Medical Information

Belumosudil is a targeted therapy drug used for specific immune related diseases, with clear indications for chronic graft-versus-host disease. When using it, attention should be paid to liver function monitoring, infection risk, and medication adjustment for special populations. The following provides a detailed explanation from two aspects: indications and precautions, covering key information for clinical use.

1. Indications

Besudil is indicated for the treatment of chronic graft-versus-host disease (cGVHD) in adult and pediatric patients aged 12 years and older who have previously experienced at least second-line systemic treatment failure. This drug regulates immune response and improves cGVHD symptoms by selectively inhibiting the ROCK2 pathway.

2. Medication precautions

(1) Liver function monitoring

During the treatment period, liver function should be regularly monitored. If ALT/AST levels rise to more than 3 times ULN or bilirubin levels rise to 2 times ULN, medication should be suspended. After recovery, reducing dosage and restarting treatment may be considered.

(2) Risk of infection

May increase the risk of bacterial, fungal, or viral infections. Before medication, latent infections (such as HBV and tuberculosis) should be screened, and infection signs should be closely monitored during treatment. If necessary, preventive anti infective treatment should be carried out.

(3) Medication for special populations

Prohibited during pregnancy, women of childbearing age should adopt efficient contraception during treatment and within one week after discontinuation of medication; Suspend feeding during lactation period; Patients with mild to moderate liver damage should reduce their dosage, while those with severe liver damage should avoid using it; Elderly patients do not need to adjust the dosage but need to strengthen monitoring.

(4) Drug interactions

Avoid combination with potent CYP3A4 inhibitors, and reduce dosage by 50% when necessary; Combined use with CYP3A4 inducers may reduce efficacy and dosage adjustment should be considered.

(5) Adverse reaction management

Common adverse reactions include fatigue, diarrhea, and respiratory infections. The incidence of grade 3-4 adverse reactions is about 15%, and dosage adjustments or medication suspensions should be taken according to the severity.