Active Ingredient: Ruxolitinib
Ruxolitinib is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, between 5 milligrams ruxolitinib and 10 milligrams ruxolitinib, 2 times daily.
Regimen B: Oral, 5 milligrams ruxolitinib, once daily.
The recommended starting dose of ruxolitinib in acute and chronic graft versus host disease (GvHD) is 10 mg given orally twice daily. Ruxolitinib can be added to the continued use of corticosteroids and/or calcineurin inhibitors (CNIs).
Dose reductions and temporary interruptions of treatment may be needed in GvHD-patients with thrombocytopenia, neutropenia, or elevated total bilirubin after standard supportive therapy including growth-factors, anti-infective therapies and transfusions. One dose level reduction step is recommended (10 mg twice daily to 5 mg twice daily or 5 mg twice daily to 5 mg once daily). In patients who are unable to tolerate ruxolitinib at a dose of 5 mg once daily, treatment should be interrupted. Detailed dosing recommendations are provided in the following table.
Dosing recommendations during ruxolitinib therapy for GvHD patients with thrombocytopenia, neutropenia or elevated total bilirubin:
| Laboratory parameter | Dosing recommendation |
|---|---|
| Platelet count <20,000/mm³ | Reduce ruxolitinib by one dose level. If platelet count ≥20,000/mm³ within seven days, dose may be increased to initial dose level, otherwise maintain reduced dose. |
| Platelet count <15,000/mm³ | Hold ruxolitinib until platelet count ≥20,000/mm³, then resume at one lower dose level. |
| Absolute neutrophil count (ANC) ≥500/mm³ to <750/mm³ | Reduce ruxolitinib by one dose level. Resume at initial dose level if ANC >1,000/mm³. |
| Absolute neutrophil count <500/mm³ | Hold ruxolitinib until ANC >500/mm³, then resume at one lower dose level. If ANC >1,000/mm³, dosing may resume at initial dose level. |
| Total bilirubin elevation not caused by GvHD (no liver GvHD) | >3.0 to 5.0 x upper limit of normal (ULN): Continue ruxolitinib at one lower dose level until ≤3.0 x ULN. |
| >5.0 to 10.0 x ULN: Hold ruxolitinib up to 14 days until total bilirubin ≤3.0 x ULN. If total bilirubin ≤3.0 x ULN dosing may resume at current dose. If not ≤3.0 x ULN after 14 days, resume at one lower dose level. | |
| >10.0 x ULN: Hold ruxolitinib until total bilirubin ≤3.0 x ULN, then resume at one lower dose level. | |
| Total bilirubin elevation caused by GvHD (liver GvHD) | >3.0 x ULN: Continue ruxolitinib at one lower dose level until total bilirubin ≤3.0 x ULN. |
Ruxolitinib is to be taken orally, with or without food.
If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
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