IBRUTINIB SUSP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Patient has not been screened for Hepatitis B Virus (HBV)
- Unmanageable drug-drug or drug-food interaction
- Active or uncontrolled infection
- History of stroke or intracranial hemorrhage in prior 6 months
- Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (NYHA Class 3 or 4) or myocardial infarction in prior 6 months
- Severe hepatic impairment (Child-Pugh C) or total bilirubin > 3x Upper Limit of Normal (unless non-hepatic origin or Gilbert syndrome)
- Known pregnancy
- Lactating
Inclusion Criteria
- Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) if acalabrutinib is not clinically appropriate for patient
- Waldenstrom Macroglobulinemia
- Previously treated chronic Graft versus Host Disease (cGVHD) after Hematopoietic Stem Cell Transplant
Additional Inclusion Criteria
- Care for the oncologic condition provided by VA or VA Community Care oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0 - 2
Pregnancy and Lactation Counseling Requirements
- For patients who can become pregnant and patients with partners who can become pregnant: Counseling provided on potential risks vs benefits of treatment and the use of effective contraception during therapy and for 1 month after stopping treatment
- Advise patients not to breastfeed/provide breastmilk during treatment and for 1 week after last dose