Renal Dose Adjustment (Based on CrCl)
- 15-59 mL/min (Moderate-to-severe): Start with 10 mg PO bid for patients with platelet count between 100-150 x109/L; avoid use in patients with platelet counts <100 x109/L
- <15 mL/min (ESRD): Start with 15 mg PO bid for patients on dialysis and with platelet count between 100-200 x109/L; Start with 20 mg PO bid for patients on dialysis and with platelet >200 x109/L
- <15 mL/min (ESRD): Avoid use in patients not requiring dialysis
Notes:- Administer subsequent doses on dialysis days following each dialysis session
- Carefully monitor safety and efficacy for additional dose modifications
Hepatic Dose Adjustment
- Platelet count 100-150 x109/L: Start with 10 mg PO bid
- Platelet count <100 x109/L: Avoid use
Notes:- Carefully monitor safety and efficacy for additional dose modifications
- Refer package insert for dose modification for thrombocytopenia
See Supplemental Patient Information
- Therapy may cause hematologic adverse reactions, such as thrombocytopenia, anemia and neutropenia; if such event occurs consider dose reduction, or interruption or transfusion. Perform complete CBC before starting therapy with ruxolitinib
- Thrombocytopenia is more likely to occur in patients with platelet counts <200 x109/L at the start of therapy
- Thrombocytopenia is more likely to occur in patients with platelet counts <200 x109/L at the start of therapy. Reduce the dose or temporarily withhold therapy for management of thrombocytopenia. Platelet transfusions may be administered if clinically indicated
- Blood transfusions are required in patients developing anemia during course of therapy. Consider dose modifications for patients developing anemia
- Temporarily withheld therapy for patients with neutropenia (ANC <0.5 X 109/L)
- Monitor CBC as clinically indicated and adjust dosing as required
- Assess patients for the risk of developing serious bacterial, mycobacterial, fungal and viral infections. Serious infections should have resolved before initiating therapy with ruxolitinib. Tuberculosis has been reported in patients receiving therapy for myelofibrosis. Notice for the possibility of latent or active tuberculosis.Carefully observe patients for signs and symptoms of infection and promptly initiate appropriate therapy
- Concomitant use with strong CYP3A4 inhibitors with platelet counts <100 x109/L avoid use. Dose adjustments greater than 100 x109/L
- Progressive multifocal leukoencephalopathy (PML) has ben reported with the therapy; if suspected, discontinue drug and evaluate
Supplemental Patient Information
- Inform patients about early signs and symptoms of herpes zoster and advise them to seek treatment as early as possible
Pregnancy Category:C
Breastfeeding: Safety unknown. A decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
