BELUMOSUDIL TAB
Clinical Criteria Summary
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Exclusion Criteria
- Moderate or severe hepatic impairment (defined as Child-Pugh B or C)
- Unmanageable drug-drug-interaction
- Pregnancy
- Lactating
- Inability to monitor total bilirubin, AST and ALT at least monthly
- Inability to swallow tablets whole with a meal
Inclusion Criteria
- Care provided by a VA or VA Community Care hematology provider
- Eastern Cooperative Oncology Group Performance Status 0 - 2
- Diagnosis of chronic graft-versus-host disease (cGVHD) secondary to allogeneic hematopoietic stem cell transplant
- cGVHD disease progression after at least 2 prior lines of systemic therapy
Additional Inclusion Criteria
- For patients who can become pregnant: Pregnancy must be excluded prior to receiving belumosudil
- 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 one week after stopping treatment
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Indication & Patient Population
- Treatment of chronic graft vs. host disease (cGVHD)
- Patients status post allogeneic hematopoietic stem cell transplant (s/p AlloHCT)
- Persistent cGVHD in heavily pre-treated patients with progressive disease or contraindication to ibrutinib or ruxolitinib
Disease Severity & Classification Criteria
- Classified per NIH Consensus Criteria for organ scoring (Score 0-3) versus host disease grading by symptoms, affected organ systems, and extent of disease involvement
- Mild: < 2 affected organs; no clinically significant functional dysfunction
- Moderate: > 3 organs with no dysfunction or > 1 organ with dysfunction but no major disability
- Severe: Major disability
Prior Therapy Requirements
- Failure of at least 2 prior lines of therapy (specifically 2-5 prior lines per trial criteria)
- Applicable following prior ibrutinib and prior ruxolitinib therapy
Dosing & Administration
- 200 mg tablet
- 200 mg PO once daily with food
- Dose increase to 200 mg twice daily required when coadministered with strong CYP3A inducers or proton pump inhibitors
Contraindications & Precautions
- Avoid use in moderate or severe hepatic impairment
- Embryo-fetal toxicity warning
Performance Status & Supportive Care Criteria
- Karnofsky Performance Scale (KPS) > 60
- On stable corticosteroid (CS) therapy for at least 2 weeks prior to initiation