Medically reviewed by Drugs.com. Last updated on Jul 11, 2022.
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 [see Clinical Pharmacology (12.3)].
- 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 or hepatic impairment. For patients with pre-existing severe renal or hepatic impairment, consider the risks and potential benefits before initiating treatment with REZUROCK [see Clinical Pharmacology (12.3)].
Dose 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.
|Adverse Reaction||Severity*||REZUROCK Dosage Modifications|
|Hepatotoxicity [see Adverse Reactions (6.1)]||Grade 3 AST or ALT (5× to 20× ULN) or Grade 2 bilirubin (1.5× to 3× ULN)||Hold REZUROCK until recovery of bilirubin, AST and ALT to Grade 0–1, then resume REZUROCK at the recommended dose.|
|Grade 4 AST or ALT (more than 20× ULN) or Grade ≥3 bilirubin (more than 3× ULN)||Discontinue REZUROCK permanently.|
|Other adverse reactions [see Adverse Reactions (6.1)]||Grade 3||Hold REZUROCK until recovery to Grade 0–1, then resume REZUROCK at the recommended dose level.|
|Grade 4||Discontinue REZUROCK permanently.|
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 [see Drug Interactions (7.1)].
Proton Pump Inhibitors
Increase the dosage of REZUROCK to 200 mg twice daily when coadministered with proton pump inhibitors [see Drug Interactions (7.1)].
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