Active Ingredient: Belumosudil
Belumosudil is indicated for the treatment of adults and paediatric patients (12 years and older with a body weight of at least 40 kg) with chronic graft-versus-host disease (cGVHD) when other treatment options provide limited clinical benefit, are not suitable or have been exhausted.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In the case that patient weight is ≥ 40 kg :
Oral, 200 milligrams belumosudil, once daily to meals.
The recommended dose is 200 mg given orally once daily with a meal.
Treatment is recommended until disease progression or unacceptable toxicity.
A complete blood cell counts and liver function tests must be performed before initiating therapy. Initiation of belumosudil in patients with platelets <50 × 109/L or absolute neutrophil count <1.5 × 109/L should be based on close monitoring of laboratory values and clinical assessment.
Liver function tests must be performed at least monthly throughout treatment.
The recommended dose modifications in case of adverse reactions are provided in Table 1.
Table 1. Recommended dose modifications in case of adverse reactions:
| Adverse reaction | Severity* | Dose modification |
| Hepatotoxicity | Grade 3 ALT or AST (>5 to 20 × ULN) or Grade 2 bilirubin (>1.5 to 3 × ULN) | Hold treatment until recovery to ≤ Grade 1, then resume belumosudil recommended dose and monitor laboratory tests for toxicity. |
| Grade 4 ALT or AST (>20 × ULN) or Grade ≥3 bilirubin (>3 × ULN) | Permanently discontinue treatment. | |
| Other adverse reactions | Grade 3 | Hold treatment until recovery to ≤ Grade 1, then resume belumosudil recommended dose and monitor for toxicity. |
| Grade 4 | Permanently discontinue treatment. |
ALT = alanine aminotransferase; AST = aspartate aminotransferase; ULN = upper limit of normal
* Grade 1 is mild, Grade2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03 (NCI-CTCAE v4.03)
In the event of a delayed or missed dose:
A dose should be taken as soon as possible on the same day if:
For the next dose, the usual schedule should be resumed.
A dose should not be taken if:
For the next dose, the usual schedule should be resumed.
If a patient vomits following the intake of a dose, the next dose should be taken at the usual time.
In case of missed dose, the patient should be instructed not to take extra doses to make up the missed dose.
Take belumosudil with a meal at approximately the same time every day.
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