Table 3.
Initial dose recommendations for ruxolitinib in adult patients according to indication
| Disease | Starting dose | Concomitant strong CYP3A4 inhibitor | Severe renal impairment (< 30 mL/min) | Liver impairment |
|---|---|---|---|---|
| MF | 5 mg, 10 mg, 15 mg or 20 mg BID depending on platelet count | Reduce dose by approximately 50% | Reduce dose by approximately 50% | Reduce dose by approximately 50% or reduce to 10 mg BID |
| PV | 10 mg BID | Reduce dose by approximately 50% | Starting dose 5 mg BID or reduce dose by approximately 50% | Reduce dose by approximately 50% |
| aGVHDa |
10 mg BID (EMA label) 5 mg BID (FDA label) |
Reduce dose by approximately 50% | Reduce dose by approximately 50% | Reduce dose by approximately 50% |
| cGVHDa | 10 mg BID | Reduce dose by approximately 50% | Reduce dose by approximately 50% | Reduce dose by approximately 50% |
aGVHD acute graft-versus-host disease, BID twice a day, cGVHD chronic graft-versus-host disease, CYP3A4 cytochrome P450 3A4, MF myelofibrosis, PV polycythemia vera
aApproved for use in patients > 12 years of age