutrophil Count (ANC) < 1000 cells/µL, and/or platelet count < 50,000 cells/µL unless bone marrow involvement
- Pregnancy (known pregnancy or positive pregnancy test)
- Breastfeeding
Inclusion Criteria
- Care provided by VA or VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 – 2
Indication
- Relapsed Chronic Lymphocytic Leukemia (CLL) with rituximab (if rituximab alone is appropriate due to comorbidities)
Reproductive Health & Contraception Requirements
- Pregnancy should be excluded prior to receiving idelalisib and the patient provided contraceptive counseling on potential risk vs. benefit of taking idelalisib if patient were to become pregnant
- Effective contraception should be used during treatment and for 1 month after the last dose
- Partners should use effective contraception for 3 months after last dose