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. 2022 Apr 20;27(8):685–693. doi: 10.1093/oncolo/oyac076

Table 1.

Overview of recent FDA-approved agents for GVHD

Agent Mechanism of action FDA-approved indication Recommended starting dosage Key toxicity considerations
Ruxolitinib Selective inhibition of Janus kinases 1 and 2 Adult or pediatric patients 12 years and older with steroid-refractory acute GVHD 5 mg orally twice daily Thrombocytopenia
Anemia
Neutropenia
CMV infection
Peripheral edema
Sepsis
Pulmonary Hemorrhage
Adult or pediatric patients 12 years and older with chronic GVHD after failure of one or two lines of systemic therapy 10 mg orally twice daily
Ibrutinib Selective inhibition of Bruton’s tyrosine kinase Adult patients with chronic GVHD after failure of one or more lines of systemic therapy 420 mg orally once daily Fatigue
Diarrhea
Muscle spasms
Pneumonia
Atrial arrhythmias
Fungal infections
Belumosudil Selective inhibition of rho-associated coiled-coil-containing protein kinase-2 Adult or pediatric patients 12 years and older with chronic GVHD after failure of at least 2 prior lines of systemic therapy 200 mg orally once daily Fatigue
Diarrhea
Nausea
URI
Pneumonia
Hypertension
Hyperglycemia
Elevated Liver Function Tests

Abbreviations: CMV, cytomegalovirus; FDA, US Food and Drug Administration; GVHD, graft-versus-host disease; mg, milligram; URI, upper respiratory tract infection.