There was no clinically meaningful impact of the increase in exposure dose modification is not required in patients with mild or moderate hepatic impairment. Patients should not take extra doses to make up the missed dose.īelumosudil exposure increased in patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment (see section 5.2). If a patient vomits following the intake of a dose, the next dose should be taken at the usual time the following day. If a dose is missed or delayed for more than 12 hours after the scheduled dose, the dose should be taken at the usual time the following day. If a dose is missed or delayed for less than 12 hours after the scheduled dose, the dose should be taken as soon as possible on the same day with a return to the normal schedule the following day. Increase the dosage of Rezurock to 200 mg twice daily when co-administered with proton pump inhibitors. Increase the dosage of Rezurock to 200 mg twice daily when co-administered with strong CYP3A inducers. Strong CYP3A4 inducers and Proton Pump Inhibitors decrease the exposure of belumosudil (see section 4.5). See section 4.8.ĭose modification due to drug interactions Toxicity grades are in accordance with National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.3 (NCI-CTCAE v4.3). *Grade 1 is mild, Grade 2 is moderate, Grade 3 is severe, Grade 4 is life-threatening. Hold Rezurock until recovery to ≤ Grade 1, then resume Rezurock at the recommended dose at physician's discretion.ĪLT = alanine aminotransferase AST = aspartate aminotransferase ULN = upper limit of normal.
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