420

mg

Oral

once a day

continued until recurrence of underlying malignancy

420

mg

Capsule

Orally 

once a day

continue the dose until recurrence of underlying malignancy

ruxolitinib is a therapeutic agent for the treatment of cGVHD in the patients who have failed the treatment of systemic therapy
A dose of 10 mg is administered orally twice daily, which can be reduced after six months of the therapy

200 mg orally daily
Dosage Modifications
Hepatotoxicity
Grade 3 AST: put on hold till recovery of bilirubin, ALT, and AST to Grade 0-1, then start as per suggested dose
Grade 4 AST: discontinue forever
Other adverse reactions
Grade 3: put on hold till recovery to Grade 0-1, then start as per suggested dose
Grade 4: discontinue forever
Renal impairment
Mild-to-moderate: dose modification not required
Severe: study not performed
Patients with pre-existing severe renal impairment: study not performed
Hepatic impairment
Patients with pre-existing severe hepatic impairment: study not performed
Strong CYP3A4 inducers
Raise dose to 200 mg orally two times daily, if co-administered
Proton pump inhibitors
Raise dose to 200 mg orally two times daily, if co-administered
Dosing Considerations
Monitoring parameters
Monitor ALT, total bilirubin and AST once in a month

FDA approval pending for steroid-refractory acute graft-versus-host disease (aGvHD) for grade 2 to 4

Administer dose of 0.3 mg/kg through intravenous route for every 2 weeks

No safe and efficacious dosage is available

Safety and efficacy not determined in less than twelve years old
≥12 years: 200 mg orally daily
Dosage Modifications
Hepatotoxicity
Grade 3 AST: put on hold till recovery of bilirubin, ALT, and AST to Grade 0-1, then start as per suggested dose
Grade 4 AST: discontinue forever
Other adverse reactions
Grade 3: put on hold till recovery to Grade 0-1, then start as per suggested dose
Grade 4: discontinue forever
Renal impairment
Mild-to-moderate: dose modification not required
Severe: study not performed
Patients with pre-existing severe renal impairment: study not performed Hepatic impairment
Patients with pre-existing severe hepatic impairment: study not performed
Strong CYP3A4 inducers
Raise dose to 200 mg orally two times daily, if co-administered
Proton pump inhibitors
Raise dose to 200 mg orally two times daily, if co-administered
Dosing Considerations
Monitoring parameters
Monitor ALT, total bilirubin and AST once in a month

For ≥40 kg:
Administer dose of 0.3 mg/kg through intravenous route for every 2 weeks

Refer adult dosing