← Back to Drug List

IBRUTINIB CAP,ORAL

Clinical Criteria Summary

This criteria document covers 3 drugs .
See all drugs in this document
  • IBRUTINIB CAP,ORAL
  • IBRUTINIB SUSP,ORAL
  • IBRUTINIB TAB,ORAL

Criteria for Ibrutinib (CAP, ORAL; SUSP, ORAL; TAB, ORAL)

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), in patients with acceptable indications for treatment, 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 (Select if applicable)

  • 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 during treatment and for 1 week after last dose

Additional Inclusion Criteria (All must be met)

  • 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

Source Documents