Active Ingredient: Belumosudil
Belumosudil is indicated for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Oral, 200 milligrams belumosudil, once daily to meals.
The recommended dose of belumosudil is 200 mg given orally once daily until progression of chronic GVHD that requires new systemic therapy.
If a dose is missed, instruct the patient to not take extra doses to make up the missed dose.
Treatment with belumosudil has not been studied in patients with pre-existing severe renal impairment. For patients with pre-existing severe renal impairment, consider the risks and potential benefits before initiating treatment with belumosudil.
Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly.
Modify the belumosudil dosage for adverse reactions as per the following table.
Recommended dosage modifications for belumosudil for adverse reactions:
| Adverse Reaction | Severity* | Belumosudil Dosage Modifications |
|---|---|---|
| Hepatotoxicity | Grade 3 AST or ALT (5× to 20× ULN) or Grade 2 bilirubin (1.5× to 3× ULN) | Hold belumosudil until recovery of bilirubin, AST and ALT to Grade 0–1, then resume belumosudil at the recommended dose. |
| Grade 4 AST or ALT (more than 20× ULN) or Grade ≥3 bilirubin (more than 3× ULN) | Discontinue belumosudil permanently. | |
| Other adverse reactions | Grade 3 | Hold belumosudil until recovery to Grade 0–1, then resume belumosudil at the recommended dose level. |
| Grade 4 | Discontinue belumosudil permanently. |
* Based on CTCAE v 4.03
Take belumosudil with a meal at approximately the same time each day.
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