ZANUBRUTINIB CAP,ORAL
Clinical Criteria Summary
Exclusion Criteria
- Patient has not been screened for Hepatitis B Virus (HBV)
- Unmanageable drug-drug or drug-food interaction identified
- 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
- Current or history of Central Nervous System (CNS) lymphoma
- Active or uncontrolled infection
- Known pregnancy
- Lactating
Indications
- Relapsed or refractory mantle cell lymphoma and progressive disease or intolerance to at least one prior therapy
- Relapsed or refractory marginal zone lymphoma and received at least one anti-CD20-based regimen
- Waldenstrom macroglobulinemia
- Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) if acalabrutinib is not clinically appropriate for patient
- Relapsed or refractory follicular lymphoma, in combination with obinutuzumab, after two or more lines of therapy
Additional Clinical Requirements
- Care provided by a VA/VA Community Care hematology/oncology provider
- Goals of care and role of Palliative Care consult have been discussed and documented
- Eastern Cooperative Oncology Group Performance Status 0-2
- 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 week after the last dose
- Advise patients not to breastfeed/provide breastmilk during treatment and for at least 2 weeks after the last dose