Dosage of Rezurock

1. Recommended Dosage

The recommended dose of Rezurock is 200 mg given orally once daily until progression of chronic GVHD that requires new systemic therapy.  Instruct the patient on the following:

Swallow Rezurock tablets whole. Do not cut, crush, or chew tablets.

Take Rezurock with a meal at approximately the same time each day.

If a dose of Rezurock is missed, instruct the patient to not take extra doses to make up the missed dose.

Treatment with Rezurock has not been studied in patients with pre-existing severe renal  impairment. For patients with pre-existing severe renal impairment, consider the risks and  potential benefits before initiating treatment with Rezurock.

2. Dosage Modifications for Adverse Reactions

Monitor total bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT) at least monthly.

Modify the Rezurock dosage for adverse reactions as per Table 1.

3. Dosage Modification Due to Drug Interactions

Strong CYP3A Inducers

Increase the dosage of Rezurock to 200 mg twice daily when coadministered with strong  CYP3A inducers.  

Proton Pump Inhibitors

Increase the dosage of Rezurock to 200 mg twice daily when coadministered with proton pump inhibitors.

4. Recommended Dosage in Patients with Hepatic Impairment

Avoid use in patients with moderate hepatic impairment (Child-Pugh B) or severe hepatic impairment (Child-Pugh C) without liver GVHD.

No dosage adjustment is recommended when administering Rezurock to patients with mild hepatic impairment.

from FDA，2024.04